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Short Bowel SyndromePhase 2CRO-SBS-IFNCT06904872

Safety and Efficacy of Crofelemer in Adult Patients With Short Bowel Syndrome and Intestinal Failure (SBS-IF) Without Colon-in-continuity (CIC)

A Phase 2 study testing Crofelemer Powder for Oral Solution in people with Short Bowel Syndrome and Malabsorption Syndromes, run by Napo Therapeutics, S.p.A. at 8 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Crofelemer Powder for Oral Solution
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
18 participants
Where
8 sitesin 2 countries
Study dates
29 May 2025to Mar 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients will be enrolled in the study if they meet all the following criteria:
  • 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;
  • Male and female patients aged ≥ 18 years;
  • SBS patients with intestinal failure and without colon-in-continuity who are not eligible or not willing to receive an approved marketed GLP-2;
  • 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).
  • Minimum remaining length of 60 cm of small bowel;
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  • At least 6 months elapsed since last surgical bowel resection;
  • No restorative surgery planned during the entire study period;
  • Patients with at least 4 continuous months of PS dependency (parenteral nutrition with or without intravenous fluids);
  • Chronic non-infectious diarrhoea defined as passage of at least 1 loose watery stool per day for more than 4 consecutive weeks.
  • 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;
  • Patients with Crohn's disease will have to be in clinical remission for ≥ 12 weeks;
  • Patients must be able to ingest solid or semi-solid foods and drink fluids;
  • 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;
  • 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.
  • If female and child-bearing potential, the patient must have a negative urine pregnancy test prior the first administration of the investigational product;
  • Satisfactory general health status as determined by the investigator based on current medical status, medical history and physical examination.

Who cannot join

  • Patients cannot be enrolled in the study if they meet any of the following criteria:
  • Diagnosis of celiac disease or active or refractory tropical sprue;
  • Presence of clinically significant intestinal adhesions and/or chronic abdominal pain that can interfere with the conduct of the study;
  • Patients with current radiological (Radiography and/or CT) evidence of bowel dilatation or pseudo-obstruction;
  • Active Crohn's disease as evaluated by standard procedures employed by the investigator;
  • 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;
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  • Intestinal or other major surgery scheduled within the time frame of the study;
  • Visible blood in the stool within the last 12 weeks;
  • Clinical evidence of active radiation enteritis or scleroderma, contributing to the patient's stool volume;
  • Compromised immune system (e.g., acquired immune deficiency syndrome [AIDS], severe combined immunodeficiency);
  • 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;
  • Inadequate renal function: serum creatinine or blood urea nitrogen > 2 times the Upper Normal Limit (UNL);
  • Urine sodium <20 mmol/day;
  • 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;
  • 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;
  • Use of systemic corticosteroids, methotrexate, cyclosporine, tacrolimus, sirolimus, octreotide, intravenous glutamine within the last 4 weeks;
  • Use of antibiotics within the last week or active infection;
  • 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;
  • Pregnant or lactating women;
  • History of psychiatric illnesses which lead to consider the patient as incapacitated and prevent him/her to provide informed consent;
  • 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;
  • Patient not capable of understanding or not willing to adhere to the study visit schedules and other protocol requirements;
  • 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;
  • Known hypersensitivity/allergy to ANY component of the IP.

Trial locations and contacts

8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Sabriye Duran contact

+49 089 89558070

sabriye.duran@alirahealth.com

Sara Papetti, MA contact

+39 3397978779

spapetti@napo.eu

8 sites in 2 countries

Germany5 sites, 5 recruiting

  • Universitäatsklinik RWTH

    Aachen, 52074

    Martin von Websky, MD

    Recruiting

  • Charité Universitätsmedizin

    Berlin, 10117

    Elisabeth Blüthner, MD

    Recruiting

  • Universitätsklinikum

    Essen, 45147

    Christoph Schramm, MD

    Recruiting

  • Asklepios Klinik St. Georg

    Hamburg, 20099

    Ulrich-Frank Pape, MD

    Recruiting

  • Universitätsmedizin

    Rostock, 18057

    Georg Lamprecht, MD

    Recruiting

Other trials in Germany

Italy3 sites, 3 recruiting

  • Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi

    Bologna, 40138

    Anna Simona Sasdelli, MD

    Recruiting

  • Azienda Ospedaliera Universitaria Federico II

    Naples, 80131

    Fabrizio Pasanisi, MD

    Recruiting

  • Ospedale Università di Padova

    Padova, 35128

    Edoardo Savarino, MD

    Recruiting

Other trials in Italy

About this study

Official title: A Phase 2, Placebo-Controlled, Randomized, Double-Blind Study of 2 Doses of Crofelemer for the Treatment of Adult Patients With Short Bowel Syndrome and Intestinal Failure (SBS-IF) Without Colon-in-continuity (CIC)

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.

Read the detailed description

This is 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).

