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.

Fat-reduced diet vs. bile acid binder as a treatment for bile acid malabsorption in patients with chronic diarrhoea as a late side effect after cancer treatment in the pelvic region - a randomised, controlled trial.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004600-35-DK

Enrollment

Registered

2019-12-04

Start date

2020-02-25

Completion date

Unknown

Last updated

2024-01-08

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

Conditions

Bile acid malabsorption as a late side effect to cancer treatment in the pelvic region. MedDRA version: 20.1 Level: LLT Classification code 10080051 Term: Bile acid diarrhoea System Organ Class: 100000004856

Interventions

Trade Name: Colestyramin Product Name: Colestyramin Product Code: 2922 Pharmaceutical Form: Powder and solvent for oral solution INN or Proposed INN: COLESTYRAMINE Other descriptive name: bile acid bi

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: If less than 4 bowel movements per day.

Design outcomes

Primary

Measure	Time frame
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. 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.	—

Measure

Time frame

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. 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.

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Secondary

Measure	Time frame
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	—

Countries

Denmark

Contacts

Public ContactJanne Fassov

Department of Hepatology and Gastroenterology, Aarhus University Hospital

janfas@rm.dk

Outcome results

None listed

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