Trial Outcomes & Findings for Effects of Lactobacillus Plantarum PS128 in Children With ASD (NCT NCT05307744)
NCT ID: NCT05307744
Last Updated: 2026-08-24
Results Overview
Social Responsiveness Scale can measure the autism clinical severity with the range from 65-260. The lower scores stand for better social responsiveness.
TERMINATED
NA
41 participants
Baseline, Week 12 and Week 16
2026-08-24
Participant Flow
Participant milestones
| Measure |
PS128
Subjects will take PS128 capsules every day (2 capsules/day, once) for 12 weeks.
PS128: Each PS128 capsule contained \>3 × 10\^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg.
|
Placebo
Subjects will take placebo capsules every day (2 capsules/day, once) for 12 weeks.
Placebo: The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose.
|
Normal Control
Normal control group are enrolled by invitation from the age and gender matched healthy children.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
21
|
0
|
|
Overall Study
COMPLETED
|
20
|
21
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The analysis sample excludes cases with medication adherence and those who did not follow up as scheduled.
Baseline characteristics by cohort
| Measure |
PS128
n=19 Participants
Subjects will take PS128 capsules every day (2 capsules/day, once) for 12 weeks.
PS128: Each PS128 capsule contained \>3 × 10\^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg.
|
Placebo
n=17 Participants
Subjects will take placebo capsules every day (2 capsules/day, once) for 12 weeks.
Placebo: The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose.
|
Normal Control
Normal control group are enrolled by invitation from the age and gender matched healthy children.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
9.2 years
STANDARD_DEVIATION 1.7 • n=19 Participants • The analysis sample excludes cases with medication adherence and those who did not follow up as scheduled.
|
8.5 years
STANDARD_DEVIATION 1.3 • n=17 Participants • The analysis sample excludes cases with medication adherence and those who did not follow up as scheduled.
|
—
|
8.9 years
STANDARD_DEVIATION 1.6 • n=36 Participants • The analysis sample excludes cases with medication adherence and those who did not follow up as scheduled.
|
|
Sex: Female, Male
Female
|
2 Participants
n=19 Participants • The analysis sample excludes cases with low medication adherence and those who did not follow up as scheduled.
|
3 Participants
n=17 Participants • The analysis sample excludes cases with low medication adherence and those who did not follow up as scheduled.
|
—
|
5 Participants
n=36 Participants • The analysis sample excludes cases with low medication adherence and those who did not follow up as scheduled.
|
|
Sex: Female, Male
Male
|
17 Participants
n=19 Participants • The analysis sample excludes cases with low medication adherence and those who did not follow up as scheduled.
|
14 Participants
n=17 Participants • The analysis sample excludes cases with low medication adherence and those who did not follow up as scheduled.
|
—
|
31 Participants
n=36 Participants • The analysis sample excludes cases with low medication adherence and those who did not follow up as scheduled.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Baseline, Week 12 and Week 16Population: The analysis sample excludes cases with low medication adherence and those who did not follow up as scheduled.
Social Responsiveness Scale can measure the autism clinical severity with the range from 65-260. The lower scores stand for better social responsiveness.
Outcome measures
| Measure |
PS128
n=19 Participants
Subjects will take PS128 capsules every day (2 capsules/day, once) for 12 weeks.
PS128: Each PS128 capsule contained \>3 × 10\^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg.
|
Placebo
n=17 Participants
Subjects will take placebo capsules every day (2 capsules/day, once) for 12 weeks.
Placebo: The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose.
|
Normal Control
Normal control group are enrolled by invitation from the age and gender matched healthy children.
|
|---|---|---|---|
|
Changes of Total Scores of Social Responsiveness Scale
Baseline
|
89.9 score on a scale
Standard Deviation 23.5
|
103.0 score on a scale
Standard Deviation 28.7
|
—
|
|
Changes of Total Scores of Social Responsiveness Scale
Week 12
|
87.0 score on a scale
Standard Deviation 24.8
|
91.9 score on a scale
Standard Deviation 32.0
|
—
|
|
Changes of Total Scores of Social Responsiveness Scale
Week 16
|
85.3 score on a scale
Standard Deviation 17.5
|
94.4 score on a scale
Standard Deviation 27.3
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12 and Week 16Population: The analysis sample excludes cases with low medication adherence and those who did not follow up as scheduled.
Repetitive Behavior Scale-Revised is a questionnaire that focuses on repetitive behavior. The score ranges from 0-129. The lower scores stand for lower repetitive behavior.
Outcome measures
| Measure |
PS128
n=19 Participants
Subjects will take PS128 capsules every day (2 capsules/day, once) for 12 weeks.
PS128: Each PS128 capsule contained \>3 × 10\^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg.
|
Placebo
n=17 Participants
Subjects will take placebo capsules every day (2 capsules/day, once) for 12 weeks.
