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
N/A
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
This research aims to evaluate the effectiveness and safety of crofelemer treatment in adults with Short Bowel Syndrome (SBS) who have an ileostomy and rely on parenteral support (PS). SBS occurs when less than 200 cm of small bowel remains, leading to poor absorption of nutrients and fluids and causing severe diarrhea that impacts health and quality of life. Current diarrhea management in SBS is challenging and involves multiple medications, but better treatments are needed. Crofelemer, an FDA-approved drug for HIV-associated diarrhea, is being studied for its potential to reduce diarrhea in SBS by modulating chloride ion secretion without affecting gut movement or interacting with other drugs. Participants will receive crofelemer as a powder taken orally three times daily for 12 weeks, followed by a 4-week follow-up period. This open-label pilot study provides crofelemer to all enrolled patients without placebo or comparator groups. The treatment’s impact on reducing ostomy output and parenteral support needs will be assessed. The study monitors changes in fluid and nutrient absorption, quality of life, gastrointestinal symptoms, and electrolyte requirements during and after the treatment period. During the study, participants will have regular assessments including measurements of ostomy output, parenteral support volume, and quality of life questionnaires. Researchers will also evaluate gastrointestinal symptoms and intestinal absorption improvements. Safety will be monitored through medical exams and laboratory tests. Participants are expected to maintain stable parenteral support before and during the trial and to comply with scheduled visits. The total study duration for each participant is approximately 16 weeks from treatment start to follow-up.
CONDITIONS
Brief 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 understand and provide written informed consent and be willing to complete required assessments
- Male and female patients aged 18 years or older
- SBS patients without colon in continuity
- History of SBS causing intestinal failure due to major bowel resection, stable regarding parenteral support need
- At least 6 months since last bowel surgery
- No restorative surgery planned during study period
- At least 6 continuous months of parenteral support dependency
- Receiving stable parenteral support at least three times per week with no major changes for 12 weeks
- Patients with Crohn's disease must be in clinical remission for at least 12 weeks
- Ability to eat solid or semi-solid foods and drink fluids
- Women of childbearing potential must use highly effective birth control throughout the study
- Negative pregnancy test required before first drug dose for women of childbearing potential
- Male patients must agree to use birth control during study and for 30 days after last dose
- Satisfactory general health as determined by medical history and physical exam
You will not qualify if you...
- Body mass index less than 17.5 or greater than 30 kg/m2
- Significant intestinal adhesions or chronic abdominal pain interfering with study
- Active infection, fever over 100°F, or symptoms of upper respiratory infection
- Radiological signs of significant bowel dilation or pseudo-obstruction
- Active Crohn's disease
- Recent changes in immunosuppressant or biologic therapy for inflammatory bowel disease
- Planned major surgery during the study
- Visible blood in stool within last 3 months
- Ongoing radiation enteritis or damaged enteral tissue from specific conditions
- Compromised immune system
- Inadequate liver or kidney function as defined by lab tests
- Urine sodium less than 20 mmol/day
- More than four SBS-related hospital admissions in past 12 months or admission within 1 month before screening
- Previous use or allergies to crofelemer
- Recent use of certain biologics, corticosteroids, or related therapies
- Use of antimotility, antidiarrheal, or acid-reducing agents not stable for 4 weeks prior and during study
- Recent antibiotic use except for specific reasons
- Alcohol or drug abuse within past year
- Pregnant or breastfeeding women
- History of malignancy within past year
- History of psychiatric illness
- Other uncontrolled chronic or acute diseases contraindicating participation
- Inability or unwillingness to follow study schedules and procedures
- Participation in another interventional trial within 30 days prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 16 weeks
Participants receive Crofelemer, an anti-diarrheal drug, to assess its effectiveness in reducing diarrhea associated with short bowel syndrome while continuing their stable parenteral support.
Weekly visits for up to 16 weeks
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
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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