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Tests treatment safety and results for Short Bowel Syndrome
Official title Safety and Efficacy of Crofelemer in Adult Patients With Short Bowel Syndrome and Intestinal Failure (SBS-IF) Without Colon-in-continuity (CIC)
ClinicalTrials.gov ID: NCT06904872
What this study is testing
What is Crofelemer Powder for Oral Solution?
Crofelemer Powder for Oral Solution is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for short bowel syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
See the full eligibility criteria
- 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...
- Minimum remaining length of 60 cm of small bowel;
- 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...
- 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...
- 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.
- 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;
- 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...
- 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 treatment 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...
- Known hypersensitivity/allergy to ANY component of the IP.
The study team makes the final eligibility decision.
Where it's taking place
- Aachen, Germany
- Berlin, Germany
- Essen, Germany
- Hamburg, Germany
- Rostock, Germany
- Bologna, Italy
- Naples, Italy
- Padova, Italy
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aachen, Germany; Berlin, Germany; Essen, Germany; Hamburg, Germany; Rostock, Germany; Bologna, Italy and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.