Contact information
Type
Scientific
Primary contact
Dr Mark Thompson-Fawcett
ORCID ID
Contact details
Department of Medical and Surgical Sciences
Dunedin School of Medicine
Universtiy of Otago
P.O. Box 913
Dunedin
9054
New Zealand
+64 (0)3 474 0999
mark.thompsonfawcett@otago.ac.nz
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
OEC 01/07/055
Study information
Scientific title
Acronym
Study hypothesis
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
Ethics approval received from Otago Ethics Committee on the 30th July 2001.
Study design
Double-blind randomised cross-over trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/12/2001
Overall trial end date
01/12/2004
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant 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
Recruitment start date
01/12/2001
Recruitment end date
01/12/2004
Locations
Countries of recruitment
New Zealand
Trial participating centre
Department of Medical and Surgical Sciences
Dunedin
9054
New Zealand
Sponsor information
Organisation
University of Otago (New Zealand)
Sponsor details
c/o Mark Thompson-Fawcett
Department of Medical and Surgical Science
Dunedin School of Medicine
P.O. Box 913
Dunedin
9054
New Zealand
+64 (0)3 474 0999
mark.thompsonfawcett@otago.ac.nz
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Otago (New Zealand) - Research Grant
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/pubmed/18190615
Publication citations
-
Results
Lauti M, Scott D, Thompson-Fawcett MW, Fibre supplementation in addition to loperamide for faecal incontinence in adults: a randomized trial., Colorectal Dis, 2008, 10, 6, 553-562, doi: 10.1111/j.1463-1318.2007.01439.x.