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Study on the Safety and Effects of MBF-118 for Crohn's Disease Patients with Stenosis

Verified siteInvestigationalNo placebo

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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, leading to symptoms like abdominal pain, severe diarrhea, fatigue, weight loss, and malnutrition. The trial will test a new treatment called MBF-118, which is taken as hard capsules. The purpose of the study is to evaluate the safety and tolerability of MBF-118 in patients with Crohn's disease who have a narrowing in their intestines, known as stenosis.

Participants in the study will take MBF-118 for 28 days, and their health will be monitored until day 56. The study will look at how well the treatment is tolerated by checking for any side effects and changes in vital signs, physical exams, and lab tests. Additionally, the study will observe changes in the thickness of the bowel wall and other markers of inflammation in the body. This will help researchers understand how the treatment affects the body and its potential benefits for people with Crohn's disease.

Throughout the study, participants will have regular check-ups to monitor their progress and ensure their safety. The information gathered will help determine if MBF-118 is a safe and effective treatment option for managing Crohn's disease with stenosis. This research is important for developing new therapies that can improve the quality of life for individuals living with this challenging condition.

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
Beginning of the trial
Upon joining the study, you will receive a detailed explanation of the trial process. This includes understanding the purpose of the study, which is to assess the safety and tolerability of MBF-118 in patients with Crohn's disease.
You will be asked to provide written informed consent, confirming your understanding and willingness to participate in the trial.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes reviewing your medical history and current condition to ensure you meet the criteria for participation.
You will undergo tests to establish baseline measurements, such as bowel wall thickness and levels of certain proteins in your blood and stool.
Step 3
Medication administration
You will begin taking the study medication, MBF-118, in the form of hard capsules. The medication is taken orally.
The dosage and frequency will be explained to you, and you will take the medication for a period of 28 days.
Step 4
Monitoring and follow-up
Throughout the 28-day period, you will be monitored for any side effects or changes in your condition. This includes regular check-ups and tests to assess your health and the medication's effects.
After the 28-day medication period, there will be a follow-up phase lasting until day 56. During this time, additional assessments will be conducted to evaluate any lasting effects of the medication.
Step 5
End of trial
At the end of the trial, a final assessment will be conducted to gather comprehensive data on your health status and the impact of the medication.
You will receive information on the next steps and any further care or treatment options available to you.

Who can join the trial?

8 criteria

Must be a male or a nonpregnant, nonlactating female aged between 18 and 75 years.
Must have a diagnosis of Crohn's disease confirmed by clinical tests, endoscopy (a procedure to look inside the digestive tract), and histology (study of tissues) at least 3 months before joining the study.
Must have mild to severe ileocolonic Crohn's disease (affecting the end of the small intestine and the beginning of the large intestine).
Can have no more than 2 naïve or anastomotic small bowel strictures (narrowing of the small intestine) in the terminal ileum (last part of the small intestine) as seen in imaging tests. A stricture is defined as:
- Localized narrowing of the bowel (50% or less of normal width).
- Thickening of the bowel wall (25% thicker than normal).
- Length of the stricture is less than 12 cm.
- If using a treatment for Crohn's disease, must be on a stable dose for at least 3 months before the study starts. Acceptable treatments include non-steroidal anti-inflammatory drugs (NSAIDs) and anti-inflammatory biologics (medications that reduce inflammation).
- Must be able to fully participate in all parts of the clinical trial and understand the consent form, which must be signed and documented.

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.
Patients who are part of a vulnerable population may not be eligible.

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Verified
Universidade De Santiago De Compostela
Santiago De Compostela, Spain

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Investigated drugs

MBF-118 is a medication being studied for its potential to help people with Crohn's disease, specifically those who have a narrowing in their intestines, known as stenosis. This medication is being tested to see if it can reduce the formation of scar tissue, which can cause these narrowings. The trial aims to understand how safe and tolerable MBF-118 is when used alongside the usual treatments for Crohn's disease. Participants in the study will take MBF-118 for 28 days, and researchers will continue to monitor them for any effects until day 56. The goal is to see if MBF-118 can help improve the condition without causing significant side effects.

Mbf-118

What is already known about the treatment

MBF-118 – MBF-118 is administered orally and is currently being studied in clinical trials for its potential use in treating Crohn's disease, specifically in patients with stenosis. This medication is in the early stages of research, and its safety and effectiveness are being evaluated. MBF-118 is believed to work by reducing fibrosis, which is the thickening and scarring of tissue, through its action at the molecular level, although the exact mechanism is still under investigation. It falls under the pharmacological classification of antifibrotic agents, which are drugs designed to prevent or reduce tissue scarring.

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 periods of active disease, known as flare-ups, and periods of remission. During flare-ups, individuals may experience symptoms such as abdominal pain, diarrhea, fatigue, and weight loss. The inflammation can lead to complications like bowel obstruction, fistulas, and malnutrition. The disease progresses with alternating cycles of symptom exacerbation and relief, and the severity can vary widely among individuals. Over time, the inflammation can cause damage to the intestinal walls, leading to further complications.