Placebo: The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose.
|
Normal Control
Normal control group are enrolled by invitation from the age and gender matched healthy children.
|
|---|---|---|---|
|
Changes of Total Scores of Repetitive Behavior Scale-Revised
Week 16
|
25.7 score on a scale
Standard Deviation 20.7
|
28.5 score on a scale
Standard Deviation 21.4
|
—
|
|
Changes of Total Scores of Repetitive Behavior Scale-Revised
Baseline
|
30.6 score on a scale
Standard Deviation 20.7
|
33.7 score on a scale
Standard Deviation 22.8
|
—
|
|
Changes of Total Scores of Repetitive Behavior Scale-Revised
Week 12
|
26.4 score on a scale
Standard Deviation 21.6
|
30.2 score on a scale
Standard Deviation 22.8
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12 and Week 16Population: The analysis sample excludes cases with low medication adherence and those who did not follow up as scheduled.
Child Behavior Checklist is a parents' report questionnaire for behavioral and emotional problems. The score ranges from 0-240. The lower scores stand for better behavioral and emotional regulation.
Outcome measures
| Measure |
PS128
n=19 Participants
Subjects will take PS128 capsules every day (2 capsules/day, once) for 12 weeks.
PS128: Each PS128 capsule contained \>3 × 10\^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg.
|
Placebo
n=17 Participants
Subjects will take placebo capsules every day (2 capsules/day, once) for 12 weeks.
Placebo: The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose.
|
Normal Control
Normal control group are enrolled by invitation from the age and gender matched healthy children.
|
|---|---|---|---|
|
Changes of Total Scores of Child Behavior Checklist
Baseline
|
55.1 score on a scale
Standard Deviation 34.8
|
67.1 score on a scale
Standard Deviation 34.9
|
—
|
|
Changes of Total Scores of Child Behavior Checklist
Week 12
|
47.1 score on a scale
Standard Deviation 34.6
|
59.5 score on a scale
Standard Deviation 28.9
|
—
|
|
Changes of Total Scores of Child Behavior Checklist
Week 16
|
48.2 score on a scale
Standard Deviation 32.3
|
52.8 score on a scale
Standard Deviation 31.4
|
—
|
SECONDARY outcome
Timeframe: Baseline, week 12 and Week 16Population: The analysis sample excludes cases with low medication adherence and those who did not follow up as scheduled.
Adaptive Behavior Assessment System is a parents' report questionnaire for adaptive behavior. The score ranges from 9-171. The higher scores stand for better adaptive behavior.
Outcome measures
| Measure |
PS128
n=19 Participants
Subjects will take PS128 capsules every day (2 capsules/day, once) for 12 weeks.
PS128: Each PS128 capsule contained \>3 × 10\^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg.
|
Placebo
n=17 Participants
Subjects will take placebo capsules every day (2 capsules/day, once) for 12 weeks.
Placebo: The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose.
|
Normal Control
Normal control group are enrolled by invitation from the age and gender matched healthy children.
|
|---|---|---|---|
|
Changes of Total Scores of Adaptive Behavior Assessment System
Baseline
|
82.5 score on a scale
Standard Deviation 13.6
|
82.1 score on a scale
Standard Deviation 18.2
|
—
|
|
Changes of Total Scores of Adaptive Behavior Assessment System
week 12
|
86.1 score on a scale
Standard Deviation 15.5
|
81.3 score on a scale
Standard Deviation 18.1
|
—
|
|
Changes of Total Scores of Adaptive Behavior Assessment System
Week 16
|
83.5 score on a scale
Standard Deviation 14.9
|
86.0 score on a scale
Standard Deviation 17.7
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12 and Week 16Population: The analysis sample excludes cases with low medication adherence and those who did not follow up as scheduled.
A quick and objective test of Theory of Mind. 8 questions in total, the more correct questions stand for better Social Cognition.
Outcome measures
| Measure |
PS128
n=19 Participants
Subjects will take PS128 capsules every day (2 capsules/day, once) for 12 weeks.
PS128: Each PS128 capsule contained \>3 × 10\^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg.
|
Placebo
n=17 Participants
Subjects will take placebo capsules every day (2 capsules/day, once) for 12 weeks.
Placebo: The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose.
|
Normal Control
Normal control group are enrolled by invitation from the age and gender matched healthy children.
|
|---|---|---|---|
|
Changes in Accuracy of Frith-Happe Animation
Baseline
|
6.6 questions with correct responses
Standard Deviation 3.5
|
6.3 questions with correct responses
Standard Deviation 3.8
|
—
|
|
Changes in Accuracy of Frith-Happe Animation
Week 12
|
6.5 questions with correct responses
Standard Deviation 3.5
|
5.8 questions with correct responses
Standard Deviation 3.4
|
—
|
|
Changes in Accuracy of Frith-Happe Animation
Week 16
|
6.7 questions with correct responses
Standard Deviation 3.3
|
6.0 questions with correct responses
Standard Deviation 3.3
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12 and Week 16Population: The analysis sample excludes cases with low medication adherence and those who did not follow up as scheduled.
