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Study on Using Ultrasound with Perflubutane and Laxative for Detecting Crohn's Disease in Patients

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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 Crohn's disease, a condition that causes inflammation in the digestive tract, particularly affecting the small bowel. The study aims to develop a new method for examining the small bowel using a special type of ultrasound called transabdominal ultrasound. This method uses tiny bubbles, known as microbubbles, as a contrast to help doctors see the inside of the bowel more clearly.

Two treatments are being used in this study. The first is a product called Laxabon, which is a type of laxative that helps clear the bowel. It contains several substances, including sodium hydrogen carbonate, potassium chloride, sodium chloride, sodium sulfate anhydrous, and macrogol 3350. The second treatment is called Sonazoid, which is a dispersion for injection containing perflubutane. This is used to enhance the ultrasound images by providing a clearer view of the bowel's interior.

The purpose of the study is to see how well these treatments work in providing a clear image of the bowel and to check for any side effects. Participants will undergo a procedure where they ingest the contrast, and doctors will use ultrasound to examine the bowel. The study will also look at how many participants are willing to undergo the procedure again and will compare findings between patients with Crohn's disease and healthy volunteers. The study is expected to continue until the end of 2028.

The research process

The trial runs in 5 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 asked to provide signed informed consent. This means you agree to follow the study's requirements and restrictions.
Step 2
Preparation for the procedure
You will be given a medication called Laxabon, which is an oral solution. This solution contains several substances, including sodium hydrogen carbonate, potassium chloride, sodium chloride, sodium sulfate anhydrous, and macrogol 3350.
You will need to take this solution by mouth as instructed by the study team. The purpose of this solution is to prepare your bowel for the procedure.
Step 3
Undergoing the procedure
During the procedure, a method called transabdominal ultrasound will be used. This involves using sound waves to create images of your small bowel.
A special contrast agent called Sonazoid will be used. This is a dispersion for injection that contains perflubutane. It helps to improve the visibility of your bowel during the ultrasound.
Step 4
Monitoring and assessment
After the procedure, you will be monitored for any side effects or adverse events. The study team will assess the images obtained during the ultrasound to check for any abnormalities in your bowel.
The primary goal is to see if the contrast fills the entire bowel and to separate the bowel wall from the inside of the bowel.
Step 5
Follow-up
You may be asked about your willingness to undergo the procedure again in the future.
The study team will also evaluate the presence of any bowel conditions, such as ulcers or narrowing, and compare these findings with other tests like endoscopy.

Who can join the trial?

4 criteria

Patients must be over 18 years old.
Patients must have Crohn's disease in a specific part of the intestine called the terminal ileum and must undergo a procedure called ileocolonoscopy (a test to look inside the intestines).
Healthy volunteers over 18 years old without any known stomach or intestinal illnesses can also participate.
Participants must be able to give signed informed consent, which means they understand the study and agree to follow the rules and requirements.

Who cannot join the trial?

3 criteria

Patients who do not have Crohn's disease cannot participate.
Patients who are not within the specified age range cannot participate. The age range includes young adults and adults.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups like children, pregnant women, or those unable to give consent.

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Helse Bergen HF
Bergen, Norway

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Investigated drugs

Microbubbles are tiny gas-filled bubbles that are used in this clinical trial as a contrast agent. When introduced into the body, they help improve the clarity of ultrasound images. In this study, microbubbles are used to enhance the visibility of the small bowel during an ultrasound examination. This helps doctors better detect and assess Crohn's disease, a condition that affects the digestive tract. By using microbubbles, the ultrasound can provide more detailed images, making it easier to identify any abnormalities or changes in the bowel.

What is already known about the treatment

Sonographic Diagnostics with Oral Contrast – This innovative method involves using a special oral contrast agent, known as microbubbles, to enhance ultrasound imaging for detecting Crohn's disease in the small bowel. Currently, this technique is being explored in clinical trials and is not yet a standard practice in medical literature. The primary therapeutic indication is for diagnosing Crohn's disease, a chronic inflammatory condition of the digestive tract. The microbubbles work by improving the visibility of the bowel during an ultrasound, allowing for better detection of abnormalities. This method falls under the category of diagnostic imaging techniques rather than traditional pharmacological classifications.

Investigated diseases

Crohn's disease – Crohn's disease is a chronic inflammatory condition of the gastrointestinal tract, primarily affecting the small intestine and colon. It is characterized by inflammation that can penetrate deep into the layers of the bowel tissue, leading to symptoms such as abdominal pain, diarrhea, and weight loss. The disease often progresses with periods of remission and flare-ups, where symptoms become more severe. Over time, the inflammation can cause complications such as strictures, which are narrowings of the intestine, and fistulas, which are abnormal connections between different parts of the intestine or other organs. The inflammation can also lead to the formation of ulcers, which are open sores in the lining of the intestine. Crohn's disease can affect any part of the gastrointestinal tract from the mouth to the anus, but it most commonly affects the end of the small intestine and the beginning of the colon.