A Study of Eluxadoline in Participants with Irritable Bowel Syndrome with Diarrhea (IBS-D) Who Have Evidence of Bile Acid Malabsorption (BAM)

Overview

About this study

This study is being done to evaluate the safety and effects of Food and Drug Administration (FDA) approved medication, Eluxadoline, on bowel function in study participants with IBS-D who do or do not have bile acid malabsorption (BAM). Eluxadoline has been approved by the FDA for people with IBS-D but it is not known whether it will work the same way in people with IBS-D who also have BAM.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Please contact the study team to discuss whether or not you are eligible to participate in a study.

Inclusion Criteria:

  • Adult men or women aged 18 to 75 years inclusive with a diagnosis of IBS-D per Rome IV criteria.
  • Participants with evidence of BAM must have at least one of the following at screening or within 1 calendar year prior to screening:
    • Fasting serum 7a-hydroxy-4-cholesten-3-at least one (7αC4) level ≥ 52.5 ng/mL;
    • Total fecal bile acid (BA) > 2337 micromoles/48 hours;
    • Primary bile acids (fecal CA and CDCA) > 10% in a 48-hour fecal collection;
    • Primary bile acids (fecal CA and CDCA)  ≥ 4% with total fecal bile acid  ≥ 1,000 micromoles/48 hours.
  • Participants without BAM must have at least one of the following at screening or within 1 calendar year prior to screening:
    • Fasting serum 7a-hydroxy-4-cholesten-3-one (7αC4) level ≤ 47.1;
    • Fasting serum 7a-hydroxy-4-cholesten-3-one (7αC4) level  ≥ 47.1 but ≤ 52.5 ng/mL with fecal bile acids that are negative for bile acid malabsorption (i.e., do not meet criteria 2.03 based on fecal bile acids level);
    • Total fecal bile acids (BA) ≤  2337 micromoles/48 hours;
    • Primary bile acids (fecal CA and CDCA) < 10% in a 48-hour fecal collection;
    • Primary bile acids (fecal CA and CDCA) < 4% with total fecal bile acid < 1,000 micromoles/48 hours.
  • An average daily Bristol Stool Form Scale (BSFS) score ≥ 5.0 or ≥ 25% of diary entry days with a BSFS score of 6 or 7 during the 14 days prior to Day 1.
  • Women of childbearing potential must use hormonal or double barrier contraception or maintain a monogamous relationship with a vasectomized male partner from the date of informed consent until 24 hours after final dose of study drug.
  • Completed the electronic diary (eDiary) on ≥ 10 of the 14 days prior to Day 1.
  • Has not used loperamide rescue medication on > 3 of the 14 days prior to Day 1.

Key Exclusion Criteria:

  • A diagnosis of IBS with a subtype of irritable bowel syndrome with constipation (IBS-C), mixed IBS, or unsubtyped IBS per Rome IV criteria.
  • Does not have a gallbladder.
  • Known or suspected biliary duct obstruction, or sphincter of Oddi disease or dysfunction. (Participants with a history of gallstones may be enrolled).
  • History of alcoholism, alcohol abuse or alcohol addiction, or drinks more than 3 alcoholic beverages per day.
  • History of pancreatitis; structural diseases of the pancreas, including known or suspected pancreatic duct obstruction.
  • History of mild, moderate, or severe hepatic impairment according to Child-Pugh classification. History or current diagnosis of inflammatory or immune-mediated gastrointestinal (GI) disorders.
  • Celiac disease or a positive serological test for celiac disease.
  • Known lactose or fructose intolerance associated with diarrhea, abdominal pain or discomfort, that could confound assessments in the study.
  • Women who are currently pregnant or nursing, or plan to become pregnant or nurse during the study.
  • Known allergies or hypersensitivity to opioids.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Michael Camilleri, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20403058

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