ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 91 for:    Recruiting, Not yet recruiting, Available Studies | "Malabsorption Syndromes"
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03270085
Recruitment Status : Recruiting
First Posted : September 1, 2017
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
Michael Camilleri, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Chronic Diarrhea Irritable Bowel Syndrome With Diarrhea Bile Acid Malabsorption Drug: Colesevelam Other: Placebo Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
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.
Primary Purpose: Other
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 : November 20, 2018
Estimated Study Completion Date : November 20, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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.

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.

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.




Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Sara Linker Nord    507-266-1999    linkernord.sara@mayo.edu   
Contact: Kayla Arndt    507-538-6599    arndt.kayla@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Michael Camilleri Mayo Clinic

Responsible Party: Michael Camilleri, 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, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03270085     History of Changes
Other Study ID Numbers: 17-004639
First Posted: September 1, 2017    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Malabsorption Syndromes
Diarrhea
Irritable Bowel Syndrome
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases
Colesevelam Hydrochloride
Bile Acids and Salts
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Gastrointestinal Agents