RecruitingEarly Phase 1NCT06326645

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

Sponsor

Lindsey Russell, MD

Enrollment

6 participants

Start Date

Mar 3, 2025

Study Type

INTERVENTIONAL

Conditions

Short Bowel Syndrome

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Crofelemer Oral Product for people with short bowel syndrome. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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)

Locations(1)

Cleveland Clinic Main Campus

Cleveland, Ohio, United States

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NCT06326645

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