A comparison of the efficacy of dietary hydroxypropylcellulose and questran as therapeutic agents in bile acid induced diarrhoea - Hydroxypropylcellulose and questran compared
Phase 1
- Conditions
- these patients will have bile acid induced diarrhoea identified by an increased serum 7a-OH-cholestenone.and will have a history of one of 1. ileal resection 2. idiopathic bile acid diarrhoea.3. post cholecystectomy diarrhoea
- Registration Number
- EUCTR2004-001054-84-GB
- Lead Sponsor
- HS Lothian- University Hospitals Division
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Patients will have bile acid induced diarrhoea - frequently passing 5-7 watery stools per day
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
less than 16 years in age
currently taking other anti diarrhoeals eg loperamide
presence of active inflammation
currently using anti inflammatory agents such as prednisolone.
5-ASA or azothioprine will be allowed if patient is in remission
Patients unable to give informed consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the effectiveness of hydroxypropylcellulose and questran in reducing diarrhoea in different groups of patients with bile acid malabsorption.<br><br>is HPC asuitable alternative to questran in these clinical circumstances?;Secondary Objective: Is the action of hydroxypropyl cellulose different from questran? - measurement of serum 7a-OH-cholestenone a marker of bile acid turnover, should help answer this question;Primary end point(s): reduction in diarrheoa<br>Reduction in defaecation urgency<br>reduction in stool frequency<br>improved quality of life
- Secondary Outcome Measures
Name Time Method