Clinical trial NCT03270085: Trial to Understand Efficacy of Colesevelam in Diarrhea Predominant IBS Patients With Bile Acid Malabsorption
Official title: Randomized, Double Blinded, Placebo Controlled Trial to Understand Efficacy of Colesevelam in Diarrhea Predominant IBS Patients With Bile Acid Malabsorption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Diarrhea
Irritable Bowel Syndrome With Diarrhea
Bile Acid Malabsorption
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2017-09-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is the third specific aim of a program on IBS-D with increased fecal bile acid excretion.
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Total Fecal Bile Acid (BA) Excretion
timeFrame: Treatment day 28
measure: Stool Consistency
timeFrame: Treatment days 1 through 28
Secondary outcomes:
measure: Number of Stools Per Day
timeFrame: Treatment days 1 through 28
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Michael Camilleri
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vijayvargiya P, Camilleri M, Carlson P, Nair A, Nord SL, Ryks M, Rhoten D, Burton D, Busciglio I, Lueke A, Harmsen WS, Donato LJ. Effects of Colesevelam on Bowel Symptoms, Biomarkers, and Colonic Mucosal Gene Expression in Patients With Bile Acid Diarrhea in a Randomized Trial. Clin Gastroenterol Hepatol. 2020 Dec;18(13):2962-2970.e6. doi: 10.1016/j.cgh.2020.02.027. Epub 2020 Feb 21.