An advanced test for Theory of Mind. 43 questions in total, the more correct questions stand for better social skills.
Outcome measures
| Measure |
PS128
n=19 Participants
Subjects will take PS128 capsules every day (2 capsules/day, once) for 12 weeks.
PS128: Each PS128 capsule contained \>3 × 10\^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg.
|
Placebo
n=17 Participants
Subjects will take placebo capsules every day (2 capsules/day, once) for 12 weeks.
Placebo: The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose.
|
Normal Control
Normal control group are enrolled by invitation from the age and gender matched healthy children.
|
|---|---|---|---|
|
Changes in Accuracy of Eyes Task
Baseline
|
21.5 questions with correct responses
Standard Deviation 6.2
|
23.5 questions with correct responses
Standard Deviation 6.5
|
—
|
|
Changes in Accuracy of Eyes Task
Week 12
|
20.9 questions with correct responses
Standard Deviation 6.5
|
22.5 questions with correct responses
Standard Deviation 5.7
|
—
|
|
Changes in Accuracy of Eyes Task
Week 16
|
21.1 questions with correct responses
Standard Deviation 7.5
|
22.8 questions with correct responses
Standard Deviation 8.4
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12 and Week 16Population: The analysis sample excludes cases with low medication adherence and those who did not follow up as scheduled.
Aberrant Behavior Checklist is a parents' report questionnaire for aberrant behavior. The score ranges from 0-174. The lower scores stand for less aberrant behavior.
Outcome measures
| Measure |
PS128
n=19 Participants
Subjects will take PS128 capsules every day (2 capsules/day, once) for 12 weeks.
PS128: Each PS128 capsule contained \>3 × 10\^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg.
|
Placebo
n=17 Participants
Subjects will take placebo capsules every day (2 capsules/day, once) for 12 weeks.
Placebo: The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose.
|
Normal Control
Normal control group are enrolled by invitation from the age and gender matched healthy children.
|
|---|---|---|---|
|
Changes of Total Scores of Aberrant Behavior Checklist
Baseline
|
45.5 score on a scale
Standard Deviation 34.7
|
58.5 score on a scale
Standard Deviation 32.2
|
—
|
|
Changes of Total Scores of Aberrant Behavior Checklist
Week 12
|
36.2 score on a scale
Standard Deviation 33.3
|
47.2 score on a scale
Standard Deviation 32.8
|
—
|
|
Changes of Total Scores of Aberrant Behavior Checklist
Week 16
|
41.3 score on a scale
Standard Deviation 36.7
|
47.4 score on a scale
Standard Deviation 30.3
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12 and Week 16Population: The analysis sample excludes cases with low medication adherence and those who did not follow up as scheduled.
Emotional Dysregulation Inventory is a parents' report questionnaire for emotional dysregulation. The score ranges from 0-120. The lower scores stand for better emotional regulation.
Outcome measures
| Measure |
PS128
n=19 Participants
Subjects will take PS128 capsules every day (2 capsules/day, once) for 12 weeks.
PS128: Each PS128 capsule contained \>3 × 10\^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg.
|
Placebo
n=17 Participants
Subjects will take placebo capsules every day (2 capsules/day, once) for 12 weeks.
Placebo: The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose.
|
Normal Control
Normal control group are enrolled by invitation from the age and gender matched healthy children.
|
|---|---|---|---|
|
Changes of Total Scores of Emotional Dysregulation Inventory
Baseline
|
31.1 score on a scale
Standard Deviation 26.6
|
32.0 score on a scale
Standard Deviation 24.5
|
—
|
|
Changes of Total Scores of Emotional Dysregulation Inventory
Week 12
|
22.6 score on a scale
Standard Deviation 25.4
|
23.8 score on a scale
Standard Deviation 22.0
|
—
|
|
Changes of Total Scores of Emotional Dysregulation Inventory
Week 16
|
22.2 score on a scale
Standard Deviation 20.9
|
24.4 score on a scale
Standard Deviation 20.5
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12 and Week 16Population: The analysis sample excludes cases with low medication adherence and those who did not follow up as scheduled.
Parenting Stress Index is a parents' report questionnaire for parenting stress. The score ranges from 0-180. The lower scores stand for lower parenting stress.
Outcome measures
| Measure |
PS128
n=19 Participants
Subjects will take PS128 capsules every day (2 capsules/day, once) for 12 weeks.
