Ongoing Clinical Trials for Enteritis
Currently, there is 1 ongoing clinical trial investigating treatments for enteritis-related conditions. This trial is taking place in France and focuses on preventing recurrent pouchitis in patients who have undergone surgery for ulcerative colitis, using fecal microbiota transplantation.
Clinical trial locations
Study on Preventing Recurrent Pouchitis in Ulcerative Colitis Patients Using Fecal Microbiota Transplant and Sodium Chloride
This trial is investigating whether fecal microbiota transplantation can help prevent the return of pouchitis in patients who have had surgery for ulcerative colitis. Pouchitis is an inflammation that can develop in the pouch created during a specific type of surgery called ileal pouch-anal anastomosis.
Who can participate:
- Adults aged 18 years or older
- Patients who have undergone ileal pouch-anal anastomosis surgery at least 6 months before joining the study
- Those with a diagnosis of recurrent pouchitis, meaning they have had at least 2 episodes in the past year or experience symptoms returning right after antibiotic treatment
- Patients currently in remission, with a Pouchitis Disease Activity Index score of less than 7
- Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control
- Participants must be affiliated with a social security system
Who cannot participate:
- Patients who have not had ileal pouch-anal anastomosis surgery for ulcerative colitis
- Those without recurrent pouchitis
- Individuals outside the specified age range
- People considered vulnerable populations who may require special protection
What the trial involves:
The main goal of this research is to determine whether fecal microbiota transplantation can effectively delay the recurrence of pouchitis. Participants will receive either the active treatment or a placebo through an endoscopic procedure. The study is designed as a double-blind trial, meaning neither the participants nor the researchers will know who receives which treatment until the study ends.
The treatment being tested involves using fresh donor stool that has been processed and prepared for transplantation. This approach aims to restore a healthy balance of bacteria in the gut, which may help reduce inflammation and prevent pouchitis from returning.
Participants will be monitored over an extended period to track when or if pouchitis returns. The study will also examine changes in gut bacteria composition at 8 weeks after the transplant, assess any side effects, and evaluate the need for additional treatments. Follow-up assessments will continue for up to 104 weeks to measure the long-term effects of the treatment.
Investigational treatment:
Fecal Microbiota Transplantation is the primary treatment being studied. This procedure involves transferring processed stool from a healthy donor into the patient’s intestinal tract. The goal is to re-establish a healthy bacterial environment in the gut, which may help prevent inflammation and reduce the risk of pouchitis recurrence.
Summary
Currently, only one clinical trial is available for enteritis-related conditions, specifically focusing on recurrent pouchitis in ulcerative colitis patients. This trial is being conducted in France and represents an innovative approach using fecal microbiota transplantation to prevent disease recurrence. The study reflects growing interest in microbiome-based therapies for inflammatory bowel conditions. Patients with recurrent pouchitis who have undergone ileal pouch-anal anastomosis surgery may wish to discuss this trial opportunity with their healthcare providers to determine if participation might be appropriate for their situation.