Fat-reduced diet vs a bile acid binder as a treatment for bile acid malabsorption in patients previously treated for cancer in the pelvic region.

Phase 1

• Conditions: Bile acid malabsorption as a late side effect to cancer treatment in the pelvic region.; MedDRA version: 20.1Level: LLTClassification code 10080051Term: Bile acid diarrhoeaSystem Organ Class: 100000004856; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2019-004600-35-DK
• Lead Sponsor: Department of Hepatology and Gastroenterology, Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-04
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Patients previously treated for cancer in the pelvic region with a se-hcat scanned verified bile acid malabsorption, chronic diarrhoea, and a high fat-intake.
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 88
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

If less than 4 bowel movements per day.

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 effect of a bile acid binder to a low fat diet as a treatment for bile acid malabsorption as a consequence of previously cancer treatment in the pelvic region.<br><br>Treatment is successful if there is an at least 50% reduction in the number of daily loose bowel movements or in the daily number of bowel movements with urgency.;Secondary Objective: To see if the combination of a bile acid binder and the low fat diet is more effective than the treatment with either one.;Primary end point(s): Treatment is successful if there is an at least 50% reduction in the number of daily loose bowel movements or in the daily number of bowel movements with urgency.;Timepoint(s) of evaluation of this end point: After 6 weeks of treatment in either group.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Evaluation of the consistency of the stool, weekly fecal incontinence, the Gastrointestinal Symptom Rating Scale, EQ-5D, and weight at week 0, 42, and 70.;Timepoint(s) of evaluation of this end point: After 6 weeks of treatment