Trial Outcomes & Findings for SH-DS01 on Fecal Metagenomic Stability (NCT NCT04598295)
NCT ID: NCT04598295
Last Updated: 2026-02-17
Results Overview
measure of reported adverse events during the study period
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
12 weeks
Results posted on
2026-02-17
Participant Flow
Participant milestones
| Measure |
Microbial Consortia (DS-01)
DS-01 is a rationally defined microbial consortia consisting of 24 strains across 12 species, with polyphenolic and phenolic prebiotic bioactive compounds. Participants will be instructed to take 2 capsules daily for the duration of the trial.
DS-01: synbiotic
|
Placebo
Placebo capsules for DS-01 will contain rice flour matched for color and texture in an identical outer capsule shell. Participants will be instructed to take 2 capsules daily for the duration of the trial.
DS-01: synbiotic
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
|
Overall Study
COMPLETED
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SH-DS01 on Fecal Metagenomic Stability
Baseline characteristics by cohort
| Measure |
Microbial Consortia (DS-01)
n=24 Participants
DS-01 is a rationally defined microbial consortia consisting of 24 strains across 12 species, with polyphenolic and phenolic prebiotic bioactive compounds. Participants will be instructed to take 2 capsules daily for the duration of the trial.
DS-01: synbiotic
|
Placebo
n=24 Participants
Placebo capsules for DS-01 will contain rice flour matched for color and texture in an identical outer capsule shell. Participants will be instructed to take 2 capsules daily for the duration of the trial.
DS-01: synbiotic
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29 years
STANDARD_DEVIATION 8 • n=25 Participants
|
28.8 years
STANDARD_DEVIATION 7.9 • n=20 Participants
|
28.9 years
STANDARD_DEVIATION 8 • n=45 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=25 Participants
|
21 Participants
n=20 Participants
|
42 Participants
n=45 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=25 Participants
|
3 Participants
n=20 Participants
|
6 Participants
n=45 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=25 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=25 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=25 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=25 Participants
|
22 Participants
n=20 Participants
|
44 Participants
n=45 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=25 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=45 Participants
|
|
IBS-M
|
17 participants
n=25 Participants
|
15 participants
n=20 Participants
|
32 participants
n=45 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: subjects who received DS-01 or matching placebo
measure of reported adverse events during the study period
Outcome measures
| Measure |
Microbial Consortia (DS-01)
n=24 Participants
DS-01 is a rationally defined microbial consortia consisting of 24 strains across 12 species, with polyphenolic and phenolic prebiotic bioactive compounds. Participants will be instructed to take 2 capsules daily for the duration of the trial.
DS-01: synbiotic
|
Placebo
n=24 Participants
Placebo capsules for DS-01 will contain rice flour matched for color and texture in an identical outer capsule shell. Participants will be instructed to take 2 capsules daily for the duration of the trial.
DS-01: synbiotic
|
|---|---|---|
|
Safety and Tolerability of DS-01 Treatment vs Placebo
|
0 Participants
|
0 Participants
|
Adverse Events
Microbial Consortia (DS-01)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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