PS128: Each PS128 capsule contained \>3 × 10\^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg.
|
Placebo
n=17 Participants
Subjects will take placebo capsules every day (2 capsules/day, once) for 12 weeks.
Placebo: The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose.
|
Normal Control
Normal control group are enrolled by invitation from the age and gender matched healthy children.
|
|---|---|---|---|
|
Changes of Total Scores of Parenting Stress Index, Fourth Editon
Baseline
|
99.6 score on a scale
Standard Deviation 19.8
|
98.7 score on a scale
Standard Deviation 24.8
|
—
|
|
Changes of Total Scores of Parenting Stress Index, Fourth Editon
Week 12
|
100.1 score on a scale
Standard Deviation 21.2
|
100.5 score on a scale
Standard Deviation 20.9
|
—
|
|
Changes of Total Scores of Parenting Stress Index, Fourth Editon
Week 16
|
102.2 score on a scale
Standard Deviation 21.8
|
97.4 score on a scale
Standard Deviation 24.2
|
—
|
SECONDARY outcome
Timeframe: Week 12 and Week 16Population: The analysis sample excludes cases with low medication adherence and those who did not follow up as scheduled.
The Clinical Global Impression (CGI) is a clinician rated measure of illness severity, improvement, and efficacy of treatment. The CGI-I is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. The score ranges from 1-7. CGI Improvement scale: 1=very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; 7=Very much worse.
Outcome measures
| Measure |
PS128
n=19 Participants
Subjects will take PS128 capsules every day (2 capsules/day, once) for 12 weeks.
PS128: Each PS128 capsule contained \>3 × 10\^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg.
|
Placebo
n=17 Participants
Subjects will take placebo capsules every day (2 capsules/day, once) for 12 weeks.
Placebo: The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose.
|
Normal Control
Normal control group are enrolled by invitation from the age and gender matched healthy children.
|
|---|---|---|---|
|
Assessment of Clinical Global Impression-Severity of Illness
Week 12
|
3.9 score on a scale
Standard Deviation 0.6
|
3.9 score on a scale
Standard Deviation 0.6
|
—
|
|
Assessment of Clinical Global Impression-Severity of Illness
Week 16
|
4.1 score on a scale
Standard Deviation 0.5
|
4.1 score on a scale
Standard Deviation 0.6
|
—
|
SECONDARY outcome
Timeframe: Week 12 and Week 16Population: The analysis sample excludes cases with low medication adherence and those who did not follow up as scheduled.
The self-report measure Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment. PGIC is a 7 point scale depicting a patient's rating of overall improvement. The score ranges from 1-7. Patients rate their change as "1=very much improved ," "2=much improved," "3=minimally improved," "4=no change," "5=minimally worse," "6=much worse," or "7=very much worse)."
Outcome measures
| Measure |
PS128
n=19 Participants
Subjects will take PS128 capsules every day (2 capsules/day, once) for 12 weeks.
PS128: Each PS128 capsule contained \>3 × 10\^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg.
|
Placebo
n=17 Participants
Subjects will take placebo capsules every day (2 capsules/day, once) for 12 weeks.
Placebo: The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose.
|
Normal Control
Normal control group are enrolled by invitation from the age and gender matched healthy children.
|
|---|---|---|---|
|
Assessment of Patient Global Impression of Change
Week 12
|
3.4 score on a scale
Standard Deviation 0.9
|
3.5 score on a scale
Standard Deviation 0.9
|
—
|
|
Assessment of Patient Global Impression of Change
Week 16
|
3.3 score on a scale
Standard Deviation 1.1
|
3.1 score on a scale
Standard Deviation 1.2
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: One participant was excluded from the analysis due to incomplete data.
Collect the DNA of fecal flora to test the diversity and abundance of gut microbiota as well as short chain fatty acids in Stool samples. The 16S rRNA gene amplicons will be prepared following the Illumina protocol for preparing the 16S metagenomic sequencing library. Values represent percentages and range from 0 to 100%, with higher values indicating a higher relative abundance of the target bacterium in the gut microbiota
Outcome measures
| Measure |
PS128
n=18 Participants
Subjects will take PS128 capsules every day (2 capsules/day, once) for 12 weeks.
PS128: Each PS128 capsule contained \>3 × 10\^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg.
|
Placebo
n=17 Participants
Subjects will take placebo capsules every day (2 capsules/day, once) for 12 weeks.
