NCT06326645 Open-Label Pilot Study With Crofelemer in Patients With Short Bowel Syndrome
| NCT ID | NCT06326645 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Lindsey Russell, MD |
| Condition | Short Bowel Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 6 participants |
| Start Date | 2025-03-03 |
| Primary Completion | 2026-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 6 participants in total. It began in 2025-03-03 with a primary completion date of 2026-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. .
Eligibility Criteria
Inclusion Criteria: 1. Patients must understand and provide written informed consent before they can participate in the study. They must understand the study procedures of the trial and be willing to complete the required assessments; 2. Male and female patients aged ≥ 18 years; 3. SBS patients without colon in continuity: 4. Patients with history of SBS resulting in intestinal failure caused by a major intestinal resection (e.g., injury, cancer, Crohn's disease, vascular disease, volvulus, intussusceptions or other causes). Diagnosis of SBS will be defined as remaining small bowel excluding colon in continuity and considered stable with regard to parenteral support (PS) need. Intestinal failure will be defined according to the recommendations of the American Society of Parenteral and Enteral Nutrition (ASPEN), i.e. a reduction of gut function below the minimum necessary for the absorption of macronutrients and/or water and electrolytes, such that intravenous (IV) supplementation is required to maintain health and/or growth; 5. At least 6 months elapsed since last surgical bowel resection; 6. No restorative surgery planned in the overall study period; 7. Patients with at least 6 continuous months of PS dependency (parenteral nutrition and/or intravenous fluids) before entry in the study; 8. Patients receiving stable PS (fluids, electrolytes or nutrients) at least three times per week to meet caloric, fluid or electrolytes needs with no major changes in provisions for at least 12 weeks; 9. Patients with Crohn's disease will have to be in clinical remission for ≥ 12 weeks before entry in the study; 10. Patients must be able to ingest solid or semi-solid foods and drink fluids; 11. If female and of child-bearing potential, the patient use a highly effective method of birth control for the entire study duration. Highly effective birth control methods include: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomized partner; sexual abstinence; 12. If female and of child-bearing potential, the patient must have a negative urine pregnancy test prior the first administration of the study drugs; 13. Male patients must agree to use an acceptable form of birth control during the study and for 30 days after the last dose; 14. Satisfactory general health status as determined by the investigator based on medical history and physical examination Exclusion Criteria: 1. Body mass index (BMI) \<17.5 or \>30 kg/m2; 2. Presence of clinically significant intestinal adhesions and/or chronic abdominal pain that can interfere with the conduct of the study; 3. Presence of confirmed active infection, temperatures \>100°Farenheit, or symptoms of an upper respiratory infection 4. Patients with Radiological (Radiography and/or CT) signs of significant bowel dilatation or pseudo-obstruction; 5. Active Crohn's disease as evaluated by standard procedures employed by the investigator; 6. Inflammatory bowel disease (IBD) that required immunosuppressant therapy that has been introduced or changed within last 3 months or treatment with biologics within the last 6 months; 7. Intestinal or other major surgery scheduled within the time frame of the study; 8. Visible blood in the stool within the last 3 months; 9. Ongoing radiation enteritis or the presence of damaged enteral tissue due to radiation enteritis, scleroderma, celiac disease, refractory or tropical sprue; 10. Compromised immune system (e.g., acquired immune deficiency syndrome \[AIDS\], severe combined immunodeficiency); 11. Inadequate hepatic function: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>2 upper limit of normal (ULN), total bilirubin \>1.25 ULN or alkaline phosphatases \>2.5 ULN; 12. Inadequate renal function: serum creatinine or blood urea nitrogen \>1.5 ULN; 13. Urine sodium \<20 mmol/day; 14. More than four SBS-related hospital admissions (unless one or more admissions were to rule out line sepsis) within the past 12 months or hospital admission within 1 month before screening; 15. Previous use of Crofelemer or potential allergies to Crofelemer or its constituents; 16. Use of infliximab, growth hormone or growth factors such as native glucagon-like peptide-2 (GLP-2) or other biological therapy within the last 12 weeks; 17. Current or past use of teduglutide within the last 3 months; 18. Use of systemic corticosteroids, methotrexate, cyclosporine, tacrolimus, sirolimus, octreotide, intravenous glutamine within the last 30 days; 19. If taken at screening, use of antimotility and antidiarrheal agents (loperamide, difenoxylate, codeine and other opiates), H2-receptor antagonists, proton pump inhibitors, bile sequestering agents, oral glutamine, diuretics and oral rehydration solutions is required to be at stable average weekly doses for at least 4 weeks prior to screening evaluations and to remain stable for the entire study duration; 20. Use of antibiotics within the last 30 days unless they were administered while ruling out line sepsis or for a dental procedure; 21. Alcohol or drug abuse within the last year; 22. Pregnant or lactating women; 23. History of any malignancy in the past 1 year; 24. History of psychiatric illnesses; 25. History of any other uncontrolled chronic or acute concomitant disease which, in the Investigator's opinion, would contraindicate study participation or confound interpretation of the results; 26. Patient not capable of understanding or not willing to adhere to the study visit schedules and other protocol requirements; 27. Participation in any other interventional clinical study within 30 days prior to the screening visit.
Contact & Investigator
Lindsey Russell
PRINCIPAL INVESTIGATOR
The Cleveland Clinic
Frequently Asked Questions
Who can join the NCT06326645 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Short Bowel Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06326645 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06326645 currently recruiting?
Yes, NCT06326645 is actively recruiting participants. Contact the research team at reardol3@ccf.org for enrollment information.
Where is the NCT06326645 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT06326645 clinical trial?
NCT06326645 is sponsored by Lindsey Russell, MD. The principal investigator is Lindsey Russell at The Cleveland Clinic. The trial plans to enroll 6 participants.