After an up to 4-week screening period and a PS stabilization period that will last from 2 to 12 weeks, eligible patients who have meet the stabilization requirements will be randomized 1:1:1 to the following treatment groups and entered into the 24-week double-blind treatment period:

  • Crofelemer 3 mg/kg/dose TID, morning, midday and evening;
  • Crofelemer 10 mg/kg/dose TID, morning, midday and evening;
  • Matched placebo TID, morning, midday and evening.

Visits during the 24-week treatment period will be performed at baseline (Day 0) and after 1, 2, 4, 8, 12, 16, 20 and 24 weeks of treatments.

At the end of the 24-week treatment period, patients will be followed up for 4 weeks for safety.

For the primary and secondary objectives, changes between the two crofelemer and placebo arms will be assessed over the 24-week treatment period versus baseline.

Being tested
Crofelemer Powder for Oral Solution, Matched Placebo Powder for Oral Solution
Keywords
Short Bowel Syndrome
Medical subject headings
Short Bowel Syndrome, Malabsorption Syndromes, Postoperative Complications, Gastrointestinal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Crofelemer Powder for Oral SolutionDrug

    Crofelemer Powder for Oral Solution

  • Matched Placebo Powder for Oral SolutionDrug

    Matched Placebo Powder for Oral Solution

Study groups in NCT06904872
Study groupRoleWhat they receive
Crofelemer 3 mg/kg/dose three times daily (TID)ExperimentalParticipants randomized to the Crofelemer 3 mg/kg/dose arm will receive Crofelemer 3 mg/kg/dose by oral route three times per day (TID) morning, midday, and evening for 24 weeks.
Receives: Drug: Crofelemer Powder for Oral Solution
Crofelemer 10 mg/kg/dose three times daily (TID)ExperimentalParticipants randomized to the Crofelemer 10 mg/kg/dose arm will receive Crofelemer 10 mg/kg/dose by oral route three times per day (TID) morning, midday, and evening for 24 weeks.
Receives: Drug: Crofelemer Powder for Oral Solution
Matched Placebo three times per day (TID)Placebo comparatorParticipants randomized to the matched placebo arm will receive matched placebo by oral route three times per day (TID) morning, midday, and evening for 24 weeks.
Receives: Drug: Matched Placebo Powder for Oral Solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and Tolerability

    Frequency of Treatment-Emergent-Adverse Events

    Measured: 24 weeks

  2. Safety and Tolerability

    Frequency of IP interruption and/or discontinuation considered related to the study drug

    Measured: 24 weeks

  3. Preliminary Efficacy

    Change in weekly volume of parenteral support (PS: parenteral nutrition (PN) with or without intravenous (IV) fluid volume) from baseline, by recording PS volume in the patient daily diary

    Measured: 24 weeks

  4. Preliminary Efficacy

    Change in weekly stool volume from baseline, by measuring and recording daily stool volume in the patient daily diary

    Measured: 24 weeks

Secondary outcomes (10)

  1. Change in parenteral support volume

    Change from baseline in weekly PS volume at different study timepoints, as recorded in the patient daily diary

    Measured: 24 weeks

  2. Change in parenteral support calories intake

    Change in total number of calories administered, as detailed on the PS prescription written by the study doctor

    Measured: 24 weeks

  3. Change in parenteral support electrolytes intake

    Change in total number of electrolytes administered, as detailed on the PS prescription written by the study doctor

    Measured: 24 weeks

  4. Change in weekly oral fluid volume intake

    Change from baseline in weekly oral fluid volume intake, as recorded in the patient daily diary

    Measured: 24 weeks

  5. Number of days/week of PS

    Change in number of days/week of PS requirements from baseline

    Measured: 24 weeks

  6. Proportion of patients with change in number of days/week of PS

    Proportion of patients with at least one day reduction in weekly PS

    Measured: 24 weeks

  7. Change in volume of loose/watery stool

    Change from baseline in weekly loose/watery stools as measured by the volume in the ostomy bag or other measuring devices and recorded in the patient daily diary

    Measured: 24 weeks

  8. Changes from baseline in stool consistency

    Recording stool consistency of each stool using the 7-point Bristol Stool Scale in the patient daily diary

    Measured: 24 weeks

  9. Changes in laboratory parameters

    Changes from baseline of individual lab values within a chemistry and metabolic panel analysis

    Measured: 24 weeks

  10. Changes in physical examination

    Changes from baseline in physical examination findings (such as head, ears, eyes, nose, mouth, skin, heart, lung, lymph nodes, gastrointestinal, skeletal, and neurological signs and symptoms)

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2025
  2. Study start29 May 2025
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Eligible patients who have met the stabilization criteria above will be randomized to one of the following treatment groups and entered into the 24-week double-blind treatment period: * Crofelemer 3 mg/kg/dose TID, morning, midday and evening; * Crofelemer 10 mg/kg/dose TID, morning, midday and evening; * Matched placebo TID, morning, midday and evening.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06904872
Sponsor's protocol ID
NP303-501
Other IDs
2024-511994-31-00
Acronym
CRO-SBS-IF
Status last verified
May 2026
First submitted
10 Mar 2025
Last updated
9 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Guillen B, Atherton NS. Short Bowel Syndrome. 2023 Jul 17. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK536935/

    PubMed 30725620

  • Guy MK, Teixeira A, Lalani AS et al. Effects of oral on neratinib-induced diarrhea in beagle dogs. Cancer Res 2020;80(16) Supplement (Abstract#580).

