Clinical Trial

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

Study acronym: CRO-SBS-IF
Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
A 24-week, randomized, placebo-controlled, double-blind study to evaluate the efficacy, safety and tolerability of crofelemer in patients with Short Bowel Syndrome and Intestinal Failure (SBS-IF) without colon-in-continuity (CIC) requiring parenteral support (PS). Blinded study drug will be administered orally (or enterally) three times daily (TID) as a novel crofelemer formulation, Crofelemer Powder for Oral Solution, or a matching placebo powder formulation for oral solution. Patients will be randomized in a 1:1:1 ratio to crofelemer 3 mg/kg/dose TID, crofelemer 10 mg/kg/dose TID or placebo.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-03-25; most recent amendment 2026-06-05.
Status change: Not Yet Recruiting → Recruiting 2025-06-09
Trial Details
NCT Number NCT06904872
Lead Sponsor Napo Therapeutics, S.p.A.
Conditions Short Bowel Syndrome, Malabsorption Syndromes, Short Gut Syndrome, Post-Op Complication, Functional Gastrointestinal Disorders
Enrollment 18 participants
Start Date 2025-05-29
Primary Completion 2027-03 (estimated)
Study Completion 2027-03 (estimated)
Updated on ClinicalTrials.gov 2026-06-09