Open-Label Pilot Study With Crofelemer in Patients With Short Bowel Syndrome
Lindsey Russell, MD
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. .
Description
Short bowel syndrome (SBS) is defined as less than 200 cm in adults of remaining small bowel (i.e. excluding colon) in continuity leading to the need for nutritional and fluid supplements due to impaired absorption of nutrients, electrolytes and fluids. Most patients with SBS experience debilitating diarrhea that severely hinders their health outcomes and quality of life. SBS-associated diarrhea may have several etiologies including excessive secretion and/or impaired absorption of fluid and electrolytes across the intestinal epithelium. Diarrhea can lead to dehydration, electrolyte imbalance…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. 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; 2. Male and female patients aged ≥ 18 years; 3. SBS patients without colon in continuity: 4. 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…
Interventions
- DrugCrofelemer Oral Product
Crofelemer powder for solution (50g and 100g) or Crofelemer Powder for Oral Solution (100 mg/mL or 30 mg/mL vials for reconstitution and oral dosing)
Location
- Cleveland Clinic Main CampusCleveland, Ohio