Open-Label Pilot Study With Crofelemer in Patients With Short Bowel Syndrome (NCT06326645) | Clinical Trial Compass
RecruitingEarly Phase 1
Open-Label Pilot Study With Crofelemer in Patients With Short Bowel Syndrome
United States6 participantsStarted 2025-03-03
Plain-language summary
The objectives of this study are to evaluate the efficacy and safety of crofelemer treatment in adults affected by Short Bowel Syndrome (SBS) with an ileostomy on parenteral support (PS) in reducing output or PS needs. Crofelemer will be provided as a powder three times daily for 12 weeks and a 4 week follow up. .
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients must understand and provide written informed consent before they can participate in the study. They must understand the study procedures of the trial and be willing to complete the required assessments;
✓. Male and female patients aged ≥ 18 years;
✓. SBS patients without colon in continuity:
✓. Patients with history of SBS resulting in intestinal failure caused by a major intestinal resection (e.g., injury, cancer, Crohn's disease, vascular disease, volvulus, intussusceptions or other causes). Diagnosis of SBS will be defined as remaining small bowel excluding colon in continuity and considered stable with regard to parenteral support (PS) need. Intestinal failure will be defined according to the recommendations of the American Society of Parenteral and Enteral Nutrition (ASPEN), i.e. a reduction of gut function below the minimum necessary for the absorption of macronutrients and/or water and electrolytes, such that intravenous (IV) supplementation is required to maintain health and/or growth;
✓. At least 6 months elapsed since last surgical bowel resection;
✓. No restorative surgery planned in the overall study period;
✓. Patients with at least 6 continuous months of PS dependency (parenteral nutrition and/or intravenous fluids) before entry in the study;
✓. Patients receiving stable PS (fluids, electrolytes or nutrients) at least three times per week to meet caloric, fluid or electrolytes needs with no major changes in provisions for at least 12 weeks;
✕. Presence of clinically significant intestinal adhesions and/or chronic abdominal pain that can interfere with the conduct of the study;
✕. Presence of confirmed active infection, temperatures \>100°Farenheit, or symptoms of an upper respiratory infection
✕. Patients with Radiological (Radiography and/or CT) signs of significant bowel dilatation or pseudo-obstruction;
✕. Active Crohn's disease as evaluated by standard procedures employed by the investigator;
✕. Inflammatory bowel disease (IBD) that required immunosuppressant therapy that has been introduced or changed within last 3 months or treatment with biologics within the last 6 months;
✕. Intestinal or other major surgery scheduled within the time frame of the study;
✕. Visible blood in the stool within the last 3 months;