Crofelemer for Short Bowel Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
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. .
Will I have to stop taking my current medications?
The trial requires that certain medications be stable for at least 4 weeks before starting and remain stable during the study. Some medications, like systemic corticosteroids and certain biologics, must not have been used recently. Check with the study team about your specific medications.
How does the drug Crofelemer differ from other treatments for short bowel syndrome?
Crofelemer is unique because it is primarily used to manage diarrhea by regulating fluid secretion in the intestines, which may help in conditions like short bowel syndrome where fluid balance is crucial. Unlike other treatments that focus on promoting intestinal growth or adaptation, Crofelemer's mechanism targets the symptoms directly.12345
Who Is on the Research Team?
Lindsey Russell
Principal Investigator
The Cleveland Clinic
Are You a Good Fit for This Trial?
This trial is for adults with Short Bowel Syndrome who have an ileostomy and rely on parenteral support. Participants should be able to take crofelemer powder three times daily for 12 weeks, followed by a 4-week follow-up period.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Crofelemer as a powder three times daily for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Crofelemer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Lindsey Russell, MD
Lead Sponsor
Napo Pharmaceuticals, Inc.
Industry Sponsor