Actively Recruiting
Open-Label Pilot Study With Crofelemer in Patients With Short Bowel Syndrome
Led by Lindsey Russell, MD · Updated on 2026-02-12
6
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
Sponsors
L
Lindsey Russell, MD
Lead Sponsor
N
Napo Pharmaceuticals, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Open-Label Pilot Study With Crofelemer in Patients With Short Bowel Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must provide written informed consent and understand study procedures
- Male and female patients aged 18 years or older
- SBS patients without colon in continuity
- History of SBS causing intestinal failure due to major intestinal resection
- At least 6 months since last bowel surgery
- No planned restorative surgery during the study
- At least 6 continuous months of parenteral support dependency
- Stable parenteral support at least three times per week for 12 weeks
- Patients with Crohn's disease must be in remission for at least 12 weeks
- Ability to ingest solid or semi-solid foods and drink fluids
- Females of child-bearing potential must use highly effective birth control during study
- Negative pregnancy test before first drug dose for females of child-bearing potential
- Male patients must use birth control during study and 30 days after last dose
- Satisfactory general health based on medical history and physical exam
You will not qualify if you...
- Body mass index (BMI) less than 17.5 or greater than 30 kg/m2
- Clinically significant intestinal adhesions or chronic abdominal pain interfering with study
- Active infection, fever over 100°F, or upper respiratory infection symptoms
- Radiological signs of significant bowel dilatation or pseudo-obstruction
- Active Crohn's disease
- Recent immunosuppressant or biologic therapy for inflammatory bowel disease
- Scheduled major surgery during study
- Visible blood in stool within last 3 months
- Ongoing radiation enteritis or damaged enteral tissue from certain diseases
- Compromised immune system (e.g., AIDS)
- Inadequate liver or kidney function based on lab tests
- Urine sodium less than 20 mmol/day
- More than four SBS-related hospital admissions in past 12 months or recent admission
- Previous use or allergy to crofelemer
- Recent use of certain biological therapies, corticosteroids, or octreotide
- Stable use of certain medications required before and during study
- Recent antibiotic use unless for line sepsis or dental procedure
- Alcohol or drug abuse within past year
- Pregnant or breastfeeding women
- Cancer diagnosis within past year
- History of psychiatric illness
- Other uncontrolled chronic or acute diseases contraindicating participation
- Unable or unwilling to comply with study schedule
- Participation in another interventional study within 30 days before screening
AI-Screening
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Trial Site Locations
Total: 1 location
1
Cleveland Clinic Main Campus
Cleveland, Ohio, United States, 44106
Actively Recruiting
Research Team
L
Lindsey Reardon, AS, BA, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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