Placebo: The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose.
|
Normal Control
Normal control group are enrolled by invitation from the age and gender matched healthy children.
|
|---|---|---|---|
|
Gut Microbiota-Relative Abundance of Bifidobacterium Faecale
Baseline
|
0.34 percentage of Bifidobacterium faecale
Standard Deviation 0.60
|
0.55 percentage of Bifidobacterium faecale
Standard Deviation 1.31
|
—
|
|
Gut Microbiota-Relative Abundance of Bifidobacterium Faecale
Week 12
|
0.99 percentage of Bifidobacterium faecale
Standard Deviation 1.53
|
0.32 percentage of Bifidobacterium faecale
Standard Deviation 0.92
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Brain structural volumes (cm²). The advanced processing and analysis of the MRI data have been outsourced to an external core facility. Due to resource scheduling and the prolonged timeline required for specialized image preprocessing, the data analysis is currently in progress and has not yet been finalized. Therefore, quantifiable results are unavailable for summary in the data table at this time.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 12Blood-oxygen-level-dependent (BOLD) signal is a measurement used in fMRI, which reflects the neural activity. The advanced processing and analysis of the MRI data have been outsourced to an external core facility. Due to resource scheduling and the prolonged timeline required for specialized image preprocessing, the data analysis is currently in progress and has not yet been finalized. Therefore, quantifiable results are unavailable for summary in the data table at this time.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 12Fractional anisotropy (FA) is a measurement used in DTI, which reflects the movement of water molecules. FA ranges from 0 to 1, the higher FA value may represent more intact axons. The advanced processing and analysis of the MRI data have been outsourced to an external core facility. Due to resource scheduling and the prolonged timeline required for specialized image preprocessing, the data analysis is currently in progress and has not yet been finalized. Therefore, quantifiable results are unavailable for summary in the data table at this time.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The analysis sample excludes cases with low medication adherence and those who did not follow up as scheduled.
Safety is assessed function of liver and kidney such as albumin (3.5-5.4 g/dl).
Outcome measures
| Measure |
PS128
n=19 Participants
Subjects will take PS128 capsules every day (2 capsules/day, once) for 12 weeks.
PS128: Each PS128 capsule contained \>3 × 10\^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg.
|
Placebo
n=16 Participants
Subjects will take placebo capsules every day (2 capsules/day, once) for 12 weeks.
Placebo: The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose.
|
Normal Control
Normal control group are enrolled by invitation from the age and gender matched healthy children.
|
|---|---|---|---|
|
Safety Assessment - Albumin
Baseline
|
4.7 g/dl
Standard Deviation 0.2
|
4.7 g/dl
Standard Deviation 0.2
|
—
|
|
Safety Assessment - Albumin
Week 12
|
4.6 g/dl
Standard Deviation 0.2
|
4.7 g/dl
Standard Deviation 0.2
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The analysis sample excludes cases with low medication adherence and those who did not follow up as scheduled.
Safety is assessed function of liver and kidney such as total protein (6.4-8.3 g/dl).
Outcome measures
| Measure |
PS128
n=19 Participants
Subjects will take PS128 capsules every day (2 capsules/day, once) for 12 weeks.
PS128: Each PS128 capsule contained \>3 × 10\^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg.
|
Placebo
n=16 Participants
Subjects will take placebo capsules every day (2 capsules/day, once) for 12 weeks.
Placebo: The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose.
|
Normal Control
Normal control group are enrolled by invitation from the age and gender matched healthy children.
|
|---|---|---|---|
|
Safety Assessment - Total Protein
Baseline
|
7.2 g/dl
Standard Deviation 0.3
|
7.3 g/dl
Standard Deviation 0.4
|
—
|
|
Safety Assessment - Total Protein
Week 12
|
7.2 g/dl
Standard Deviation 0.3
|
7.3 g/dl
Standard Deviation 0.3
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The analysis sample excludes cases with low medication adherence and those who did not follow up as scheduled.
Safety is assessed function of liver and kidney such as ALP (135-320 U/L).
Outcome measures
| Measure |
PS128
n=19 Participants
Subjects will take PS128 capsules every day (2 capsules/day, once) for 12 weeks.
PS128: Each PS128 capsule contained \>3 × 10\^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg.
|
Placebo
n=16 Participants
Subjects will take placebo capsules every day (2 capsules/day, once) for 12 weeks.
Placebo: The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose.
|
Normal Control
Normal control group are enrolled by invitation from the age and gender matched healthy children.
|
|---|---|---|---|
|
Safety Assessment - ALP
Baseline
|
218.2 U/L
Standard Deviation 50.5
|
244.9 U/L
Standard Deviation 73.9
|
—
|
|
Safety Assessment - ALP
Week 12
|
214.9 U/L
Standard Deviation 52.1
|
241.8 U/L
Standard Deviation 64.1
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The analysis sample excludes cases with low medication adherence and those who did not follow up as scheduled.
Safety is assessed function of liver and kidney such as total bilirubin (0.3-1.2 mg/dl).
Outcome measures
| Measure |
PS128
n=19 Participants
Subjects will take PS128 capsules every day (2 capsules/day, once) for 12 weeks.
