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Study on Oral and Enema Fecal Microbiota Transplantation for Children with Ulcerative Colitis

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 a condition called Ulcerative Colitis, which is a long-term disease that causes inflammation and sores in the digestive tract, specifically affecting the colon and rectum. The study is exploring a treatment known as Fecal Microbiota Transplantation (FMT), which involves transferring stool from a healthy donor to the patient. This trial will use two forms of FMT: one is a Double encapsulated oral transplant of fecal microbiota, which is taken by mouth, and the other is an Enema transplant of fecal microbiota, which is administered rectally. The active substance in both treatments is called Allogeneic fecal microbiota, pooled, also known by the code name MaaT 033.

The purpose of this study is to see if these treatments can help maintain the health of children with Ulcerative Colitis by increasing the diversity of their gut bacteria. Participants in the study will receive either the oral or enema form of the treatment. The study will last for about eight months, during which the participants' gut bacteria will be monitored to see if there is an increase in diversity, which is a sign of a successful treatment. The study will also look at how similar the participants' gut bacteria become to that of the healthy donor over time.

Throughout the study, the participants' health and quality of life will be closely observed. This includes checking for any side effects, changes in their condition, and overall well-being. The study aims to provide valuable information on the effectiveness and feasibility of using FMT as a treatment for children with Ulcerative Colitis. The results could help improve future treatment options for this condition.

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
Initial visit
Upon joining the study, the patient will attend an initial visit. During this visit, eligibility will be confirmed based on specific criteria, such as age and medical condition. The patient must be between 8 to 17 years old and have a diagnosis of ulcerative colitis for more than 3 months.
The patient will undergo a series of assessments, including a review of their current treatment for ulcerative colitis, which must be stable for more than 3 months. For girls of childbearing age, a pregnancy test will be conducted, and they must agree to use a reliable contraceptive method during the study.
Step 2
Treatment phase
The treatment phase involves the administration of fecal microbiota transplantation (FMT) using two methods: oral capsules and rectal enema. The oral method involves taking double encapsulated capsules containing frozen stool, while the rectal method involves a stool enema.
The patient will receive the oral capsules and/or enema as per the study protocol. The frequency and duration of administration will be explained during the treatment phase.
Step 3
Follow-up visits
The patient will attend follow-up visits at specified intervals to monitor the success of the FMT. The primary goal is to increase the richness of the patient's microbiota, which will be evaluated at 6 months using a measure called the Shannon index.
Secondary evaluations will occur at 12 months, assessing the similarity of the patient's microbiota to that of a healthy donor and other health markers. These visits will also include assessments of the patient's quality of life and any adverse events.
Step 4
Final assessment
At the end of the study period, a final assessment will be conducted. This will include a comprehensive evaluation of the patient's microbiota, ulcerative colitis activity, and overall health.
The study aims to determine the long-term feasibility and effectiveness of FMT in children with ulcerative colitis, with results contributing to future treatment approaches.

Who can join the trial?

9 criteria

Patient aged 8 to 17 years old
Has been diagnosed with Ulcerative Colitis (UC) for more than 3 months. UC is a condition that causes inflammation and sores in the colon.
Has moderate active UC, which means a PUCAI score greater than 35. PUCAI is a scoring system used to measure the severity of UC in children.
Responds to corticosteroid treatment, with a PUCAI score less than 10 at the time of joining the study
Current treatment for UC (such as 5-ASA, immunosuppressants, or biotherapies) has been stable for more than 3 months
Able to swallow test capsules
For girls who can have children: Must have a negative pregnancy test and agree to use a reliable method of birth control from the first visit until the end of the study
Has health insurance
Both parents or guardians must sign an informed written consent form

Who cannot join the trial?

10 criteria

Patients with any other serious health conditions that might interfere with the study.
Patients who have had a recent infection or are currently taking antibiotics.
Patients who have had a major surgery in the past 6 months.
Patients who are pregnant or breastfeeding.
Patients with a history of severe allergies, especially to medications.
Patients who are currently participating in another clinical trial.
Patients with a history of drug or alcohol abuse.
Patients who have a compromised immune system, meaning their body's defense against infections is weakened.
Patients who have been diagnosed with cancer in the past 5 years.
Patients who have a history of organ transplant.

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Assistance Publique Hopitaux De Paris
Verified
Paris, France

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Investigated drugs

Frozen Stool Capsules are used in this clinical trial as a form of fecal microbiota transplantation (FMT). This therapy involves taking capsules that contain stool from a healthy donor. The goal is to introduce beneficial bacteria into the gut of patients with pediatric Ulcerative Colitis. By doing this, the treatment aims to increase the diversity and richness of the gut microbiota, which can help in maintaining the health of the colon and potentially reduce symptoms of the disease.

Allogeneic Faecal Microbiota, Pooled

What is already known about the treatment

Frozen Stool Capsules – This medication is administered orally in the form of capsules and is used in a novel technique called Oral Fecal Transplantation. It is currently being studied in clinical trials for its effectiveness in maintaining treatment for pediatric Ulcerative Colitis. The main therapeutic indication is to increase the diversity of the gut microbiota, which is believed to help manage symptoms of Ulcerative Colitis. At the molecular level, the mechanism involves introducing beneficial bacteria into the gut to restore a healthy balance. This medication falls under the pharmacological classification of microbiota-based therapies.

Investigated diseases

Ulcerative Colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon, also known as the large intestine. It is characterized by inflammation and ulceration of the innermost lining of the colon, leading to symptoms such as abdominal pain, diarrhea, and rectal bleeding. The disease typically begins in the rectum and may extend continuously to involve the entire colon. The inflammation causes the colon to empty frequently, resulting in diarrhea. Over time, the inflammation can lead to the formation of ulcers, which are small open sores that can bleed and produce pus. The progression of ulcerative colitis can vary, with periods of active symptoms followed by times of remission.