Effects of Eluxadoline (Viberzi®) 100 mg Twice Daily on Diarrhea-Associated Fecal Incontinence
Effects of Eluxadoline (Viberzi®) 100 mg Twice Daily on Diarrhea-Associated Fecal Incontinence
Accidental bowel leakage (fecal incontinence) increases in people who have diarrhea and
 sensations of urgency to have a bowel movement. Drugs such as loperamide (Imodium) that
 reduce diarrhea improve accidental bowel leakage, but loperamide has disadvantages: it is
 difficult to find a dose that does not cause constipation, and it does not reduce urge
 sensations. Eluxadoline is a new drug that is effective for reducing diarrhea, abdominal
 pain, and urgency in patients with irritable bowel syndrome, and it may be less likely than
 loperamide to cause severe constipation. Therefore, eluxadoline may help patients manage
 accidental bowel leakage caused by diarrhea. The chemical name for Viberzi® is eluxadoline.

 The primary aims of this study are to find out if eluxadoline at a dose of 100 mg orally
 twice a day will reduce the average number of days the patient has accidental bowel leakage,
 and to see if the rate of accidental bowel leakage increases when the patient stops taking
 eluxadoline. Additional goals are to find out if eluxadoline decreases diarrhea and urge
 sensations.

 This is a small (pilot) study to show whether eluxadoline is an effective way of treating
 accidental bowel leakage. If the study shows this, a larger study will be needed. There are
 three phases to this 12-week study: (1) A two-week run-in period to see if the patient meets
 the inclusion criteria. (2) Two months for treatment including one month on eluxadoline and
 one on placebo (sugar pills) twice a day. (3) A two-week follow-up to see what happens when
 you stop taking eluxadoline.

 To participate in the study, patients should be aged 18 or older. Patients with inflammatory
 bowel disease, anal fissures, or congenital malformations will be excluded.

 The primary outcome is the average number of days per week with any solid or liquid bowel
 accidents. Additional information includes: (1) Number of days per week the patient takes
 loperamide, (2) days per week with loose or watery stools, (3) days per week with moderate to
 strong urge sensations, and (4) questionnaires to measure the severity of accidental bowel
 leakage, quality of life, anxiety, and depression. There will be up to 38 patients in the
 study.
Inclusion Criteria:

 1. At least 18 years of age.

 2. Any gender, race, or ethnicity.

 3. Must self-report an average of at least 2 episodes of solid or liquid FI per week for
 the previous month.

 4. Must self-report an average of at least 2 bowel movements (BMs) per week that are
 Bristol Types 6 or 7 (mushy or liquid stools).

 5. Subjects must have access to the internet at home and be willing to enter symptom data
 each night before sleeping.

 Exclusion Criteria:

 1. Patients with inflammatory bowel disease, anal fissure, or congenital malformations as
 a cause of FI will be excluded.

 2. Subjects who start the study and do not experience at least 4 episodes of solid or
 liquid FI and at least 4 BMs that are Bristol Stool types 6 or 7 during the first two
 weeks will be withdrawn from the study.

 3. Subjects who do not provide at least 4 days of valid stool diary data per week during
 the first two weeks will be withdrawn from the study.