Pilot Study of Crofelemer Treatment in Adults With Short Bowel Syndrome on Parenteral Support

What this Trial Is About

This research aims to evaluate the effectiveness and safety of crofelemer treatment in adults with Short Bowel Syndrome SBS who have an ileostomy and rely on parenteral support PS. SBS occurs when less than 200 cm of small bowel remains, leading to poor absorption of nutrients and fluids and causing severe diarrhea that impacts health and quality of life. Current diarrhea management in SBS is challenging and involves multiple medications, but better treatments are needed. Crofelemer, an FDA-approved drug for HIV-associated diarrhea, is being studied for its potential to reduce diarrhea in SBS by modulating chloride ion secretion without affecting gut movement or interacting with other drugs. Participants will receive crofelemer as a powder taken orally three times daily for 12 weeks, followed by a 4-week follow-up period. This open-label pilot study provides crofelemer to all enrolled patients without placebo or comparator groups. The treatments impact on reducing ostomy output and parenteral support needs will be assessed. The study monitors changes in fluid and nutrient absorption, quality of life, gastrointestinal symptoms, and electrolyte requirements during and after the treatment period. During the study, participants will have regular assessments including measurements of ostomy output, parenteral support volume, and quality of life questionnaires. Researchers will also evaluate gastrointestinal symptoms and intestinal absorption improvements. Safety will be monitored through medical exams and laboratory tests. Participants are expected to maintain stable parenteral support before and during the trial and to comply with scheduled visits. The total study duration for each participant is approximately 16 weeks from treatment start to follow-up.

Open-Label Pilot Study With Crofelemer in Patients With Short Bowel Syndrome