Fibre supplementation in addition to loperamide for faecal incontinence in adults: a randomised trial
ISRCTN | ISRCTN63627007 |
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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
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 |
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mark.thompsonfawcett@otago.ac.nz |
Study information
Study design | Double-blind randomised cross-over trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study objectives | To 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) studied | Faecal incontinence |
Intervention | 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 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 type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Loperamide, psyllium hydrophilic mucilloid |
Primary outcome measure | 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 outcome measures | 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. |
Overall study start date | 01/12/2001 |
Completion date | 01/12/2004 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 60 |
Key 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 |
Key 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 |
Date of first enrolment | 01/12/2001 |
Date of final enrolment | 01/12/2004 |
Locations
Countries of recruitment
- New Zealand
Study participating centre
Department of Medical and Surgical Sciences
Dunedin
9054
New Zealand
9054
New Zealand
Sponsor information
University of Otago (New Zealand)
University/education
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 |
---|---|
mark.thompsonfawcett@otago.ac.nz | |
Website | http://www.otago.ac.nz/ |
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | Results | 01/07/2008 | Yes | No |