PS128: Each PS128 capsule contained \>3 × 10\^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg.
|
Placebo
n=16 Participants
Subjects will take placebo capsules every day (2 capsules/day, once) for 12 weeks.
Placebo: The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose.
|
Normal Control
Normal control group are enrolled by invitation from the age and gender matched healthy children.
|
|---|---|---|---|
|
Safety Assessment - Total Bilirubin
Baseline
|
0.4 mg/dl
Standard Deviation 0.1
|
0.4 mg/dl
Standard Deviation 0.2
|
—
|
|
Safety Assessment - Total Bilirubin
Week 12
|
0.3 mg/dl
Standard Deviation 0.1
|
0.5 mg/dl
Standard Deviation 0.2
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The analysis sample excludes cases with low medication adherence and those who did not follow up as scheduled.
Safety is assessed function of liver and kidney such as T-Cholesterol (\<170 mg/dL).
Outcome measures
| Measure |
PS128
n=19 Participants
Subjects will take PS128 capsules every day (2 capsules/day, once) for 12 weeks.
PS128: Each PS128 capsule contained \>3 × 10\^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg.
|
Placebo
n=16 Participants
Subjects will take placebo capsules every day (2 capsules/day, once) for 12 weeks.
Placebo: The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose.
|
Normal Control
Normal control group are enrolled by invitation from the age and gender matched healthy children.
|
|---|---|---|---|
|
Safety Assessment - T-Cholesterol
Baseline
|
177.3 mg/dL
Standard Deviation 24.1
|
163.1 mg/dL
Standard Deviation 15.2
|
—
|
|
Safety Assessment - T-Cholesterol
Week 12
|
175.8 mg/dL
Standard Deviation 26.5
|
163.3 mg/dL
Standard Deviation 20.2
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The analysis sample excludes cases with low medication adherence and those who did not follow up as scheduled.
Safety is assessed function of liver and kidney such as uric acid (\<7.0 mg/dl).
Outcome measures
| Measure |
PS128
n=19 Participants
Subjects will take PS128 capsules every day (2 capsules/day, once) for 12 weeks.
PS128: Each PS128 capsule contained \>3 × 10\^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg.
|
Placebo
n=16 Participants
Subjects will take placebo capsules every day (2 capsules/day, once) for 12 weeks.
Placebo: The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose.
|
Normal Control
Normal control group are enrolled by invitation from the age and gender matched healthy children.
|
|---|---|---|---|
|
Safety Assessment - Uric Acid
Baseline
|
4.0 mg/dl
Standard Deviation 1.1
|
4.4 mg/dl
Standard Deviation 1.2
|
—
|
|
Safety Assessment - Uric Acid
Week 12
|
4.0 mg/dl
Standard Deviation 0.9
|
4.6 mg/dl
Standard Deviation 1.5
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The analysis sample excludes cases with low medication adherence and those who did not follow up as scheduled.
Safety is assessed function of liver and kidney such as BUN (7-25 mg/dl).
Outcome measures
| Measure |
PS128
n=19 Participants
Subjects will take PS128 capsules every day (2 capsules/day, once) for 12 weeks.
PS128: Each PS128 capsule contained \>3 × 10\^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg.
|
Placebo
n=16 Participants
Subjects will take placebo capsules every day (2 capsules/day, once) for 12 weeks.
Placebo: The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose.
|
Normal Control
Normal control group are enrolled by invitation from the age and gender matched healthy children.
|
|---|---|---|---|
|
Safety Assessment - BUN
Baseline
|
13.7 mg/dl
Standard Deviation 2.8
|
14.3 mg/dl
Standard Deviation 2.4
|
—
|
|
Safety Assessment - BUN
Week 12
|
13.3 mg/dl
Standard Deviation 2.6
|
13.1 mg/dl
Standard Deviation 3.1
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The analysis sample excludes cases with low medication adherence and those who did not follow up as scheduled.
Safety is assessed function of liver and kidney such as creatinine (0.2-1.0 mg/dl).
Outcome measures
| Measure |
PS128
n=19 Participants
Subjects will take PS128 capsules every day (2 capsules/day, once) for 12 weeks.
PS128: Each PS128 capsule contained \>3 × 10\^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg.
|
Placebo
n=16 Participants
Subjects will take placebo capsules every day (2 capsules/day, once) for 12 weeks.
Placebo: The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose.
|
Normal Control
Normal control group are enrolled by invitation from the age and gender matched healthy children.
|
|---|---|---|---|
|
Safety Assessment - Creatinine
Baseline
|
0.4 mg/dl
Standard Deviation 0.1
|
0.4 mg/dl
Standard Deviation 0.1
|
—
|
|
Safety Assessment - Creatinine
Week 12
|
0.4 mg/dl
Standard Deviation 0.1
|
0.4 mg/dl
Standard Deviation 0.1
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The analysis sample excludes cases with low medication adherence and those who did not follow up as scheduled.
