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Investigating a Bile Acid Binder to Help Adults with Chronic Diarrhoea

Bile acid sequestrant tolerability and symptom change in adults with chronic diarrhoea

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000399493
Enrollment
100
Registered
2025-05-02
Start date
2025-06-01
Completion date
2026-12-01
Last updated
2025-09-08

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

Conditions

None listed

Brief summary

This study aims to evaluate the prevalence of people with bile acid malabsorption in a cohort of individuals with functional, chronic diarrhea in a health care setting. Each recruited participant will receive 14 days of cholestryramine. In addition, plasma samples will be collected to validate a novel plasma biomarker for specificity and sensitivity.

Interventions

Participants with functional chronic diarrhoea will receive 14 days of cholestyramine, a bile acid sequestrant in powder form, to drink dissolved in liquid according to manufacturer's guidelines: "QUESTRAN LITE should be taken mixed with water, juice or highly fluid foods. When mixing individual sachets for immediate use, place the contents of a 4g sachet of QUESTRAN LITE on the surface of 100-150mL water or fruit juice (200-300mL for an 8g sachet of QUESTRAN LITE). Mix immediately by stirring v

Participants with functional chronic diarrhoea will receive 14 days of cholestyramine, a bile acid sequestrant in powder form, to drink dissolved in liquid according to manufacturer's guidelines: "QUESTRAN LITE should be taken mixed with water, juice or highly fluid foods. When mixing individual sachets for immediate use, place the contents of a 4g sachet of QUESTRAN LITE on the surface of 100-150mL water or fruit juice (200-300mL for an 8g sachet of QUESTRAN LITE). Mix immediately by stirring vigorously or preferably by shaking in a Questran Lite shaker. Continue stirring or shaking until mixture is even. After dosing, rinse the container to ensure full dose. Alternatively, QUESTRAN LITE may be mixed with highly fluid soups, pulpy fruits with a high moisture content (e.g., apple puree or crushed pineapple), or if care is taken to avoid excessive foaming, a carbonated beverage.. Specifically, 4g of cholestyramine is equivalent to 4.7g Questran Lite (prescription brand name) per day in the evening or morning, increasing it to up to 12g cholestyramine /14.1g of Questran Lite over 14 days. Begin with 4g cholestyramine (4.7 QUESTRAN LITE) in the morning or evening, increasing to the required maintenance dose over 2 to 4 weeks." There is no strict protocol since the dose has to be adjusted individually, with input from the medical officer, depending on tolerability. Adherence is not monitored, as it is a prescription drug, and there are no lab tests available for monitoring.

Sponsors

University of Otago
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

BMI 17-37 Participants with a known diagnosis of IBS-D or Functional Diarrhoea (FD) Participants with a suspected diagnosis of IBS-D or FD, or chronic diarrhoea symptoms according to RomeIV criteria

Exclusion criteria

Current treatment with bile acid sequestrants Inability to give informed consent Known significant gastrointestinal disorder such as colorectal cancer, diverticulitis Coeliac disease Pregnancy Contraindications for bile-acid sequestrants Laxative use Those with symptoms atypical for functional gastrointestinal disease or where there is a high index of suspicion for other diagnoses (eg colorectal cancer, ischaemic colitis, infective colitis). Those with an acute health problem as determined through the biochemical blood panel

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026