Condition category
Digestive System
Date applied
23/10/2007
Date assigned
06/11/2007
Last edited
09/06/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.otago.ac.nz/

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

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/18190615

Publication citations

  1. 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.

Additional files

Editorial Notes