Safety is assessed function of liver and kidney such as AST (13-40 U/L).
Outcome measures
| Measure |
PS128
n=19 Participants
Subjects will take PS128 capsules every day (2 capsules/day, once) for 12 weeks.
PS128: Each PS128 capsule contained \>3 × 10\^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg.
|
Placebo
n=16 Participants
Subjects will take placebo capsules every day (2 capsules/day, once) for 12 weeks.
Placebo: The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose.
|
Normal Control
Normal control group are enrolled by invitation from the age and gender matched healthy children.
|
|---|---|---|---|
|
Safety Assessment - AST
Baseline
|
21.2 U/L
Standard Deviation 3.6
|
23.4 U/L
Standard Deviation 7.1
|
—
|
|
Safety Assessment - AST
Week 12
|
20.9 U/L
Standard Deviation 4.5
|
22.4 U/L
Standard Deviation 7.7
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The analysis sample excludes cases with low medication adherence and those who did not follow up as scheduled.
Safety is assessed function of liver and kidney such as ALT (7-40 U/L).
Outcome measures
| Measure |
PS128
n=19 Participants
Subjects will take PS128 capsules every day (2 capsules/day, once) for 12 weeks.
PS128: Each PS128 capsule contained \>3 × 10\^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg.
|
Placebo
n=16 Participants
Subjects will take placebo capsules every day (2 capsules/day, once) for 12 weeks.
Placebo: The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose.
|
Normal Control
Normal control group are enrolled by invitation from the age and gender matched healthy children.
|
|---|---|---|---|
|
Safety Assessment - ALT
Baseline
|
14.2 U/L
Standard Deviation 7.6
|
21.1 U/L
Standard Deviation 12.8
|
—
|
|
Safety Assessment - ALT
Week 12
|
14.0 U/L
Standard Deviation 4.9
|
19.1 U/L
Standard Deviation 8.6
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: During COVID-19, study execution and compliance were heavily impacted. Blood collection in children with ASD was highly challenging due to low tolerance for repeated venipunctures. While other planned measures were successfully completed, these specific exploratory biomarker analyses (MPO, IL-1β, TGF-β1, Eotaxin, IL-6) were not performed. The study was formally approved for closure on Feb 10, 2025; no future analyses for these uncollected biomarkers will be conducted.
Inflammatory is assessed via a composite measure of circulating cytokines - MPO (ng/mL)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 12Population: During COVID-19, study execution and compliance were heavily impacted. Blood collection in children with ASD was highly challenging due to low tolerance for repeated venipunctures. While other planned measures were successfully completed, these specific exploratory biomarker analyses (MPO, IL-1β, TGF-β1, Eotaxin, IL-6) were not performed. The study was formally approved for closure on Feb 10, 2025; no future analyses for these uncollected biomarkers will be conducted.
Inflammatory is assessed via a composite measure of circulating cytokines - IL-1β (pg/mL)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 12Population: During COVID-19, study execution and compliance were heavily impacted. Blood collection in children with ASD was highly challenging due to low tolerance for repeated venipunctures. While other planned measures were successfully completed, these specific exploratory biomarker analyses (MPO, IL-1β, TGF-β1, Eotaxin, IL-6) were not performed. The study was formally approved for closure on Feb 10, 2025; no future analyses for these uncollected biomarkers will be conducted.
Inflammatory is assessed via a composite measure of circulating cytokines - TGF-β1 (pg/mL)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 12Population: During COVID-19, study execution and compliance were heavily impacted. Blood collection in children with ASD was highly challenging due to low tolerance for repeated venipunctures. While other planned measures were successfully completed, these specific exploratory biomarker analyses (MPO, IL-1β, TGF-β1, Eotaxin, IL-6) were not performed. The study was formally approved for closure on Feb 10, 2025; no future analyses for these uncollected biomarkers will be conducted.
Inflammatory is assessed via a composite measure of circulating cytokines - Eotaxin (pg/mL)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 12Population: During COVID-19, study execution and compliance were heavily impacted. Blood collection in children with ASD was highly challenging due to low tolerance for repeated venipunctures. While other planned measures were successfully completed, these specific exploratory biomarker analyses (MPO, IL-1β, TGF-β1, Eotaxin, IL-6) were not performed. The study was formally approved for closure on Feb 10, 2025; no future analyses for these uncollected biomarkers will be conducted.
Inflammatory is assessed via a composite measure of circulating cytokines - IL-6 (ng/mL)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The analysis sample excludes cases with low medication adherence and those who did not follow up as scheduled.
Oxidative stress is assessed via Serotonin (ng/mL).
Outcome measures
| Measure |
PS128
n=19 Participants
Subjects will take PS128 capsules every day (2 capsules/day, once) for 12 weeks.
