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

NCT06326645 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-02-12

No results posted yet for this study

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. .

Conditions

  • Short Bowel Syndrome

Interventions

DRUG

Crofelemer 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)

Sponsors & Collaborators

  • Napo Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Lindsey Russell, MD

    lead OTHER

Principal Investigators

  • Lindsey Russell · The Cleveland Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-03
Primary Completion
2026-02-01
Completion
2026-02-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06326645 on ClinicalTrials.gov