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The purpose of this study is to evaluate and compare treatment with fiber and loperamide for fecal incontinence.
Fecal incontinence (FI) affects 4-24% adults in the community and greatly impacts quality of life. Both fiber and loperamide are common, first-line treatments for diarrhea-associated FI in primary care. No known studies exist that compare fiber and loperamide for diarrhea-predominant FI. Further knowledge is needed to define which treatment is more effective and to compare drug tolerability (side effects) for FI. This study will also look at changes in quality of life with treatment and potential mechanisms of drug treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator | Fiber (psyllium) powder |
|
| Arm 2 | Active Comparator | Loperamide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psyllium powder | Drug | 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 7-day Bowel Diary, Number of Fecal Incontinence Episodes | 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. | 6 weeks and 12 weeks |
| Percentage of Bowel Movements With Incontinence | 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. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fecal Incontinence Severity Index Score, FISI | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alayne D Markland, DO MSc | VA Medical Center, Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Medical Center, Birmingham | Birmingham | Alabama | 35233 | United States |
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Outpatient medical clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | P1L2 (Psyllium First, Then Loperamide) | Fiber (psyllium) powder with loperamide placebo first Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 1 tablet daily with weekly dose adjustments for side-effects and/or efficacy |
| FG001 | L1P2 (Loperamide First, Then Pysllium) | Fiber (psyllium) powder placebo with loperamide 2mg Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (4-weeks) |
|
| |||||||||||||||||||||
| Wash-out (2-weeks) |
| ||||||||||||||||||||||
| Second Intervention (4-weeks) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | P1L2 (Psyllium First, Then Loperamide) | Fiber (psyllium) powder with loperamide placebo first Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 2 mg placebo daily with weekly dose adjustments for side-effects and/or efficacy |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 7-day Bowel Diary, Number of Fecal Incontinence Episodes | 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. | Posted | Mean | Standard Deviation | Fecal incontinence episodes | 6 weeks and 12 weeks |
|
We collected adverse event data during each 4-week intervention period.
Weekly phone calls were made to assess symptoms and adjust medication dosages.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | P1L2 (Psyllium First); 1st 4-weeks | Fiber (psyllium) powder with loperamide placebo first Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 1 tablet daily with weekly dose adjustments for side-effects and/or efficacy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| death | Gastrointestinal disorders | Non-systematic Assessment | sigmoid colon perforation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
Please note that the data on those lost to follow-up limits our ability to conclude differences between the two interventions.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alayne Markland, PI of this clinical trial | Birmingham VA Medical Center | 205-933-8101 | 6365 | alayne.markland@va.gov |
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| ID | Term |
|---|---|
| D005242 | Fecal Incontinence |
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D011620 | Psyllium |
| D008139 | Loperamide |
| ID | Term |
|---|---|
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Loperamide | Drug | 1 capsule daily for 28 days (weekly adjusted dose) |
|
| baseline, 4 week and 12 weeks |
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
| L1P2 (Loperamide First, Then Pysllium) |
Fiber (psyllium) powder placebo with loperamide 2mg pill Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| L1P2 (Loperamide First, Then Pysllium) |
Fiber (psyllium) powder placebo with loperamide 2mg Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy |
|
|
| Primary | Percentage of Bowel Movements With Incontinence | 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. | Posted | Mean | Standard Deviation | percentage of incontinent bowel movement | 4 weeks |
|
|
|
| Secondary | Fecal Incontinence Severity Index Score, FISI | 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. | Posted | Mean | Standard Deviation | units on a scale | baseline, 4 week and 12 weeks |
|
|
|
| 0 |
| 34 |
| 4 |
| 34 |
| EG001 | L1P2 (Loperamide First): 1st 4-weeks | Fiber (psyllium) powder placebo with loperamide 2mg Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy | 0 | 40 | 6 | 40 |
| EG002 | P1L2 (Loperamide Second); 2nd 4-weeks | Fiber (psyllium) powder placebo with loperamide 2mg Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy | 1 | 29 | 3 | 29 |
| EG003 | L1P2 (Psyllium Second); 2nd 4-weeks | Fiber (psyllium) powder with loperamide placebo first Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 1 tablet daily with weekly dose adjustments for side-effects and/or efficacy | 0 | 34 | 4 | 34 |
|
| constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| excessive flatus | Gastrointestinal disorders | Non-systematic Assessment |
|
| bloating | Gastrointestinal disorders | Non-systematic Assessment |
|
| heartburn | Gastrointestinal disorders | Non-systematic Assessment |
|
| headache | Nervous system disorders | Non-systematic Assessment |
|
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| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| End of Wash-out Period |
|
| End of Second Intervention |
|
| End of Second Intervention |
|