Trial Outcomes & Findings for Effects of Sacrosidase and Placebo in Subjects With Fructan Intolerance (NCT NCT05703009)
NCT ID: NCT05703009
Last Updated: 2026-06-30
Results Overview
The numeric value of the Total Symptom Score (TSS) is derived from the Daily Symptom Questionnaire (DSQ). The DSQ consisted of rating the frequency in the last 24 hours and the severity of 7 symptoms, abdominal bloating, abdominal pain, abdominal cramps, abdominal gas/flatulence, constipation, nausea, and diarrhea. The daily symptom score is calculated by summing the frequency and severity scores for each symptom with a minimum daily score of 0 and a maximum daily score of 98. The TSS is calculated by averaging the combined daily symptom scores during a 7-day period for baseline and 1-week post-intervention during each treatment period and ranges from 0-98, with higher values representing a worse outcome.
COMPLETED
PHASE2
25 participants
Baseline and 1 week
2026-06-30
Participant Flow
Participant milestones
| Measure |
Sacrosidase, 2 ,L (17,000 IU), Then Placebo
Subjects randomized to take active treatment, sacrosidase, 2 mL (17,000 IU) with every meal or snack, administered orally following dilution with 2 to 4 ounces (60 to 120 mL) of water or milk (either cold or at room temperature) for one week.
|
Placebo, Then Sacrosidase 2 mL (17,000 IU)
Subjects randomized to take placebo treatment, sacrosidase placebo, 2 mL (17,000 IU) with every meal or snack, administered orally following dilution with 2 to 4 ounces (60 to 120 mL) of water or milk (either cold or at room temperature) for one week.
|
|---|---|---|
|
Treatment Period 1 (1 week)
STARTED
|
12
|
13
|
|
Treatment Period 1 (1 week)
COMPLETED
|
12
|
13
|
|
Treatment Period 1 (1 week)
NOT COMPLETED
|
0
|
0
|
|
Washout Period (1 week)
STARTED
|
12
|
13
|
|
Washout Period (1 week)
COMPLETED
|
12
|
13
|
|
Washout Period (1 week)
NOT COMPLETED
|
0
|
0
|
|
Treatment Period 2 (1 week)
STARTED
|
12
|
13
|
|
Treatment Period 2 (1 week)
COMPLETED
|
12
|
13
|
|
Treatment Period 2 (1 week)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Sacrosidase and Placebo in Subjects With Fructan Intolerance
Baseline characteristics by cohort
| Measure |
Sacrosidase 2 mL (17,000 IU), Then Placebo
n=12 Participants
Subjects randomized to take active treatment, sacrosidase oral solution 17,000 IU with every meal or snack, administered orally following dilution with 2 to 4 ounces (60 to 120 mL) of water or milk (either cold or at room temperature) for one week. After a 1-week wash-out period, subjects received placebo (matching active sacrosidase 17,000 IU) for 1 week with every meal or snack.
|
Placebo, Then Sacrosidase 2 mL (17,000 IU)
n=13 Participants
Subjects randomized to take placebo matching sacrosidase 17,000 IU, with every meal or snack, administered orally following dilution with 2 to 4 ounces (60 to 120 mL) of water or milk (either cold or at room temperature) for one week. After a 1-week wash-out period, subjects received active sacrosidase oral solution 17,000 IU with every meal or snack.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=20 Participants
|
13 Participants
n=20 Participants
|
25 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Continuous
|
36.3 years
STANDARD_DEVIATION 10.31 • n=20 Participants
|
35.8 years
STANDARD_DEVIATION 11.48 • n=20 Participants
|
36.0 years
STANDARD_DEVIATION 10.71 • n=40 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
17 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=20 Participants
|
12 Participants
n=20 Participants
|
24 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
21 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=20 Participants
|
13 participants
n=20 Participants
|
25 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Baseline and 1 weekThe numeric value of the Total Symptom Score (TSS) is derived from the Daily Symptom Questionnaire (DSQ). The DSQ consisted of rating the frequency in the last 24 hours and the severity of 7 symptoms, abdominal bloating, abdominal pain, abdominal cramps, abdominal gas/flatulence, constipation, nausea, and diarrhea. The daily symptom score is calculated by summing the frequency and severity scores for each symptom with a minimum daily score of 0 and a maximum daily score of 98. The TSS is calculated by averaging the combined daily symptom scores during a 7-day period for baseline and 1-week post-intervention during each treatment period and ranges from 0-98, with higher values representing a worse outcome.
