Study on Crofelemer for Adults with Short Bowel Syndrome and Intestinal Failure Without Colon in Continuity

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What is this study about?

This clinical trial is focused on studying a condition known as Short Bowel Syndrome with Intestinal Failure (SBS-IF), specifically in patients who do not have a continuous colon. This condition occurs when a significant portion of the small intestine is missing or not functioning properly, leading to difficulties in absorbing nutrients and fluids. The study will test a treatment called Crofelemer, which is provided as a powder for oral solution. Crofelemer is being investigated to see if it can help manage symptoms and improve the quality of life for those affected by SBS-IF.

The purpose of the study is to assess the safety and initial effectiveness of Crofelemer in adults with SBS-IF. Participants will be randomly assigned to receive either Crofelemer or a placebo, which is a substance with no active medication. The study will be conducted in a double-blind manner, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This approach helps ensure that the results are unbiased. The study will last for 24 weeks, during which participants will take the medication and attend regular check-ups to monitor their health and any changes in their condition.

Throughout the study, researchers will closely observe the frequency of any side effects and how the treatment affects the participants’ need for parenteral support, which is the intravenous delivery of nutrients and fluids. The study aims to determine if Crofelemer can reduce the volume of parenteral support needed and improve stool consistency. Participants will also be monitored for any changes in their overall health, including liver and kidney function, as well as glucose and lipid levels. This trial is an important step in exploring new treatment options for those living with SBS-IF.

1 joining the study

Upon joining the study, the patient will be randomly assigned to receive either crofelemer or a placebo. The study is double-blind, meaning neither the patient nor the researchers will know which treatment the patient is receiving.

The patient must provide written informed consent, confirming understanding of the study procedures and willingness to complete the required assessments.

2 treatment administration

The patient will take the assigned treatment orally. The treatment is in the form of a powder for oral solution.

The study involves two different doses of crofelemer, but specific dosage details are not provided in the available information.

3 treatment period

The treatment period lasts for 24 weeks. During this time, the patient will continue to take the assigned treatment as directed.

The patient will be monitored for any treatment-emergent adverse events and any interruptions or discontinuations of the investigational product.

4 monitoring and assessments

Throughout the 24-week treatment period, the patient will undergo regular assessments to monitor the effects of the treatment.

These assessments include measuring changes in the volume of parenteral support, stool volume, and stool consistency. Safety laboratory parameters, such as liver and renal function, glucose, and lipids, will also be checked at specified intervals.

5 end of treatment

At the end of the 24-week treatment period, the patient will complete final assessments to evaluate the overall effects of the treatment.

The study aims to assess the safety and tolerability of crofelemer and its preliminary efficacy in reducing the need for parenteral support and improving stool consistency.

Who Can Join the Study?

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.
Patients must be receiving parenteral support (fluids, electrolytes, and/or nutrients) for at least three days per week and a minimum of 2 liters per week to meet caloric, fluid, or electrolyte needs. Parenteral support means getting nutrients directly into the bloodstream through an IV.
Patients with Crohn’s disease must be in clinical remission for at least 12 weeks. Clinical remission means that the symptoms of the disease are not currently active.
Patients must be able to eat solid or semi-solid foods and drink fluids.
If patients are taking certain medications like antimotility and antidiarrheal agents, H2-receptor antagonists, proton pump inhibitors, bile sequestering agents, oral glutamine, diuretics, and oral rehydration solutions, they must be on stable doses for at least 4 weeks before the study starts.
If female and capable of becoming pregnant, the patient must use an “acceptable effective contraceptive measure” during the study and for 4 weeks after the last dose. Acceptable methods include certain hormonal contraceptives, condoms, and other barrier methods. Male patients must agree to use an acceptable form of birth control and not donate sperm during the study and for 4 weeks after the last dose.
If female and capable of becoming pregnant, the patient must have a negative urine pregnancy test before the first administration of the study medication.
Patients must have a satisfactory general health status as determined by the investigator based on current clinical status, medical history, and physical examination.
Male and female patients must be aged 18 years or older.
Patients with Short Bowel Syndrome (SBS) with intestinal failure and without colon-in-continuity, who are not eligible or not willing to receive an approved marketed GLP-2.
Patients must have a 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. This means they have had a significant part of their intestine removed, leading to the need for IV supplementation to maintain health.
Patients must have a minimum estimated remaining length of 100 cm of small bowel.
At least 6 months must have passed since the last surgical bowel resection.
No restorative surgery should be planned during the entire study period.
Patients must have at least 4 continuous months of dependency on parenteral support (parenteral nutrition with or without intravenous fluids).
Patients must have chronic non-infectious diarrhea, defined as having at least 1 loose watery stool per day for more than 4 consecutive weeks.

Who Cannot Join the Study?

Patients who have a condition called Short Bowel Syndrome with Intestinal Failure but have a part of their colon still connected cannot participate.
Patients who are not adults cannot participate. This means only people who are 18 years or older can join.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy

Other Sites

Site Name	City	Country
Universitaetsklinikum Aachen AöR	Aachen	Germany
Asklepios Klinik St George	Hamburg	Germany
Azienda Ospedaliera di Padova	Padua	Italy
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Upmgyptfodybbnbzegkrp Eoesl Ald	Essen	Germany
Zwmdqei Flvp Izcfkn Myoqtux	Rostock	Germany
Abpkzdn Uxfbj Sghsbywfo Lkxcdg Da Bofbswn	Bologna	Italy

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	15.11.2024
Italy	Recruiting	15.11.2024

Trial locations

Investigated drugs:

Crofelemer

Crofelemer is being studied for its potential to help adult patients with Short Bowel Syndrome and Intestinal Failure (SBS-IF) who do not have a colon in continuity. The trial aims to assess how safe and tolerable this medication is for patients, as well as to evaluate its preliminary effectiveness in managing the condition. Crofelemer works by regulating fluid secretion in the intestines, which may help reduce symptoms associated with SBS-IF.

Investigated diseases:

Short-bowel syndrome

Short Bowel Syndrome with Intestinal Failure (SBS-IF) without Colon-in-Continuity (CIC) – This condition occurs when a significant portion of the small intestine is missing or not functioning properly, leading to malabsorption of nutrients and fluids. It often results from surgical removal of parts of the intestine due to disease or injury. Patients with this syndrome may experience severe diarrhea, dehydration, and malnutrition due to the reduced ability to absorb nutrients. The absence of the colon-in-continuity means that the colon is not connected in a way that aids in fluid and electrolyte absorption. Over time, individuals may require parenteral nutrition, which involves receiving nutrients directly into the bloodstream. The condition can significantly impact daily life, requiring careful management of diet and fluid intake.

Trial ID:

2024-511994-31-00

Protocol code:

NP303-501

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Crofelemer for Adults with Short Bowel Syndrome and Intestinal Failure Without Colon in Continuity

What is this study about?

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