Trial Outcomes & Findings for The Role of Fiber in the Prevention and Treatment of Fecal Incontinence (NCT NCT04806386)
NCT ID: NCT04806386
Last Updated: 2026-06-30
Results Overview
The Shannon Diversity Index is a measure of within-sample microbial diversity that incorporates both the number of microbial taxa present (i.e., richness) and the distribution of their relative abundances (i.e., evenness). It is calculated using the relative abundance of observed taxa within each stool sample. Higher values indicate greater microbial diversity. The theoretical minimum value is 0, and there is no fixed theoretical maximum because the upper bound depends on the number of taxa detected in a sample and sequencing depth. In human gut microbiome studies, observed values commonly range from approximately 2 to 6.
COMPLETED
NA
31 participants
Change from baseline to final visit. Through study completion, up to 6 weeks.
2026-06-30
Participant Flow
Participant milestones
| Measure |
Psyllium Fiber Supplement Treatment
All patients will receive psyllium fiber in the form of edible bars, 7g, twice a day to total 14g per day.
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|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Psyllium Fiber Supplement Treatment
All patients will receive psyllium fiber in the form of edible bars, 7g, twice a day to total 14g per day.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
One participant did not complete the trial and therefore, their data was not analyzed.
Baseline characteristics by cohort
| Measure |
Psyllium Fiber Supplement Treatment
n=31 Participants
All patients will receive psyllium fiber in the form of edible bars, 7g, twice a day to total 14g per day.
Psyllium: Psyllium fiber powder baked into a bar is commonly used as a first line of treatment for patients with fecal incontinence.
|
|---|---|
|
Age, Continuous
|
68.89 Years
STANDARD_DEVIATION 7.25 • n=20 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=20 Participants • One participant did not complete the trial and therefore, their data was not analyzed.
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants • One participant did not complete the trial and therefore, their data was not analyzed.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
31 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to final visit. Through study completion, up to 6 weeks.Population: 1 Participant did not complete the study due to side effects from fiber bar consumption.
The Shannon Diversity Index is a measure of within-sample microbial diversity that incorporates both the number of microbial taxa present (i.e., richness) and the distribution of their relative abundances (i.e., evenness). It is calculated using the relative abundance of observed taxa within each stool sample. Higher values indicate greater microbial diversity. The theoretical minimum value is 0, and there is no fixed theoretical maximum because the upper bound depends on the number of taxa detected in a sample and sequencing depth. In human gut microbiome studies, observed values commonly range from approximately 2 to 6.
Outcome measures
| Measure |
Psyllium Fiber Supplement Treatment
n=30 Participants
All patients will receive psyllium fiber in the form of edible bars, 7g, twice a day to total 14g per day.
Psyllium: Psyllium fiber powder baked into a bar is commonly used as a first line of treatment for patients with fecal incontinence.
|
|---|---|
|
Change in Stool Metagenomics Assessed by Sequence-based Microbial Communities and Rare Taxa
|
-0.329 Shannon Diversity Index
Interval -0.479 to -0.178
|
PRIMARY outcome
Timeframe: Change from baseline to final visit. Through study completion, up to 6 weeks.Population: 1 Participant did not complete the study due to side effects from fiber bar consumption.
Butyrate was measured in stool samples using untargeted LC-MS metabolomics performed by Metabolon. Values were batch-normalized by dividing each sample value by the batch-specific median for butyrate, and missing values were imputed using the minimum observed value across batches. The resulting values were log-transformed before analysis. Higher values indicate greater relative abundance of butyrate in stool. Because this measure reflects relative abundance rather than absolute concentration, there is no fixed theoretical range.
Outcome measures
| Measure |
Psyllium Fiber Supplement Treatment
n=30 Participants
All patients will receive psyllium fiber in the form of edible bars, 7g, twice a day to total 14g per day.
Psyllium: Psyllium fiber powder baked into a bar is commonly used as a first line of treatment for patients with fecal incontinence.
|
|---|---|
|
Change in Stool Butyrate Abundance Measured by Untargeted LC-MS Metabolomics
|
0.629 log(ratio)
Interval 0.248 to 1.506
|
SECONDARY outcome
Timeframe: Change from baseline to final visit. Through study completion, up to 6 weeks.Population: 1 Participant did not complete the study due to side effects from fiber bar consumption.
