Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID06904872
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Two Doses of Crofelemer in Adults With Short Bowel Syndrome and Intestinal Failure Without Colon-in-Continuity
Led by Napo Therapeutics, S.p.A. · Updated on 2025-06-12
18
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of crofelemer on adults with Short Bowel Syndrome and Intestinal Failure (SBS-IF) who do not have colon-in-continuity and require parenteral support. This randomized, placebo-controlled, double-blind Phase 2 study aims to evaluate the efficacy, safety, and tolerability of crofelemer in this patient group. Participants must meet specific health criteria including stable parenteral support and a history of chronic non-infectious diarrhea. During the study, participants are randomly assigned to one of three groups: crofelemer 3 mg/kg/dose, crofelemer 10 mg/kg/dose, or a matching placebo. The study drug, given orally or enterally, is administered three times daily for 24 weeks. Before treatment, there is a screening period of up to 4 weeks and a parenteral support stabilization period lasting 2 to 12 weeks. Following the treatment period, participants will be monitored for an additional 4 weeks to assess safety. Participants will visit the study site at baseline and at weeks 1, 2, 4, 8, 12, 16, 20, and 24 during the treatment phase. Assessments include monitoring safety and tolerability, changes in parenteral support volume and intake, stool consistency and volume, laboratory tests, and physical examinations. The study will compare outcomes between the crofelemer doses and placebo over the 24-week treatment period to assess preliminary efficacy and safety.
CONDITIONS
Brief 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
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Able to understand and provide written informed consent
- Age 18 years or older
- Diagnosis of Short Bowel Syndrome with intestinal failure without colon-in-continuity
- History of major intestinal resection causing intestinal failure
- Minimum remaining small bowel length of 100 cm
- At least 6 months since last surgical bowel resection
- No planned restorative surgery during the study
- Dependent on parenteral support for at least 4 continuous months
- Chronic non-infectious diarrhea for more than 4 weeks
- Stable parenteral support at least 3 days per week with minimum 2 liters per week
- Clinical remission of Crohn's disease for at least 12 weeks if applicable
- Ability to ingest solid or semi-solid foods and fluids
- Stable doses of certain medications for at least 4 weeks before screening
- Use of effective contraception during study and for 4 weeks after if of child-bearing potential
- Negative pregnancy test before first dose if applicable
- Satisfactory general health based on medical assessment
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
- Radiological signs of bowel dilatation or pseudo-obstruction
- Active Crohn's disease
- Recent changes in immunosuppressive therapy or biologics within past 3 to 6 months
- Scheduled major surgery during the study
- Visible blood in stool in last 12 weeks
- Ongoing radiation enteritis or certain intestinal diseases
- Compromised immune system
- Poor liver or kidney function as defined by lab tests
- Low urine sodium less than 20 mmol/day
- More than four SBS-related hospital admissions in past year or recent admission
- Recent use of certain biological therapies or medications
- Antibiotic use within last week or active infection
- History of alcohol or drug abuse within last year
- Pregnant or breastfeeding
- Psychiatric illness preventing informed consent
- Other uncontrolled diseases that may affect study
- Inability or unwillingness to follow study schedule
- Participation in another interventional study recently
- Known allergy to study drug components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - Up to 4 weeks
Participants are screened for eligibility to participate in the trial.
Visits occur during this period to assess eligibility and stabilize parenteral support.
Parenteral Support Stabilization
Duration - 2 to 12 weeks
Participants undergo a stabilization period for parenteral support to meet trial requirements before randomization.
Visits occur as needed to ensure stable parenteral support.
Treatment
Duration - 24 weeks
Participants receive crofelemer or placebo three times daily to evaluate safety, tolerability, and efficacy.
Visits at baseline and after 1, 2, 4, 8, 12, 16, 20, and 24 weeks of treatment
Follow-up
Duration - 4 weeks
Participants are monitored for safety after completing the treatment period.
Visits occur to assess safety during this follow-up period
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
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Research Team
S
Sabriye Duran
S
Sara Papetti, MA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Published Research Related To This Trial
Short bowel syndrome: epidemiology and etiology.
Paul W Wales, Emily R Christison-Lagay
https://pubmed.ncbi.nlm.nih.gov/20123268Short-bowel syndrome in children and adults.
J A Vanderhoof, A N Langnas
https://pubmed.ncbi.nlm.nih.gov/9352883Crofelemer, an antisecretory antidiarrheal proanthocyanidin oligomer extracted from Croton lechleri, targets two distinct intestinal chloride channels.
Lukmanee Tradtrantip, Wan Namkung, A S Verkman
https://pubmed.ncbi.nlm.nih.gov/19808995Short Bowel Syndrome and Malabsorption - Causes and Prevention.
Jon S Thompson
https://pubmed.ncbi.nlm.nih.gov/26288591Update in pathogenesis and prospective in treatment of necrotizing enterocolitis.
Gianluca Terrin, Antonella Scipione, Mario De Curtis
https://pubmed.ncbi.nlm.nih.gov/25147804Pathophysiology of short bowel syndrome: considerations of resected and residual anatomy.
Kelly A Tappenden
https://pubmed.ncbi.nlm.nih.gov/24500909Mortality and economics in short bowel syndrome.
J Schalamon, J M Mayr, M E Höllwarth
https://pubmed.ncbi.nlm.nih.gov/14642858ESPEN guidelines on chronic intestinal failure in adults.
Loris Pironi, Jann Arends, Federico Bozzetti...
https://pubmed.ncbi.nlm.nih.gov/26944585Managing the Adult Patient With Short Bowel Syndrome.
Carol Rees Parrish, John K DiBaise
https://pubmed.ncbi.nlm.nih.gov/29230136