PS128: Each PS128 capsule contained \>3 × 10\^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg.
|
Placebo
n=16 Participants
Subjects will take placebo capsules every day (2 capsules/day, once) for 12 weeks.
Placebo: The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose.
|
Normal Control
Normal control group are enrolled by invitation from the age and gender matched healthy children.
|
|---|---|---|---|
|
Change in Levels of Exploratory Blood-based Biomarkers for Oxidative Stress Changes - Serotonin
Baseline
|
43.1 ng/mL
Standard Deviation 45.1
|
34.4 ng/mL
Standard Deviation 19.1
|
—
|
|
Change in Levels of Exploratory Blood-based Biomarkers for Oxidative Stress Changes - Serotonin
Week 12
|
45.9 ng/mL
Standard Deviation 32.2
|
56.4 ng/mL
Standard Deviation 41.7
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The analysis sample excludes cases with low medication adherence and those who did not follow up as scheduled.
Oxidative stress is assessed via GABA (μmol/L).
Outcome measures
| Measure |
PS128
n=19 Participants
Subjects will take PS128 capsules every day (2 capsules/day, once) for 12 weeks.
PS128: Each PS128 capsule contained \>3 × 10\^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg.
|
Placebo
n=16 Participants
Subjects will take placebo capsules every day (2 capsules/day, once) for 12 weeks.
Placebo: The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose.
|
Normal Control
Normal control group are enrolled by invitation from the age and gender matched healthy children.
|
|---|---|---|---|
|
Change in Levels of Exploratory Blood-based Biomarkers for Oxidative Stress Changes - GABA
Baseline
|
3.8 μmol/L
Standard Deviation 0.1
|
3.8 μmol/L
Standard Deviation 0.1
|
—
|
|
Change in Levels of Exploratory Blood-based Biomarkers for Oxidative Stress Changes - GABA
Week 12
|
3.7 μmol/L
Standard Deviation 0.1
|
3.8 μmol/L
Standard Deviation 0.3
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The analysis sample excludes cases with low medication adherence and those who did not follow up as scheduled.
Oxidative stress is assessed via Cortisol (6-10am 4.82-19.5, 4-8pm 2.47-11.9, μg/dl).
Outcome measures
| Measure |
PS128
n=19 Participants
Subjects will take PS128 capsules every day (2 capsules/day, once) for 12 weeks.
PS128: Each PS128 capsule contained \>3 × 10\^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg.
|
Placebo
n=16 Participants
Subjects will take placebo capsules every day (2 capsules/day, once) for 12 weeks.
Placebo: The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose.
|
Normal Control
Normal control group are enrolled by invitation from the age and gender matched healthy children.
|
|---|---|---|---|
|
Change in Levels of Exploratory Blood-based Biomarkers for Oxidative Stress Changes - Cortisol
Baseline
|
7.1 μg/dl
Standard Deviation 5.6
|
6.0 μg/dl
Standard Deviation 3.1
|
—
|
|
Change in Levels of Exploratory Blood-based Biomarkers for Oxidative Stress Changes - Cortisol
Week 12
|
6.5 μg/dl
Standard Deviation 4.6
|
5.5 μg/dl
Standard Deviation 3.2
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: One participant was excluded from the analysis due to incomplete data.
Collect the DNA of fecal flora to test the diversity and abundance of gut microbiota as well as short chain fatty acids in Stool samples. The 16S rRNA gene amplicons will be prepared following the Illumina protocol for preparing the 16S metagenomic sequencing library. Values represent percentages and range from 0 to 100%, with higher values indicating a higher relative abundance of the target bacterium in the gut microbiota.
Outcome measures
| Measure |
PS128
n=18 Participants
Subjects will take PS128 capsules every day (2 capsules/day, once) for 12 weeks.
PS128: Each PS128 capsule contained \>3 × 10\^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg.
|
Placebo
n=17 Participants
Subjects will take placebo capsules every day (2 capsules/day, once) for 12 weeks.
Placebo: The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose.
|
Normal Control
Normal control group are enrolled by invitation from the age and gender matched healthy children.
|
|---|---|---|---|
|
Gut Microbiota-Relative Abundance of Lactiplantibacillus Plantarum
Baseline
|
0.00 percentage of Lactiplantibacillus
Standard Deviation 0.00
|
0.00 percentage of Lactiplantibacillus
Standard Deviation 0.00
|
—
|
|
Gut Microbiota-Relative Abundance of Lactiplantibacillus Plantarum
Week 12
|
0.80 percentage of Lactiplantibacillus
Standard Deviation 1.03
|
0.00 percentage of Lactiplantibacillus
Standard Deviation 0.00
|
—
|
Adverse Events
PS128
Placebo
Normal Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place