Questionnaire about the severity of symptoms in those with fecal incontinence. Consists of 4 questions, each rated on a scale of 1 to 6. Lower scores indicate higher severity of symptoms. (Min, 4, max 24)
Outcome measures
| Measure |
Psyllium Fiber Supplement Treatment
n=30 Participants
All patients will receive psyllium fiber in the form of edible bars, 7g, twice a day to total 14g per day.
Psyllium: Psyllium fiber powder baked into a bar is commonly used as a first line of treatment for patients with fecal incontinence.
|
|---|---|
|
Change in Fecal Incontinence Severity Assessed by Fecal Incontinence Severity Index (FISI)
|
-5 Score on a Scale
Interval -8.224 to -1.776
|
SECONDARY outcome
Timeframe: Change from baseline to final visit. Through study completion, up to 6 weeks.Population: 1 Participant did not complete the study due to side effects from fiber bar consumption.
Questionnaire about the quality of life of those with fecal incontinence. Questions are rated from 1 to 4 in each of 4 sections. Lower rating represent worse quality of life and higher scores represent higher quality of life. (Min 4, max, 16)
Outcome measures
| Measure |
Psyllium Fiber Supplement Treatment
n=30 Participants
All patients will receive psyllium fiber in the form of edible bars, 7g, twice a day to total 14g per day.
Psyllium: Psyllium fiber powder baked into a bar is commonly used as a first line of treatment for patients with fecal incontinence.
|
|---|---|
|
Change in Fecal Incontinence Quality of Life Assessed by Fecal Incontinence Quality of Life (FIQL)
|
1.761 Score on Scale
Interval 0.88 to 2.641
|
SECONDARY outcome
Timeframe: Change from baseline to final visit. Through study completion, up to 6 weeks.Population: 1 participant did not complete the study due to side effects from fiber bar consumption.
Squeeze pressure assessed using a pressure sensory for Anorectal manometry (ARM) procedure performed to measure anal and rectal muscle function and sensation.
Outcome measures
| Measure |
Psyllium Fiber Supplement Treatment
n=30 Participants
All patients will receive psyllium fiber in the form of edible bars, 7g, twice a day to total 14g per day.
Psyllium: Psyllium fiber powder baked into a bar is commonly used as a first line of treatment for patients with fecal incontinence.
|
|---|---|
|
Change in Anal Squeeze Pressure Assessed by Anorectal Manometry
|
-6.872 mmHg
Interval -32.95 to 19.206
|
SECONDARY outcome
Timeframe: Change from baseline to final visit. Through study completion, up to 6 weeks.Population: 1 Participant did not complete the study due to side effects from fiber bar consumption.
Translumbosacral anorectal magnetic stimulation (TAMS) performed during the ARM procedure to measure the change in the nerve conduction between the spinal cord and rectum.
Outcome measures
| Measure |
Psyllium Fiber Supplement Treatment
n=30 Participants
All patients will receive psyllium fiber in the form of edible bars, 7g, twice a day to total 14g per day.
Psyllium: Psyllium fiber powder baked into a bar is commonly used as a first line of treatment for patients with fecal incontinence.
|
|---|---|
|
Change in Lumbo and Sacral Nerve Latency Assessed by Translumbosacral Anorectal Magnetic Stimulation
|
-0.266 Milliseconds
Interval -0.794 to 0.262
|
SECONDARY outcome
Timeframe: Change from baseline to final visit. Through study completion, up to 6 weeks.Population: 1 Participant did not complete the study due to side effects from fiber bar consumption.
A 7-point scale indicating overall fecal incontinence symptom relief where 1 represents completely relieved and 7 represents completely worse.
Outcome measures
| Measure |
Psyllium Fiber Supplement Treatment
n=30 Participants
All patients will receive psyllium fiber in the form of edible bars, 7g, twice a day to total 14g per day.
Psyllium: Psyllium fiber powder baked into a bar is commonly used as a first line of treatment for patients with fecal incontinence.
|
|---|---|
|
Change in Relief Assessed by the Global Assessment of Relief
|
-1.885 Score on scale
Interval -2.27 to -1.499
|
SECONDARY outcome
Timeframe: Change from baseline to final visit. Through study completion, up to 6 weeks.Population: 1 Participant did not complete the study due to side effects from fiber bar consumption.
