Trial · NCT00727649
Efficacy and Mechanisms of Pharmacologic Treatment of Fecal Incontinence
NCT00727649, Phase 2, Phase 3, Completed, US Department of Veterans Affairs; results first posted 2015-04-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Mechanisms of Pharmacologic Treatment of Fecal Incontinence. Trials, record NCT00727649. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00727649
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Mechanisms of Pharmacologic Treatment of Fecal Incontinence
- NCT number
- NCT00727649
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 80 participants, actual
- Lead sponsor
- US Department of Veterans Affairs
- Conditions
- Fecal Incontinence
- Interventions
- Psyllium powder, Loperamide
- First posted
- 2008-08-04
- Last updated
- 2015-04-01
- Results first posted
- 2015-04-01
- Limitations and caveats
- Please note that the data on those lost to follow-up limits our ability to conclude differences between the two interventions.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 7-day Bowel Diary, Number of Fecal Incontinence Episodes | 6 weeks and 12 weeks | After consent, 7-day bowel diary was assessed at baseline (2-week visit), during the last week of the 4-week intervention (6-week visit), during the second week of the 2-week wash-out period at 8-weeks, and during the last week of the second 4-week intervention (12 weeks). The mean number of total fecal incontinence episodes from a 7-day bowel diary from each time point was compared between the groups. |
| Primary | Percentage of Bowel Movements With Incontinence | 4 weeks | After consent, 7-day bowel diary was assessed at baseline (2-week visit), during the last week of the 4-week intervention (6-week visit), during the second week of the 2-week wash-out period at 8-weeks, and during the last week of the second 4-week intervention (12 weeks). We compared the percentage of the total number of fecal incontinence episodes over the total number of bowel movements from a 7-day bowel diary from each time point between the groups. |
| Secondary | Fecal Incontinence Severity Index Score, FISI | baseline, 4 week and 12 weeks | The patient-reported symptoms severity score, the Fecal Incontinence Severity Index (FISI), has 4 questions about the frequency of gas, mucus, liquid stool, and solid stool incontinence. Responses are weighted based on the patient rating of severity and a total score is calculated (range 0-61) with higher scores indicating a greater severity of symptoms. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 7-day Bowel Diary, Number of Fecal Incontinence Episodes | 6 weeks and 12 weeks | Fecal incontinence episodes | MEAN | |
| PRIMARY | Percentage of Bowel Movements With Incontinence | 4 weeks | percentage of incontinent bowel movement | MEAN | |
| SECONDARY | Fecal Incontinence Severity Index Score, FISI | baseline, 4 week and 12 weeks | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 7-day Bowel Diary, Number of Fecal Incontinence Episodes | P1L2 (Psyllium First, Then Loperamide) | Baseline | 7.3 | Standard Deviation 6.2 | Fecal incontinence episodes |
| 7-day Bowel Diary, Number of Fecal Incontinence Episodes | L1P2 (Loperamide First, Then Pysllium) | Baseline | 7.9 | Standard Deviation 7.5 | Fecal incontinence episodes |
| 7-day Bowel Diary, Number of Fecal Incontinence Episodes | P1L2 (Psyllium First, Then Loperamide) | End of First Intervention | 4.8 | Standard Deviation 4.8 | Fecal incontinence episodes |
| 7-day Bowel Diary, Number of Fecal Incontinence Episodes | L1P2 (Loperamide First, Then Pysllium) | End of First Intervention | 4.1 | Standard Deviation 5.1 | Fecal incontinence episodes |
| 7-day Bowel Diary, Number of Fecal Incontinence Episodes | P1L2 (Psyllium First, Then Loperamide) | End of Wash-out Period | 4.3 | Standard Deviation 4.2 | Fecal incontinence episodes |
