Could a Plant-Based drug cut IV nutrition needs for short bowel patients?
NCT ID NCT06326645
First seen Jun 26, 2026 · Last updated Aug 20, 2026 · Updated 3 times
Summary
This early-phase pilot study is testing a drug called crofelemer in 6 adults with short bowel syndrome who have an ileostomy and need IV nutrition. The goal is to see if crofelemer can reduce ostomy output and the amount of IV support needed over 12 weeks. Participants take the drug as a powder three times daily, with a 4-week follow-up after treatment ends.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Crofelemer (oral powder)
- What this could lead to
- If it works, this could point toward a new way to reduce diarrhea and the need for IV nutrition in people with short bowel syndrome.
- What could go wrong
- This is a very early, small pilot study with only 6 people. It may not show clear benefit, and results may not apply to all patients. Side effects are not yet well understood.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
-
About 6 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Cleveland Clinic Main Campus
Cleveland, Ohio, 44106, United States
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Other studies related to the condition(s) this trial covers.
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