Efficacy and Mechanisms of Pharmacologic Treatment of Fecal Incontinence

NCT00727649 | Completed Phase 2 Results

• 1 other identifier: B6126-W
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate and compare treatment with fiber and loperamide for fecal incontinence.

Conditions

Fecal Incontinence

Keywords

fecal incontinence; adults; diarrhea

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Fecal Incontinence Severity Index Score, FISI

  baseline, 4 week and 12 weeks

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Fiber (psyllium) powder

Drug: Psyllium powder

Arm 2

ACTIVE COMPARATOR

Loperamide

Drug: Loperamide

Interventions

Psyllium powder DRUG

2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose)

Also known as: Metamucil

Arm 1

Loperamide DRUG

1 capsule daily for 28 days (weekly adjusted dose)

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• weekly fecal incontinence

You may not qualify if:

• fecal impaction
• inability to complete a baseline 1-week bowel diary
• rectal prolapse
• any prior radiation to the pelvis
• colo-rectal cancer
• rectal fistula
• inflammatory bowel disease
• neurological diseases (spinal cord injury, multiple sclerosis, Parkinson's disease)
• constipation (\<2 bowel movements/week) or total colectomy

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA Medical Center, Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Fecal Incontinence; Diarrhea

Interventions

Psyllium; Loperamide

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Please note that the data on those lost to follow-up limits our ability to conclude differences between the two interventions.

Results Point of Contact

• Title: Dr. Alayne Markland, PI of this clinical trial
• Organization: Birmingham VA Medical Center

alayne.markland@va.gov

205-933-8101

Study Officials

• Alayne D Markland, DO MSc

  VA Medical Center, Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2008
• First Posted: August 4, 2008
• Study Start: July 1, 2008
• Primary Completion: October 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 1, 2015
• Results First Posted: April 1, 2015

Record last verified: 2015-03

Locations

US (1)