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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Lindsey Russell, MD
Study ID
NCT06326645
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Short Bowel Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Crofelemer Oral Product — DRUG
    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)

Study Details

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. .

Key Dates

Start date
Mar 3, 2025
Status verified
Feb 2026
Primary completion
Feb 1, 2026
Completion
Feb 1, 2026

Study Design

Enrollment
6 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Crofelemer Group

Primary Outcome Measure

Ostomy output reduction [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland Clinic Main CampusClevelandOhio44106
Lindsey A Russell, MD

Find similar trials in Cleveland, OH

By research site
Cleveland Clinic Main Campus· Cleveland, OH

Related Studies