Study on Preventing Recurrent Pouchitis in Ulcerative Colitis Patients Using Fecal Microbiota Transplant and Sodium Chloride

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What is this study about?

This clinical trial is focused on studying a condition known as recurrent pouchitis, which can occur in patients who have undergone a surgical procedure called ileal pouch-anal anastomosis for ulcerative colitis. The study aims to explore the effectiveness of a treatment involving fecal microbiota transplantation (FMT) using fresh donor feces, which is a suspension administered through an endoscopic procedure. This treatment is being compared to a placebo to determine if it can help delay the recurrence of pouchitis.

Participants in the study will receive either the fecal microbiota transplant or a placebo. The study will monitor the time it takes for pouchitis to return after the treatment. The trial will also observe any side effects and changes in the composition of gut bacteria over time. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who receives the actual treatment or the placebo, ensuring unbiased results.

The goal of this research is to find out if fecal microbiota transplantation can effectively prevent the recurrence of pouchitis in patients with a history of this condition following surgery for ulcerative colitis. The study will follow participants for a period to assess the long-term effects and benefits of the treatment.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying that the patient is 18 years or older, has undergone ileal pouch anal anastomosis (IPAA) surgery at least six months prior, and has experienced recurrent pouchitis.

A Pouchitis Disease Activity Index (PDAI) score of less than 7 is required at screening to ensure remission status.

2 fecal microbiota transplantation

The patient receives a fecal microbiota transplant using fresh donor feces administered endoscopically. This procedure is intended to delay the recurrence of pouchitis.

A sham transplantation may be performed as part of the study’s control measures.

3 monitoring and follow-up

The patient is monitored for any clinical and endoscopic signs of relapse. The primary endpoint is the time between transplantation and relapse, defined by a PDAI score of 7 or higher.

Secondary endpoints include relapse at weeks 24 and 52, the need for additional treatments, and the occurrence of any adverse events over a 104-week period.

4 microbiota analysis

At 8 weeks post-transplantation, fecal samples are analyzed to assess microbiota engraftment. This involves comparing the microbiota composition before and after the transplant using advanced sequencing technology.

5 final evaluation

The study concludes with a final evaluation of the patient’s condition, including the assessment of any disability related to inflammatory bowel disease (IBD) at various intervals throughout the study.

Who Can Join the Study?

Must be a male or female who is at least 18 years old at the time of signing the informed consent form.
Must understand and voluntarily sign an informed consent form before any study-related assessments or procedures.
Must be willing and able to follow the study visit schedule and other study requirements.
Must have had surgery called ileal pouch anal anastomosis (IPAA) at least 6 months before the screening visit. This is a type of surgery for ulcerative colitis.
Must have a diagnosis of recurrent pouchitis, which means having at least 2 episodes in the last year or relapsing right after responding to antibiotic treatment. Antifungal medication is allowed until the day before transplantation.
Must be in remission, meaning the condition is under control, with a Pouchitis Disease Activity Index (PDAI) score of less than 7 at the screening. This index measures the severity of pouchitis.
Must be affiliated with a social security system or be a beneficiary of such a system.
If female and able to have children, must have a negative pregnancy test at screening and agree to use effective birth control methods.

Who Cannot Join the Study?

Patients who have not had surgery called IPAA (Ileal Pouch-Anal Anastomosis) for a condition known as ulcerative colitis.
Patients who do not have a condition called recurrent pouchitis, which is inflammation of the pouch created during the IPAA surgery.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Hopital Saint Antoine	Paris	France
CHU Gabriel-Montpied	Clermont Ferrand	France
Hopital Beaujon	Clichy	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire De Nice	Nice	France
Centre Medico Chirurgical Ambroise Pare Hartmann	Neuilly-Sur-Seine	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Huriez	Lille	France
Cvqwes Hfewqgagmrd Rpmvgrwx Dupdpnapiocepl	Angers	France
Cqau De Nsfzj	Vandoeuvre Les Nancy	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	12.03.2020

Trial locations

Investigated drugs:

Fecal Microbiota Transplantation (FMT) is a procedure where stool from a healthy donor is processed and then introduced into the intestinal tract of a patient. The goal is to restore a healthy balance of bacteria in the gut. In this trial, FMT is being studied to see if it can help prevent the recurrence of pouchitis, which is an inflammation of the pouch created during surgery for ulcerative colitis.

Ulcerative Colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon and rectum. It is characterized by continuous inflammation of the innermost lining of the large intestine, leading to symptoms such as abdominal pain, diarrhea, and rectal bleeding. Over time, the inflammation can cause ulcers to form on the colon’s lining. The disease often progresses with periods of exacerbation and remission. Complications can include severe bleeding, perforation of the colon, and increased risk of colon cancer. The exact cause is unknown, but it is believed to involve an immune system malfunction.

Pouchitis – Pouchitis is an inflammation of the ileal pouch, which is created during surgery for ulcerative colitis or familial adenomatous polyposis. This condition typically occurs in patients who have undergone ileal pouch-anal anastomosis (IPAA) surgery. Symptoms include increased stool frequency, abdominal pain, and sometimes fever. The inflammation can lead to discomfort and affect the function of the pouch. Pouchitis can be acute or chronic, with some patients experiencing recurrent episodes. The exact cause is not well understood, but it may involve bacterial imbalance or immune response.

Trial ID:

2024-517078-52-00

Protocol code:

RC17_0021

NCT ID:

NCT03524352

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Preventing Recurrent Pouchitis in Ulcerative Colitis Patients Using Fecal Microbiota Transplant and Sodium Chloride

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?