Ensayos clínicos

Inclusion criteria

• Prior diagnosis of bile acid diarrhea as documented by either.
  • total bile acid in 48 hour stool excretion of 2337 micromoles per 48 hours; or
  • greater than 1000 micromoles per 48 hours with greater than 4% primary bile acids in stool; or
  • greater than 10% primary bile acid (CA and CDCA) in stool 48 hour collection; or
  • serum 7 alpha C4 greater than 52 ng/mL.
• Age 18-70 years old.
• BMI <40 kg/m^2.
• Prior cholecystectomy, appendectomy, and tubal ligation or hysterectomy will all be permissible for participation in the study. 
• Participants receiving bile acid sequestrant will not be permitted to continue therapy and need to stop one week before baseline test.
• No use of oral antibiotics and NSAIDs for 2 weeks prior to study treatment.

Exclusion criteria

• Diabetes mellitus (type 1).
• Diabetes mellitus type 2 if taking metformin or GLP-1 agonist treatment (exenatide, liraglutide, semaglutide).
• Uncontrolled hypertension (with BP measured > 140/90mmHg in the CRTU).
• BMI ≥ 40 kg/m^2
• Chronic NSAID use (>1 day/week).
• Use of oral antibiotics and NSAIDs for 2 weeks prior to and during the entire 28 day study period.
• Diagnosis of gastrointestinal diseases that are associated with inflammation such as inflammatory bowel diseases and celiac disease or gastrointestinal infection in the prior 4 weeks.
• Prior intestinal or colonic resection; note prior cholecystectomy, appendectomy, and tubal ligation or hysterectomy will all be permissible for participation in the study.
• Participation in highly vigorous exercise such as running >5 miles per day in week prior to the permeability test.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 6/6/23. Questions regarding updates should be directed to the study team contact.