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

ISRCTN	ISRCTN63627007
DOI	https://doi.org/10.1186/ISRCTN63627007
Protocol serial number	OEC 01/07/055
Sponsor	University of Otago (New Zealand)
Funder	University of Otago (New Zealand) - Research Grant

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

Primary study design	Interventional
Study design	Double-blind randomised cross-over trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Loperamide, psyllium hydrophilic mucilloid
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	01/12/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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