Outcome measures
| Measure |
Sacrosidase 2 mL (17,000 IU)
n=25 Participants
Subjects who received sacrosidase oral solution, 2 mL (17,000 IU) with every meal or snack, administered orally following dilution with 2 to 4 ounces (60 to 120 mL) of water or milk (either cold or at room temperature) for 1 week during Treatment Period 1 or Treatment Period 2.
|
Placebo
n=25 Participants
Subjects who received Placebo (matching sacrosidase oral solution) with every meal or snack, administered orally following dilution with 2 to 4 ounces (60 to 120 mL) of water or milk (either cold or at room temperature) for 1 week during Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Change From Baseline in Mean (SD) Total Symptom Score (TSS) at 1 Week
|
-4.11 units on a scale
Standard Deviation 10.736
|
-2.88 units on a scale
Standard Deviation 8.421
|
SECONDARY outcome
Timeframe: Baseline and 1 weekThe Daily Symptom Questionnaire (DSQ) consisted of rating the frequency in the last 24 hours and the severity of 7 symptoms, abdominal bloating, abdominal pain, abdominal cramps, abdominal gas/flatulence, constipation, nausea, and diarrhea. The frequency score for abdominal bloating experienced is calculated by averaging the combined daily scores during a 7-day period for baseline and 1-week post-intervention during each treatment period and ranges from 0-5, with higher values representing a worse outcome.
Outcome measures
| Measure |
Sacrosidase 2 mL (17,000 IU)
n=25 Participants
Subjects who received sacrosidase oral solution, 2 mL (17,000 IU) with every meal or snack, administered orally following dilution with 2 to 4 ounces (60 to 120 mL) of water or milk (either cold or at room temperature) for 1 week during Treatment Period 1 or Treatment Period 2.
|
Placebo
n=25 Participants
Subjects who received Placebo (matching sacrosidase oral solution) with every meal or snack, administered orally following dilution with 2 to 4 ounces (60 to 120 mL) of water or milk (either cold or at room temperature) for 1 week during Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Change From Baseline in Mean (SD) Frequency Score for Abdominal Bloating From Baseline to 1 Week
|
-0.50 score on a scale
Standard Deviation 1.058
|
-0.54 score on a scale
Standard Deviation 0.990
|
Adverse Events
Sacrosidase 2 mL (17,000 IU)
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sacrosidase 2 mL (17,000 IU)
n=25 participants at risk
Subjects who received sacrosidase oral solution, 2 mL (17,000 IU) with every meal or snack, administered orally following dilution with 2 to 4 ounces (60 to 120 mL) of water or milk (either cold or at room temperature) for 1 week during Treatment Period 1 or Treatment Period 2.
|
Placebo
n=25 participants at risk
Subjects who received Placebo (matching sacrosidase oral solution) with every meal or snack, administered orally following dilution with 2 to 4 ounces (60 to 120 mL) of water or milk (either cold or at room temperature) for 1 week during Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/25 • 1 week for each intervention
|
4.0%
1/25 • 1 week for each intervention
|
|
Gastrointestinal disorders
Worsened Gastroparesis
|
0.00%
0/25 • 1 week for each intervention
|
4.0%
1/25 • 1 week for each intervention
|
|
Reproductive system and breast disorders
Heavy Menstrual Bleeding
|
0.00%
0/25 • 1 week for each intervention
|
4.0%
1/25 • 1 week for each intervention
|
|
Infections and infestations
Food Poisoning
|
4.0%
1/25 • 1 week for each intervention
|
0.00%
0/25 • 1 week for each intervention
|
|
Skin and subcutaneous tissue disorders
Lipoma
|
4.0%
1/25 • 1 week for each intervention
|
0.00%
0/25 • 1 week for each intervention
|
|
Gastrointestinal disorders
Acid Reflux
|
4.0%
1/25 • 1 week for each intervention
|
0.00%
0/25 • 1 week for each intervention
|
Additional Information
Kasidy Street, Senior Clinical Project Manager & Medical Information Specialist
QOL Medical
Results disclosure agreements
- Principal investigator is a sponsor employee As outlined in each Clinical Trial Agreement between Sponsor and PI.
- Publication restrictions are in place
Restriction type: OTHER