| 7-day Bowel Diary, Number of Fecal Incontinence Episodes | L1P2 (Loperamide First, Then Pysllium) | End of Wash-out Period | 5.0 | Standard Deviation 6.2 | Fecal incontinence episodes |
| 7-day Bowel Diary, Number of Fecal Incontinence Episodes | P1L2 (Psyllium First, Then Loperamide) | End of Second Intervention | 3.5 | Standard Deviation 6.6 | Fecal incontinence episodes |
| 7-day Bowel Diary, Number of Fecal Incontinence Episodes | L1P2 (Loperamide First, Then Pysllium) | End of Second Intervention | 4.7 | Standard Deviation 5.7 | Fecal incontinence episodes |
| Percentage of Bowel Movements With Incontinence | P1L2 (Psyllium First, Then Loperamide) | Baseline | 30.5 | Standard Deviation 18.0 | percentage of incontinent bowel movement |
| Percentage of Bowel Movements With Incontinence | L1P2 (Loperamide First, Then Pysllium) | Baseline | 32.3 | Standard Deviation 23.4 | percentage of incontinent bowel movement |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention (4-weeks) | STARTED | P1L2 (Psyllium First, Then Loperamide) | 37 | |
| First Intervention (4-weeks) | STARTED | L1P2 (Loperamide First, Then Pysllium) | 43 | |
| First Intervention (4-weeks) | COMPLETED | P1L2 (Psyllium First, Then Loperamide) | 34 | |
| First Intervention (4-weeks) | COMPLETED | L1P2 (Loperamide First, Then Pysllium) | 40 | |
| First Intervention (4-weeks) | NOT COMPLETED | P1L2 (Psyllium First, Then Loperamide) | 3 | |
| First Intervention (4-weeks) | NOT COMPLETED | L1P2 (Loperamide First, Then Pysllium) | 3 | |
| Wash-out (2-weeks) | STARTED | P1L2 (Psyllium First, Then Loperamide) | 34 | |
| Wash-out (2-weeks) | STARTED | L1P2 (Loperamide First, Then Pysllium) | 40 | |
| Wash-out (2-weeks) | COMPLETED | P1L2 (Psyllium First, Then Loperamide) | 30 | |
| Wash-out (2-weeks) | COMPLETED | L1P2 (Loperamide First, Then Pysllium) | 37 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events32
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | abdominal pain | Gastrointestinal disorders | P1L2 (Psyllium First); 1st 4-weeks | 3 | 34 | 3 |
| other | abdominal pain | Gastrointestinal disorders | L1P2 (Loperamide First): 1st 4-weeks | 6 | 40 | 6 |
| other | abdominal pain | Gastrointestinal disorders | P1L2 (Loperamide Second); 2nd 4-weeks | 3 | 29 | 3 |
| other | abdominal pain | Gastrointestinal disorders | L1P2 (Psyllium Second); 2nd 4-weeks | 2 | 34 | 2 |
| other | constipation | Gastrointestinal disorders | P1L2 (Psyllium First); 1st 4-weeks | 3 | 34 | 3 |
| other | constipation | Gastrointestinal disorders | L1P2 (Loperamide First): 1st 4-weeks | 4 | 40 | 4 |
| other | constipation | Gastrointestinal disorders | P1L2 (Loperamide Second); 2nd 4-weeks | 3 | 29 | 3 |
| other | constipation | Gastrointestinal disorders | L1P2 (Psyllium Second); 2nd 4-weeks | 3 | 34 | 3 |
| other | diarrhea | Gastrointestinal disorders | P1L2 (Psyllium First); 1st 4-weeks | 2 | 34 | 2 |
| other | diarrhea | Gastrointestinal disorders | L1P2 (Loperamide First): 1st 4-weeks | 6 | 40 | 6 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | P1L2 (Psyllium First); 1st 4-weeks | ||
| Total, all-cause mortality | L1P2 (Loperamide First): 1st 4-weeks | ||
| Total, all-cause mortality | P1L2 (Loperamide Second); 2nd 4-weeks | ||
| Total, all-cause mortality | L1P2 (Psyllium Second); 2nd 4-weeks | ||
| Total, other adverse events | P1L2 (Psyllium First); 1st 4-weeks | 4 | 34 |
| Total, other adverse events | L1P2 (Loperamide First): 1st 4-weeks | 6 | 40 |
| Total, other adverse events | P1L2 (Loperamide Second); 2nd 4-weeks | 3 | 29 |
| Total, other adverse events | L1P2 (Psyllium Second); 2nd 4-weeks | 4 | 34 |
| Total, serious adverse events | P1L2 (Psyllium First); 1st 4-weeks | 0 | 34 |
| Total, serious adverse events | L1P2 (Loperamide First): 1st 4-weeks | 0 | 40 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00727649
GET https://conductscience.org/api/trials/v1/NCT00727649/results?page=2