A 10-point scale indicating bloating severity where 0 represents the least severity and 10 represents the most severity.
Outcome measures
| Measure |
Psyllium Fiber Supplement Treatment
n=30 Participants
All patients will receive psyllium fiber in the form of edible bars, 7g, twice a day to total 14g per day.
Psyllium: Psyllium fiber powder baked into a bar is commonly used as a first line of treatment for patients with fecal incontinence.
|
|---|---|
|
Change in Bloating Scale Assessed by a Bloating Scale
|
0.885 Score on Scale
Interval -0.244 to 2.014
|
SECONDARY outcome
Timeframe: Change from baseline to final visit. Through study completion, up to 6 weeks.Population: 1 Participant did not complete the study due to side effects from fiber bar consumption.
A 10-point scale indicating urgency severity where 0 represents the least severity and 10 represents the most severity
Outcome measures
| Measure |
Psyllium Fiber Supplement Treatment
n=30 Participants
All patients will receive psyllium fiber in the form of edible bars, 7g, twice a day to total 14g per day.
Psyllium: Psyllium fiber powder baked into a bar is commonly used as a first line of treatment for patients with fecal incontinence.
|
|---|---|
|
Change in Urgency Assessed by an Urgency Scale
|
-2.538 Score on a Scale
Interval -3.681 to -1.395
|
SECONDARY outcome
Timeframe: Change from baseline to final visit. Through study completion, up to 6 weeks.Population: 1 Participant did not complete the study due to side effects from fiber bar consumption.
A 10-point scale indicating flatus severity where 0 represents the least severity and 10 represents the most severity
Outcome measures
| Measure |
Psyllium Fiber Supplement Treatment
n=30 Participants
All patients will receive psyllium fiber in the form of edible bars, 7g, twice a day to total 14g per day.
Psyllium: Psyllium fiber powder baked into a bar is commonly used as a first line of treatment for patients with fecal incontinence.
|
|---|---|
|
Change in Flatus Assessed by a Flatus Scale
|
-1.154 Score on a Scale
Interval -2.446 to 0.138
|
SECONDARY outcome
Timeframe: Change from baseline to final visit. Through study completion, up to 6 weeks.Population: 1 Participant did not complete the study due to side effects from fiber bar consumption.
A measure of the subject's waist circumference in the area where the most bloating is experienced
Outcome measures
| Measure |
Psyllium Fiber Supplement Treatment
n=30 Participants
All patients will receive psyllium fiber in the form of edible bars, 7g, twice a day to total 14g per day.
Psyllium: Psyllium fiber powder baked into a bar is commonly used as a first line of treatment for patients with fecal incontinence.
|
|---|---|
|
Change in Waist Circumference Measurement
|
-0.248 Centimeters (cm)
Interval -1.866 to 1.37
|
Adverse Events
Psyllium Fiber Supplement Treatment
Serious adverse events
| Measure |
Psyllium Fiber Supplement Treatment
n=31 participants at risk
All patients will receive psyllium fiber in the form of edible bars, 7g, twice a day to total 14g per day.
Psyllium: Psyllium fiber powder baked into a bar is commonly used as a first line of treatment for patients with fecal incontinence.
|
|---|---|
|
Nervous system disorders
Hospital Admission
|
3.2%
1/31 • Number of events 1 • 3 years
|
Other adverse events
| Measure |
Psyllium Fiber Supplement Treatment
n=31 participants at risk
All patients will receive psyllium fiber in the form of edible bars, 7g, twice a day to total 14g per day.
Psyllium: Psyllium fiber powder baked into a bar is commonly used as a first line of treatment for patients with fecal incontinence.
|
|---|---|
|
Gastrointestinal disorders
Abdominal Cramping, Increased Bowel Movements, Anal Pain
|
3.2%
1/31 • Number of events 2 • 3 years
|
|
Gastrointestinal disorders
Constipation, Bloating
|
3.2%
1/31 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Constipation, Bloating, Distention, Increased Gas
|
3.2%
1/31 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Increased Reflux, Bloating
|
3.2%
1/31 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Bloating, Gas, Change in stool consistency
|
3.2%
1/31 • Number of events 1 • 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place