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

ISRCTN ISRCTN63627007
DOI https://doi.org/10.1186/ISRCTN63627007
Secondary identifying numbers OEC 01/07/055
Submission date
23/10/2007
Registration date
06/11/2007
Last edited
09/06/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Mark Thompson-Fawcett
Scientific

Department of Medical and Surgical Sciences
Dunedin School of Medicine
Universtiy of Otago
P.O. Box 913
Dunedin
9054
New Zealand

Phone +64 (0)3 474 0999
Email mark.thompsonfawcett@otago.ac.nz

Study information

Study designDouble-blind randomised cross-over trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesTo evaluate the efficacy of fibre supplementation and loperamide in comparison to a low-residue diet and lopermide in the conservative treatment of faecal incontinence.
Ethics approval(s)Ethics approval received from Otago Ethics Committee on the 30th July 2001.
Health condition(s) or problem(s) studiedFaecal incontinence
InterventionAll 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 patients were given both verbal instruction and an advice sheet about using loperamide which advised titrating the loperamide dose to firm stool but to avoid constipation. Glycerine suppositories were supplied for use in the event of troublesome constipation.

Patients were randomised to either combination treatment A or B for six weeks, crossed-over and re-evaluated after a further six weeks. It was assumed that it would take a week or two for the patients to adjust to the new treatment after cross over, and they were advised of this. They were asked to fill out the outcome questionnaires in relation to previous 4 weeks of the 6 weeks treatment period in each arm of the study. Both participants and clinicians/researchers were blinded.

Treatment A:
This consisted of:
1. An untitled dietary advice sheet for a balanced low residue diet
2. Placebo supplement (Karicare infant food thickener - light cream colored course powder containing pregelatinised maize starch, maltodextrin, locust bean gum) to be taken as one rounded teaspoon mixed in a glass of water at breakfast and dinner
3. Loperamide (taken as described above)

Treatment B:
This consisted of:
1. An untitled dietary advice sheet for a balanced diet consisting of both high and low residue items
2. Fibre supplement (psyllium hydrophilic mucilloid) to be taken as one rounded teaspoon with a glass of water at breakfast and dinner
3. Loperamide (taken as described above)

The dietary advice sheets were developed in consultation with the hospital Nutrition department. An important consideration in designing the dietary advice sheets was producing advice that would optimise compliance for a long term change, while encouraging healthy eating.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Loperamide, psyllium hydrophilic mucilloid
Primary outcome measureFaecal 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 outcome measures1. 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.
Overall study start date01/12/2001
Completion date01/12/2004

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants60
Key inclusion criteria1. 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
Key exclusion criteria1. Full thickness rectal prolapse
2. Inflammatory bowel disease
3. Other pathologies requiring surgery
4. Diabetes (chosen supplement contraindicated)
5. Previous treatment for faecal incontinence
Date of first enrolment01/12/2001
Date of final enrolment01/12/2004

Locations

Countries of recruitment

  • New Zealand

Study participating centre

Department of Medical and Surgical Sciences
Dunedin
9054
New Zealand

Sponsor information

University of Otago (New Zealand)
University/education

c/o Mark Thompson-Fawcett
Department of Medical and Surgical Science
Dunedin School of Medicine
P.O. Box 913
Dunedin
9054
New Zealand

Phone +64 (0)3 474 0999
Email mark.thompsonfawcett@otago.ac.nz
Website http://www.otago.ac.nz/
ROR logo "ROR" https://ror.org/01jmxt844

Funders

Funder type

University/education

University of Otago (New Zealand) - Research Grant

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 01/07/2008 Yes No