Could a Plant-Based powder cut the need for IV nutrition?
NCT ID NCT06904872
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests crofelemer, a plant-based oral powder, in 18 adults with short bowel syndrome and intestinal failure who rely on IV nutrition. Participants receive either a low dose, a higher dose, or a placebo for 24 weeks. The goal is to see if crofelemer safely reduces the amount of IV nutrition and stool volume needed.
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, crofelemer could help reduce the amount of IV nutrition needed for people with short bowel syndrome, improving daily life.
- What could go wrong
- This is a small, early-phase trial with only 18 participants, so results may not apply to everyone. The drug may not work better than placebo.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 18 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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
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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 Patients will be enrolled in the study if they meet all the following criteria: 1. Patients must understand and provide written informed consent before they can participate in the study. They must understand the study procedures and be willing to complete the required assessments; 2. Male and female patients aged ≥ 18 years; 3. SBS patients with intestinal failure and without colon-in-continuity who are not eligible or not willing to receive an approved marketed GLP-2; 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) without colon-in-continuity (patients with duodenostomy, Jejunostomy or Ileostomy). Intestinal failure will be defined according to the recommendations of the European Society for Clinical Nutrition and Metabolism (ESPEN), 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. \*Patients with history of cancer, should be in remission for the last 6 months and with not ongoing anticancer therapy (long-term hormonal therapy is allowed). 5. Minimum remaining length of 60 cm of small bowel; 6. At least 6 months elapsed since last surgical bowel resection; 7. No restorative surgery planned during the entire study period; 8. Patients with at least 4 continuous months of PS dependency (parenteral nutrition with or without intravenous fluids); 9. Chronic non-infectious diarrhoea defined as passage of at least 1 loose watery stool per day for more than 4 consecutive weeks. 10. Patients receiving parenteral support (fluids, electrolytes and/or nutrients) for at least three days per week and a minimum of 6 liters of PS per week, to meet caloric, fluid or electrolytes needs; 11. Patients with Crohn's disease will have to be in clinical remission for ≥ 12 weeks; 12. Patients must be able to ingest solid or semi-solid foods and drink fluids; 13. If taken at screening, use of antimotility and antidiarrheal agents (loperamide, diphenoxylate, 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; 14. If female and of child-bearing potential, the patient must use an "acceptable effective contraceptive measure" for the entire study duration and for 4 weeks after the last dose. Acceptable birth control methods that result in a failure rate of more than 1% per year include: progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action male or female condom with or without spermicide cap, diaphragm or sponge with spermicide (A combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods) are also considered acceptable). Male patients must agree to use an acceptable form of birth control and to not donate sperm during the study and for 4 weeks after the last dose. 15. If female and child-bearing potential, the patient must have a negative urine pregnancy test prior the first administration of the investigational product; 16. Satisfactory general health status as determined by the investigator based on current medical status, medical history and physical examination. Exclusion criteria Patients cannot be enrolled in the study if they meet any of the following criteria: 1. Diagnosis of celiac disease or active or refractory tropical sprue; 2. Presence of clinically significant intestinal adhesions and/or chronic abdominal pain that can interfere with the conduct of the study; 3. Patients with current radiological (Radiography and/or CT) evidence of bowel dilatation or pseudo-obstruction; 4. Active Crohn's disease as evaluated by standard procedures employed by the investigator; 5. 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; 6. Intestinal or other major surgery scheduled within the time frame of the study; 7. Visible blood in the stool within the last 12 weeks; 8. Clinical evidence of active radiation enteritis or scleroderma, contributing to the patient's stool volume; 9. Compromised immune system (e.g., acquired immune deficiency syndrome \[AIDS\], severe combined immunodeficiency); 10. Inadequate hepatic function: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) and/or total bilirubin and/or alkaline phosphatases \> 2 times the patient's average relative values in the last 3 months; 11. Inadequate renal function: serum creatinine or blood urea nitrogen \> 2 times the Upper Normal Limit (UNL); 12. Urine sodium \<20 mmol/day; 13. 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 the last 4 weeks; 14. Concurrent or past 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; 15. Use of systemic corticosteroids, methotrexate, cyclosporine, tacrolimus, sirolimus, octreotide, intravenous glutamine within the last 4 weeks; 16. Use of antibiotics within the last week or active infection; 17. History of alcohol abuse (Drinking more than 12 g/day of alcohol for women and 24 g/day of alcohol for men) or drug abuse within the last year; 18. Pregnant or lactating women; 19. History of psychiatric illnesses which lead to consider the patient as incapacitated and prevent him/her to provide informed consent; 20. 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; 21. Patient not capable of understanding or not willing to adhere to the study visit schedules and other protocol requirements; 22. Participation in any other interventional clinical study within five times the half-life of the investigational medicinal product / relevant metabolites (of the previous clinical study) or 4 weeks (whichever is longer) prior to screening; 23. Known hypersensitivity/allergy to ANY component of the IP.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
8 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Asklepios Klinik St. Georg
RECRUITINGHamburg, 20099, Germany
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Azienda Ospedaliera Universitaria Federico II
RECRUITINGNaples, 80131, Italy
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Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
RECRUITINGBologna, 40138, Italy
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Charité Universitätsmedizin
RECRUITINGBerlin, 10117, Germany
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Ospedale Università di Padova
RECRUITINGPadova, 35128, Italy
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Universitäatsklinik RWTH
RECRUITINGAachen, 52074, Germany
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Universitätsklinikum
RECRUITINGEssen, 45147, Germany
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Universitätsmedizin
RECRUITINGRostock, 18057, Germany
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