  • Wales PW, Christison-Lagay ER. Short bowel syndrome: epidemiology and etiology. Semin Pediatr Surg. 2010 Feb;19(1):3-9. doi: 10.1053/j.sempedsurg.2009.11.001.

    PubMed 20123268

  • Vanderhoof JA, Langnas AN. Short-bowel syndrome in children and adults. Gastroenterology. 1997 Nov;113(5):1767-78. doi: 10.1053/gast.1997.v113.pm9352883.

    PubMed 9352883

  • Tradtrantip L, Namkung W, Verkman AS. Crofelemer, an antisecretory antidiarrheal proanthocyanidin oligomer extracted from Croton lechleri, targets two distinct intestinal chloride channels. Mol Pharmacol. 2010 Jan;77(1):69-78. doi: 10.1124/mol.109.061051. Epub 2009 Oct 6.

    PubMed 19808995

  • Thompson JS. Short Bowel Syndrome and Malabsorption - Causes and Prevention. Viszeralmedizin. 2014 Jun;30(3):174-8. doi: 10.1159/000363276.

    PubMed 26288591

  • Terrin G, Scipione A, De Curtis M. Update in pathogenesis and prospective in treatment of necrotizing enterocolitis. Biomed Res Int. 2014;2014:543765. doi: 10.1155/2014/543765. Epub 2014 Jul 17.

    PubMed 25147804

  • Tappenden KA. Pathophysiology of short bowel syndrome: considerations of resected and residual anatomy. JPEN J Parenter Enteral Nutr. 2014 May;38(1 Suppl):14S-22S. doi: 10.1177/0148607113520005. Epub 2014 Feb 5.

    PubMed 24500909

  • Schalamon J, Mayr JM, Hollwarth ME. Mortality and economics in short bowel syndrome. Best Pract Res Clin Gastroenterol. 2003 Dec;17(6):931-42. doi: 10.1016/s1521-6918(03)00079-9.

    PubMed 14642858

  • Pironi L, Arends J, Bozzetti F, Cuerda C, Gillanders L, Jeppesen PB, Joly F, Kelly D, Lal S, Staun M, Szczepanek K, Van Gossum A, Wanten G, Schneider SM; Home Artificial Nutrition & Chronic Intestinal Failure Special Interest Group of ESPEN. ESPEN guidelines on chronic intestinal failure in adults. Clin Nutr. 2016 Apr;35(2):247-307. doi: 10.1016/j.clnu.2016.01.020. Epub 2016 Feb 8.

    PubMed 26944585

  • Parrish CR, DiBaise JK. Managing the Adult Patient With Short Bowel Syndrome. Gastroenterol Hepatol (N Y). 2017 Oct;13(10):600-608.

    PubMed 29230136

  • Nee J, Salley K, Ludwig AG, Sommers T, Ballou S, Takazawa E, Duehren S, Singh P, Iturrino J, Katon J, Lee HN, Rangan V, Lembo AJ. Randomized Clinical Trial: Crofelemer Treatment in Women With Diarrhea-Predominant Irritable Bowel Syndrome. Clin Transl Gastroenterol. 2019 Dec;10(12):e00110. doi: 10.14309/ctg.0000000000000110.

    PubMed 31800542

  • Mangel AW, Chaturvedi P. Evaluation of crofelemer in the treatment of diarrhea-predominant irritable bowel syndrome patients. Digestion. 2008;78(4):180-6. doi: 10.1159/000185719. Epub 2008 Dec 18.

    PubMed 19092244

  • Lochs H, Dejong C, Hammarqvist F, Hebuterne X, Leon-Sanz M, Schutz T, van Gemert W, van Gossum A, Valentini L; DGEM (German Society for Nutritional Medicine); Lubke H, Bischoff S, Engelmann N, Thul P; ESPEN (European Society for Parenteral and Enteral Nutrition). ESPEN Guidelines on Enteral Nutrition: Gastroenterology. Clin Nutr. 2006 Apr;25(2):260-74. doi: 10.1016/j.clnu.2006.01.007. Epub 2006 May 15.

    PubMed 16698129

  • Kumpf VJ. Pharmacologic management of diarrhea in patients with short bowel syndrome. JPEN J Parenter Enteral Nutr. 2014 May;38(1 Suppl):38S-44S. doi: 10.1177/0148607113520618. Epub 2014 Jan 24.

    PubMed 24463352

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Crofelemer Powder for Oral Solution in people with Short Bowel Syndrome and Malabsorption Syndromes, run by Napo Therapeutics, S.p.A. at 8 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Germany, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sabriye Duran (+49 089 89558070, sabriye.duran@alirahealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Tolerability (time frame: 24 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06904872, which also lists 28 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.

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