Trial to Understand Efficacy of Colesevelam in Diarrhea Predominant IBS Patients With Bile Acid Malabsorption
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|ClinicalTrials.gov Identifier: NCT03270085|
Recruitment Status : Recruiting
First Posted : September 1, 2017
Last Update Posted : December 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Diarrhea Irritable Bowel Syndrome With Diarrhea Bile Acid Malabsorption||Drug: Colesevelam Other: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||This is the third specific aim of a program on IBS-D with increased fecal bile acid excretion.|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||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.|
|Official Title:||Randomized, Double Blinded, Placebo Controlled Trial to Understand Efficacy of Colesevelam in Diarrhea Predominant IBS Patients With Bile Acid Malabsorption|
|Actual Study Start Date :||December 7, 2017|
|Estimated Primary Completion Date :||July 20, 2018|
|Estimated Study Completion Date :||July 20, 2018|
Active Comparator: 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.
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 Comparator: 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.
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.
- Patients with IBS-D with increased bowel bile acid will be treated with colesevelam to determine if stool frequency and consistency improves via daily bowel diaries. [ Time Frame: Five to Nine Weeks ]This study will evaluate baseline and post treatment (colesevelam) stool consistency and frequency via daily bowel diaries.
- Patients with IBS-D with increased bowel bile acid will be treated with colesevelam to determine if stool frequency and consistency improves via fecal bile acids. [ Time Frame: Five to Nine Weeks ]This study will evaluate baseline and post treatment (colesevelam) fecal bile acids.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03270085
|United States, Minnesota|
|Mayo Clinic in Rochester||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Contact: Sara Linker Nord 507-266-1999 firstname.lastname@example.org|
|Contact: Kayla Arndt 507-538-6599 email@example.com|
|Principal Investigator:||Michael Camilleri||Mayo Clinic|