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Fibre supplementation in addition to loperamide for faecal incontinence in adults: a randomised trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN63627007
Enrollment
60
Registered
2007-11-06
Start date
2001-12-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Faecal incontinence Digestive System Faecal incontinence

Interventions

All patients received loperamide. Most patients were advised to start by taking one tablet (2 mg) twice a day. Patients with a tendency to constipation were advised to start on one tablet daily. All p

Sponsors

University of Otago (New Zealand)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Over eighteen years of age 2. Referred to an outpatient colorectal service with the primary presenting problem of chronic incontinence to mucus, liquid and/or solid stool 3. Living independently 4. Able to read and complete the study information and questionnaires

Exclusion criteria

Exclusion criteria: 1. Full thickness rectal prolapse 2. Inflammatory bowel disease 3. Other pathologies requiring surgery 4. Diabetes (chosen supplement contraindicated) 5. Previous treatment for faecal incontinence

Design outcomes

Primary

MeasureTime frame
Faecal Incontinence Severity Index (FISI) patient-weighted score, measured at baseline, 6 weeks at cross over and at 12 weeks at conclusion of the second treatment period.

Secondary

MeasureTime frame
1. 36-item Short Form health survey (SF-36) 2. Faecal Incontinence Quality of Life scale (FIQL) All questionnaires were performed at baseline, 6 weeks at cross over and at 12 weeks at conclusion of the second treatment period.

Countries

New Zealand

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026