A comparison of the efficacy of dietary hydroxypropylcellulose and questran as therapeutic agents in bile acid induced diarrhoea - Hydroxypropylcellulose and questran compared

Status

Active, not recruiting

Phases

Phase 2Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-001054-84-GB

Enrollment

Registered

2005-03-16

Start date

2005-02-16

Completion date

Unknown

Last updated

2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Product Name: KLUCEL - PHARM Type HF Pharmaceutical Form: Oral solution CAS Number: 9004-64-2 Other descriptive name: hydroxypropylcellulose Concentration unit: g gram(s) Concentration type: equal Con

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the effectiveness of hydroxypropylcellulose and questran in reducing diarrhoea in different groups of patients with bile acid malabsorption. 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 Reduction in defaecation urgency reduction in stool frequency improved quality of life	—

Measure

Time frame

Main Objective: To compare the effectiveness of hydroxypropylcellulose and questran in reducing diarrhoea in different groups of patients with bile acid malabsorption. 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 Reduction in defaecation urgency reduction in stool frequency improved quality of life

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026