Investigation of Eluxadoline for Diabetic Diarrhea
Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
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.