Actively Recruiting
Safety and Efficacy of Crofelemer in Adult Patients With Short Bowel Syndrome and Intestinal Failure (SBS-IF) Without Colon-in-continuity (CIC)
Led by Napo Therapeutics, S.p.A. · Updated on 2025-06-12
18
Participants Needed
8
Research Sites
35 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A 24-week, randomized, placebo-controlled, double-blind study to evaluate the efficacy, safety and tolerability of crofelemer in patients with Short Bowel Syndrome and Intestinal Failure (SBS-IF) without colon-in-continuity (CIC) requiring parenteral support (PS). Blinded study drug will be administered orally (or enterally) three times daily (TID) as a novel crofelemer formulation, Crofelemer Powder for Oral Solution, or a matching placebo powder formulation for oral solution. Patients will be randomized in a 1:1:1 ratio to crofelemer 3 mg/kg/dose TID, crofelemer 10 mg/kg/dose TID or placebo and randomization will be stratified by baseline PS volume (≤4 or \>4 L/week).
CONDITIONS
Official Title
Safety and Efficacy of Crofelemer in Adult Patients With Short Bowel Syndrome and Intestinal Failure (SBS-IF) Without Colon-in-continuity (CIC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must understand and provide written informed consent.
- Male and female patients aged 18 years or older.
- Patients with Short Bowel Syndrome and intestinal failure without colon-in-continuity not eligible or unwilling to receive approved GLP-2.
- History of SBS caused by major intestinal resection without colon-in-continuity, with intestinal failure requiring intravenous supplementation.
- Minimum remaining small bowel length of 100 cm.
- At least 6 months since last surgical bowel resection.
- No planned restorative surgery during the study.
- At least 4 continuous months of parenteral support dependency.
- Chronic non-infectious diarrhea with at least 1 loose watery stool per day for more than 4 weeks.
- Receiving stable parenteral support at least 3 days per week with minimum 2 liters per week.
- Patients with Crohn's disease must be in clinical remission for at least 12 weeks.
- Able to ingest solid or semi-solid foods and drink fluids.
- Stable doses of certain medications for at least 4 weeks prior to screening.
- Women of child-bearing potential must use effective contraception during and 4 weeks after the study.
- Negative urine pregnancy test before first dose for women of child-bearing potential.
- Satisfactory general health based on medical evaluation.
You will not qualify if you...
- Body mass index less than 17.5 or greater than 30 kg/m2.
- Clinically significant intestinal adhesions or chronic abdominal pain interfering with the study.
- Radiological signs of bowel dilatation or pseudo-obstruction.
- Active Crohn's disease.
- Recent immunosuppressant therapy or biologics for inflammatory bowel disease.
- Scheduled intestinal or major surgery during the study.
- Visible blood in stool within the last 12 weeks.
- Ongoing radiation enteritis or damaged enteral tissue.
- Compromised immune system.
- Inadequate liver or kidney function.
- Urine sodium less than 20 mmol/day.
- More than four SBS-related hospital admissions in the past 12 months or recent admission within 4 weeks.
- Recent use of certain biologic or systemic therapies.
- Use of antibiotics within the last week or active infection.
- History of alcohol or drug abuse within the last year.
- Pregnant or breastfeeding women.
- Psychiatric illness preventing informed consent.
- Other uncontrolled chronic or acute diseases affecting participation.
- Unable or unwilling to follow study visits and requirements.
- Participation in another interventional clinical study within relevant time frames.
- Known allergy to any study medication component.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Universitäatsklinik RWTH
Aachen, Germany, 52074
Not Yet Recruiting
2
Charité Universitätsmedizin
Berlin, Germany, 10117
Not Yet Recruiting
3
Universitätsklinikum
Essen, Germany, 45147
Not Yet Recruiting
4
Asklepios Klinik St. Georg
Hamburg, Germany, 20099
Not Yet Recruiting
5
Universitätsmedizin
Rostock, Germany, 18057
Not Yet Recruiting
6
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
Bologna, Italy, 40138
Actively Recruiting
7
Azienda Ospedaliera Universitaria Federico II
Naples, Italy, 80131
Actively Recruiting
8
Ospedale Università di Padova
Padova, Italy, 35128
Not Yet Recruiting
Research Team
S
Sabriye Duran
CONTACT
S
Sara Papetti, MA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here