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

Irritable Bowel Syndrome With Diarrhea Clinical Trial

Official title:

Randomized, Double Blinded, Placebo Controlled Trial to Understand Efficacy of Colesevelam in Diarrhea Predominant IBS Patients With Bile Acid Malabsorption

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03270085
• Other study ID #: 17-004639
• Secondary ID: R01DK115950UL1TR
• Status: Completed
• Phase: Phase 2
• Start date: December 7, 2017
• Est. completion date: May 31, 2019

Study information

• Verified date: March 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Bile Acid Malabsorption
• Chronic Diarrhea
• Diarrhea
• Irritable Bowel Syndrome
• Irritable Bowel Syndrome With Diarrhea
• Malabsorption Syndromes

Intervention

Drug:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Vijayvargiya P, Camilleri M, Carlson P, Nair A, Linker Nord S, 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 Di — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Fecal Bile Acid (BA) Excretion	Total fecal BA excretion was measured using High Performance Liquid Chromatography (HPLC)/tandem mass spectrometry (MS) where single stool samples obtained at baseline and end of treatment were prepared by assay by HPLC/MS by methanol extraction and results are presented as micromoles per gram (µmoles/g) of stool.	Treatment day 28
Primary	Stool Consistency	Stool consistency as reported by the participant via daily bowel diaries. Stool consistency was based on Bristol Stool Form Scale (BSFS) where 1 - hard lumps, 2 - lumpy sausage, 3 - cracked sausage, 4 - smooth sausage, 5 - soft lumps, 6 - mushy, and 7 - watery. Stool consistency was averaged for the 28 day treatment period.	Treatment days 1 through 28
Secondary	Number of Stools Per Day	The total number of bowel movements as reported by the participant via daily bowel diaries. The number of bowel movements were averaged for the 28 day treatment period.	Treatment days 1 through 28

External Links

•   Mayo Clinic Clinical Trials