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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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. .

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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;

• Patients with Crohn's disease will have to be in clinical remission for ≥ 12 weeks before entry in the study;

⁃ Patients must be able to ingest solid or semi-solid foods and drink fluids;

⁃ If female and of child-bearing potential, the patient use a highly effective method of birth control for the entire study duration. Highly effective birth control methods include: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomized partner; sexual abstinence;

⁃ If female and of child-bearing potential, the patient must have a negative urine pregnancy test prior the first administration of the study drugs;

⁃ Male patients must agree to use an acceptable form of birth control during the study and for 30 days after the last dose;

⁃ Satisfactory general health status as determined by the investigator based on medical history and physical examination

Locations
United States
Ohio
Cleveland Clinic Main Campus
RECRUITING
Cleveland
Contact Information
Primary
Kaylyn McClough
mcclouk@ccf.org
(216) 444-1122
Time Frame
Start Date: 2025-03-03
Estimated Completion Date: 2026-02-01
Participants
Target number of participants: 6
Treatments
Experimental: Crofelemer Group
Related Therapeutic Areas
Sponsors
Leads: Lindsey Russell, MD
Collaborators: Napo Pharmaceuticals, Inc.

This content was sourced from clinicaltrials.gov