Trial to Understand Efficacy of Colesevelam in Diarrhea Predominant IBS Patients With Bile Acid Malabsorption

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-07

Study Completion Date

2019-05-31

Brief Summary

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To compare with a randomized trial (n=15 per treatment group), effects of colesevelam and placebo treatment, on colonic transit, bowel functions, permeability and tight junction expression in rectosigmoid mucosa of IBS-D with Bile Acid Malabsorption.

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Detailed Description

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Compare the effects of Colesevelam versus the placebo on diabetic subjects with chronic diarrhea. In this study, diabetic subjects will get either the Colesevelam or the placebo, not both.

The plan is to have about 30 subjects complete this study at Mayo Clinic.

Conditions

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Chronic Diarrhea Irritable Bowel Syndrome With Diarrhea Bile Acid Malabsorption

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is the third specific aim of a program on IBS-D with increased fecal bile acid excretion.

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

30 subjects with irritable bowel syndrome and diarrhea and bile acid malabsorption will be randomized into 15 people per group in 4-week double-blind, parallel-group trial to Colesevelam or placebo.

Study Groups

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Colesevelam

Once randomized, subjects will have baseline testing period, treatment period, and treatment testing period the study drug. This consists of nine visits and will be over a period of five to nine weeks.

Baseline testing period consists of: transit test, 4 day high fat diet with 48 hour stool collection, blood samples, rectosigmoid biopsies, one week stool diary, and medication pick up.

Treatment period will have subject take the study drug 1875 mg of medication orally twice daily with lunch and supper for 4-5 weeks.

The last period, is the treatment testing period. This consists of a full transit \& urine permeability test, 4 day high fat diet with 48 hour stool collection, blood samples, one week stool diary collection, and the return of the unused medication.

Group Type ACTIVE_COMPARATOR

Colesevelam

Intervention Type DRUG

Colesevelam (Welchol) is approved by the Food and Drug Administration (FDA) for the treatment of high blood cholesterol levels and to treat type 2 diabetes however, Colesevelam is not approved for the use proposed in this study and is considered investigational.

Placebo

Once randomized, subjects will have a baseline testing period, treatment period and treatment testing period with the placebo. This consists of nine visits and will be over a period of five to nine weeks.

The last period, is the treatment testing period. This consists of a full transit \& urine permeability test, 4 day high fat diet with 48 hour stool collection, blood samples, one week stool diary collection, and the return of the unused placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

A placebo looks exactly like the study drug, but it contains no active ingredient. This is used to learn if the effects seen in research participants are truly from the study drug.

Interventions

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Colesevelam

Colesevelam (Welchol) is approved by the Food and Drug Administration (FDA) for the treatment of high blood cholesterol levels and to treat type 2 diabetes however, Colesevelam is not approved for the use proposed in this study and is considered investigational.

Intervention Type DRUG

Placebo

A placebo looks exactly like the study drug, but it contains no active ingredient. This is used to learn if the effects seen in research participants are truly from the study drug.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Females and males age 18 -75.
* An IBS diagnosis based on the Rome III criteria for at least 3 months, with onset at least 6 months previously, of recurrent abdominal pain or discomfort.
* Biomarkers serum alpha C4 ≥ 40 ng/mL or FGF19 ≤ 80 pg/mL or fecal bile acid \>2000 micromoles/48h

Exclusion Criteria

* IBS patients with known clinically-relevant inflammation.
* IBS patient with known bleeding diathesis
* History of abdominal surgery

Patients participating will not take any of the following disallowed medications for at least 7 days prior to and during the remainder of the study:

* Any treatment specifically taken for IBS-D, including loperamide, cholestyramine, alosetron
* Drugs with a known pharmacological activity at 5-HT4, 5-HT2b or 5-HT3 receptors
* All narcotics
* Anti-cholinergic agents
* Tramadol
* Oral anticoagulants
* Antimuscarinics
* Peppermint oil
* Systemic antibiotics, as well as antibiotics directed at colonic flora such as rifaximin and metronidazole

Gastrointestinal preparations:

* Anti-nausea agents
* Osmotic laxative agents
* Prokinetic agents
* 5-HT3 antagonists

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Michael Camilleri, MD

Michael Camilleri, M.D. Professor of Medicine, Pharmacology and Physiology, Atherton and Winifred W. Bean Professor, College of Medicine Consultant, Division of Gastroenterology and Hepatology

Responsibility Role PRINCIPAL_INVESTIGATOR