A Study of the Efficacy, Safety and Tolerability of Enteric-Coated Cholestyramine Capsules for Adult Short Bowel Syndrome
Status:
Recruiting
Trial end date:
2021-11-01
Target enrollment:
Participant gender:
Summary
A new Enteric-Coated Cholestyramine (ECC) capsule has been developed to manage diarrhea
associated with Short Bowel Syndrome (SBS) in adults. The formulation is expected to release
cholestyramine in the remaining segment of the small intestine in SBS patients, thus binding
bile acids after fat digestion, but before induction of diarrhea in the colon. The
delayed-release profile is also expected to help reduce the potential for drug-drug
interactions occurring in the proximal small intestine. Two doses of ECC will be studied for
efficacy, safety and tolerability in this Phase IIa trial.