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Study on How Apixaban and Teduglutide Affect Patients with Short Bowel Syndrome on Long-Term Parenteral Nutrition

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of the medication Apixaban in patients with Short Bowel Syndrome, a condition where a significant portion of the small intestine is missing or has been surgically removed, leading to difficulties in absorbing nutrients. The study also involves the medication Teduglutide, which is used to help improve nutrient absorption in these patients. The purpose of the study is to investigate how the body processes Apixaban in patients with and without Short Bowel Syndrome who require long-term nutritional support through intravenous feeding.

Participants in the study will be divided into different groups. Some groups will include patients with Short Bowel Syndrome who have not previously taken Apixaban or Teduglutide, while others will include patients who are already on these medications. There will also be a group of healthy volunteers without any history of gastrointestinal issues. The study will compare the levels of Apixaban in the blood after taking different doses of the medication, to see if there are differences between those with and without Short Bowel Syndrome.

The study will take place over a period of time, with participants receiving either Apixaban or a placebo. The goal is to better understand how Apixaban is absorbed and processed in the body, which could help improve treatment options for patients with Short Bowel Syndrome who need long-term nutritional support.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be assigned to one of several groups based on your medical history and current treatment. This assignment is crucial for the study's objectives.
Step 2
Medication administration
If you are in the group receiving apixaban, you will take either 2.5 mg or 5 mg of the medication twice daily. This medication is taken orally, meaning you will swallow it.
If you are in the group receiving teduglutide, this medication will be administered subcutaneously, which means it is injected under the skin. The frequency and dosage will be determined by the study team.
Step 3
Monitoring and assessments
Throughout the study, regular monitoring will occur to assess how your body processes the medication. This may involve blood tests and other assessments to measure the concentration of the medication in your system.
These assessments are designed to understand the peak concentration levels of apixaban in your body.
Step 4
Completion of the study
The study is expected to continue until the end of 2024. Upon completion, you will receive information about the study's findings and any relevant health information.

Who can join the trial?

8 criteria

Patients with short bowel syndrome (SBS), which means having a small bowel length of less than 2 meters after the Treitz ligament.
Must be on long-term (more than 3 months) parenteral nutrition or fluids. Parenteral nutrition is a way of getting nutrition into the body through the veins.
For some groups, patients must not have taken apixaban, vitamin K antagonists, or teduglutide before. Apixaban is a medication that helps prevent blood clots, vitamin K antagonists are a type of blood thinner, and teduglutide is a medication used to treat SBS.
For other groups, patients must already be taking apixaban 2.5 mg or 5 mg twice daily for at least 4 days.
Healthy individuals without a history of gastrointestinal surgeries or conditions that affect absorption can participate as controls.
Participants must sign an informed consent form, which means they agree to take part in the study after understanding all the details.
Both male and female participants are eligible.
Participants should not be part of a vulnerable population, meaning they should not be in a group that needs special protection in research.

Who cannot join the trial?

2 criteria

Patients who do not have short bowel syndrome cannot participate. Short bowel syndrome is a condition where part of the small intestine is missing or not working properly.
Patients who do not require long-term parenteral nutrition cannot participate. Parenteral nutrition is a way of getting nutrition into the body through the veins, bypassing the usual process of eating and digestion.

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Katholieke Universiteit te Leuven
Leuven, Belgium

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Investigated drugs

Apixaban is a medication used to prevent blood clots. It works by blocking certain proteins in your blood that are involved in the clotting process. In this clinical trial, researchers are studying how the body absorbs and processes apixaban in patients who have a condition called short bowel syndrome and need long-term nutrition through a vein. The goal is to see if these patients have different levels of the medication in their blood compared to those without the condition. This information can help doctors understand how to better use apixaban in patients with short bowel syndrome.

What is already known about the treatment

Apixaban – Apixaban is a medication taken orally, usually in the form of a tablet, and is used to prevent blood clots. It is currently well-established in medical practice and literature, particularly for patients with conditions that increase the risk of clotting. In this clinical trial, it is being studied for its effects in patients with short bowel syndrome who require long-term parenteral nutrition. Apixaban works by inhibiting a specific protein in the blood called Factor Xa, which plays a crucial role in the formation of blood clots. It is classified as an anticoagulant, which means it helps to prevent the formation of harmful clots in the blood vessels.

Investigated diseases

Short Bowel Syndrome – Short Bowel Syndrome is a condition that occurs when a significant portion of the small intestine is missing or has been surgically removed. This leads to a reduced ability to absorb nutrients and fluids from food. As a result, individuals may experience symptoms such as diarrhea, malnutrition, and dehydration. The condition can vary in severity depending on the length and function of the remaining intestine. Over time, the body may adapt to the changes, but nutritional deficiencies can persist. Management often involves dietary adjustments and nutritional support to ensure adequate intake of essential nutrients.