Study on INTESTIFIX for Maintaining Remission in Children and Adults with Crohn’s Disease After Exclusive Enteral Nutrition Treatment

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What is this study about?

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 study will use a treatment called INTESTIFIX 001, which involves capsules containing a mixture of bacterial cells and other components from human fecal microbiota. This treatment is known as fecal microbiota transfer (FMT). The trial will also use INTESTIFIX 001 Placebo capsules, which do not contain the active treatment.

The purpose of the study is to assess the safety, feasibility, and effectiveness of the multi-donor FMT treatment in maintaining remission, which means keeping the disease under control, after an initial treatment with a special diet called Exclusive Enteral Nutrition (EEN). The study will include both children and adults with Crohn’s disease. Participants will take the capsules orally, and the study will monitor their health and symptoms over a period of time to see how well the treatment works compared to the placebo.

Throughout the study, participants will have regular check-ups to monitor their condition and any side effects. The trial will last several months, and researchers will collect information on how the treatment affects the participants’ symptoms and overall health. The goal is to determine if the FMT treatment can help maintain remission in people with Crohn’s disease after they have completed the initial dietary treatment.

1 initial visit and consent

Upon joining the study, you will attend an initial visit where you will be asked to provide a signed and dated, written informed consent form. If you are a child, both parents or legal guardians must provide consent, and you will also need to give your assent.

During this visit, you will undergo tests to ensure you meet the study’s eligibility criteria, including stool tests to check for any infections.

2 screening and preparation

You will be screened for eligibility, which includes confirming a diagnosis of Crohn’s disease and ensuring you have mild to moderate disease activity.

If you are a woman of childbearing potential, you must use effective birth control methods throughout the study. Men must use condoms, and their female partners should also use contraception if they are of childbearing potential.

3 treatment phase

The treatment phase involves taking INTESTIFIX 001 capsules or placebo orally. The dosage and frequency will be determined by the study protocol.

This phase aims to maintain remission of Crohn’s disease after initial treatment with exclusive enteral nutrition (EEN).

4 regular follow-up visits

You will attend regular follow-up visits at weeks 0, 4, 8, 12, 16, 24, and 32. During these visits, your health and response to the treatment will be monitored.

These visits will include assessments such as blood tests, stool samples, and possibly intestinal ultrasounds to evaluate your condition.

5 end of study

At the end of the study, your overall health and the effectiveness of the treatment will be evaluated.

You will be asked to provide feedback on your experience and any changes in your quality of life during the study.

Who Can Join the Study?

Sign a written consent form before any study procedures. For children, both parents or legal guardians must sign, and the child must agree verbally or in writing.
Have a negative stool test for harmful bacteria. This includes a stool culture and a test for Clostridioides difficile (a type of bacteria that can cause diarrhea).
Women who can have children and are sexually active must use effective birth control methods, including a combination of hormonal and barrier methods (like condoms). Women who cannot have children due to surgery or menopause do not need to follow this rule.
Men who can father children must use condoms. If their female partner can have children, she should also use hormonal or barrier birth control methods.
Participants or their guardians must understand the study and be able to follow instructions, including providing stool samples and attending all visits.
Be between 8 and 45 years old and weigh at least 20 kg (about 44 pounds).
Have a confirmed diagnosis of Crohn’s disease affecting the small intestine, colon, or both, confirmed by a doctor using a camera test (endoscopy) and tissue samples (histology).
Be able to swallow the study medication or placebo.
Have mild to moderate disease activity, measured by specific scores or have milder disease with high levels of a protein called calprotectin in stool.
Show improvement after a special diet treatment called Exclusive Enteral Nutrition (EEN).
Be on no treatment or stable doses of certain medications for Crohn’s disease, such as:
- Oral 5-aminosalicylic acid (5-ASA) for at least 4 weeks.
- Methotrexate (MTX) for at least 4 weeks.
- 6-mercaptopurine (6-MP) or azathioprine (AZA) for at least 12 weeks.
- Biologic drugs (e.g., TNF antagonists, vedolizumab) for at least 16 weeks.
- JAK inhibitors (e.g., Upadacitinib) for at least 16 weeks.
- Not using steroids for at least 2 weeks.
Achieve remission (no symptoms) without using steroids after at least 6 weeks of EEN.

Who Cannot Join the Study?

Patients who have a history of severe allergic reactions to any component of the study treatment.
Individuals with a current or recent infection that requires treatment with antibiotics.
Patients who have had a major surgery within the last 3 months.
Individuals with a history of cancer, except for certain types of skin cancer that have been treated.
Patients who are pregnant or breastfeeding.
Individuals with a history of substance abuse or alcohol dependency.
Patients who are currently participating in another clinical trial.
Individuals with a known history of HIV, hepatitis B, or hepatitis C.
Patients with any other medical condition that the study doctors believe would make participation unsafe.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
University Hospital Jena KöR	Jena	Germany

Other Sites

Site Name	City	Country
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Deutsches Herzzentrum Berlin	Berlin	Germany
Lcqkfw Memkermbfn Uzxmaliuyu Oe Mivktl	Munich	Germany
Knkftozt dzs Utgbanwynfze Mvlnymxy Agg	Munich	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	01.07.2023

Trial locations

Investigated drugs:

Intestifix

INTESTIFIX 001 FMT capsules are a type of treatment that involves transferring healthy bacteria from the stool of multiple donors into the gut of a person with Crohn’s disease. This process is known as fecal microbiota transfer (FMT). The goal of using these capsules is to help maintain remission, which means keeping the disease under control after it has been improved by another treatment called Exclusive Enteral Nutrition (EEN). The capsules are taken orally and are designed to restore a healthy balance of bacteria in the intestines, which may help reduce symptoms and prevent flare-ups of Crohn’s disease.

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 affect different layers of the bowel wall and may lead to complications like strictures or fistulas. The exact cause of Crohn’s disease is unknown, but it involves an abnormal immune response to intestinal bacteria. The disease can vary greatly in severity and progression among individuals.

Trial ID:

2022-503027-10-00

Protocol code:

IBD-EEN-RICH_01

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on INTESTIFIX for Maintaining Remission in Children and Adults with Crohn’s Disease After Exclusive Enteral Nutrition Treatment

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