Phase 2 Randomized Study of Oral Crofelemer for Adults with Short Bowel Syndrome and Intestinal Failure Without Colon-in-Continuity

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effectiveness of crofelemer in adults with Short Bowel Syndrome and Intestinal Failure SBS-IF who do not have colon-in-continuity and require parenteral support. This randomized, placebo-controlled, double-blind Phase 2 study aims to compare two doses of crofelemer with a placebo over a 24-week period. The study includes patients who are dependent on parenteral support and have chronic non-infectious diarrhea. Participants will be randomized to receive either crofelemer 3 mgkgdose, crofelemer 10 mgkgdose, or a matching placebo. The study drug is given orally or enterally three times daily morning, midday, and evening for 24 weeks. Before starting treatment, patients undergo up to a 4-week screening period followed by a parenteral support stabilization period lasting 2 to 12 weeks. After the 24-week treatment period, there will be a 4-week safety follow-up. During the study, participants will have visits at baseline and at weeks 1, 2, 4, 8, 12, 16, 20, and 24. Researchers will monitor safety, tolerability, and preliminary efficacy by assessing changes in parenteral support volume, stool characteristics, laboratory values, and physical exams. The study will measure outcomes related to parenteral support needs and stool consistency. After treatment, participants are followed for safety for 4 weeks. Total participation includes screening, stabilization, treatment, and follow-up periods.

Safety and Efficacy of Crofelemer in Adult Patients With Short Bowel Syndrome and Intestinal Failure (SBS-IF) Without Colon-in-continuity (CIC)