Investigation of Eluxadoline for Diabetic Diarrhea

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Diabetes is a chronic disease that affects a large part of the United States population. The majority of patients with diabetes will experience gastrointestinal symptoms. One of the most troublesome gastrointestinal symptoms that diabetes can cause is diarrhea, otherwise known as "Diabetic Diarrhea." This occurs because diabetes does damage to nerves that control the gut and prevent it from functioning normally. Currently, there are only several medications used to treat the symptoms of Diabetic Diarrhea, but many of these medications have serious side effects or do not work well.

We are investigating the drug eluxadoline for the treatment of Diabetic Diarrhea. Eluxadoline is a gut-specific medication that is FDA approved to treat diarrhea related to irritable bowel syndrome (IBS-D). Our hypothesis is eluxadoline will safely and successfully reduce diarrhea symptoms (number of stools and less liquid stools) and improve the quality of life in patients with Diabetic Diarrhea when compared with placebo. Each patient with Diabetic Diarrhea who participates will take both eluxadoline and a placebo drug at separate times over a period of several months as part of a crossover study design. While on each medication, eluxadoline or placebo, the participants will keep a diary of symptoms and will be followed by the medical team through a combination of office visits and questionnaires. There will be five planned office visits and intermittent phone calls (questionnaires, surveys) over the 140-day study period. Participants will not be permitted to use any other anti-diarrhea medication during the study period and will continue on medication for management of their diabetes.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Temple University
• Treatments: Eluxadoline

Criteria

Inclusion Criteria:

• Age ≥ 18 years

• Documented diabetes mellitus (DM) Type I or DM Type II - must be on medical therapy

• ≥ 3 bowel movements per day with Bristol type 6 or 7 stools at least 4 days per week for > 6 months. They must continue to meet these criteria during the 4 week pre-randomization phase.

• Normal sigmoidoscopy or colonoscopy with biopsies negative for microscopic colitis

• Negative work up for Clostridium difficile

• Negative work up for Celiac Disease either by assessment of serum tissue transglutaminase Immunoglobulin A (IgA) or by small bowel biopsy

• Normal fecal elastase and fecal calprotectin levels

• Normal thryoid stimulating hormone (TSH) level

Exclusion Criteria:

• Subjects who, in the estimation of the investigator, have drug-induced diarrhea

• Subjects unwilling to stop anti-diarrheal medications during the study

• Pregnancy or nursing mothers

• History of Cholecystectomy or Sphincter of Oddi Dysfunction

• Patients unable to undergo sigmoidoscopy or colonoscopy

• Patients with a history of inflammatory bowel disease (IBD)

• Prior history of pancreatitis

• Patients with hepatic impairment

• Patients who consume ≥ 3 alcoholic beverages per day

• Patients on oral opioids, who abuse illicit opioids, or have had a history of opioid abuse

• Patients on OATP1B1 Inhibitors (Rifampicin, Clarithromycin, Erythromycin, Cyclosporine, Gemfibrozil)

• Patients for whom inclusion in the study would be dangerous

• Subjects unable to consent