Using fecal microbiota transplantation to maintain remission in Crohn's disease after stopping anti-TNF treatment
Fecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF Withdrawal
This study is testing if a stool transplant can help keep people with Crohn's disease in remission after they stop using a certain medication.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 74 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT04997733 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of fecal microbiota transplantation (FMT) as a maintenance treatment for patients with Crohn's disease who are in remission after withdrawing from anti-TNF therapy. The trial aims to restore a healthy gut microbiota in patients whose condition is characterized by an inappropriate immune response and altered gut microbiota. Participants will receive either FMT or a sham treatment to assess the clinical outcomes over a specified period. The study is designed to address the lack of specific recommendations for Crohn's disease patients in remission under anti-TNF agents.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with Crohn's disease in steroid-free clinical remission for at least six months while on anti-TNF treatment.
Not a fit: Patients currently experiencing a flare of Crohn's disease or those who do not meet the inclusion criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new maintenance treatment option for Crohn's disease patients, potentially improving their quality of life and reducing reliance on immunosuppressive therapies.
How similar studies have performed: While previous studies have explored fecal microbiota transplantation for other conditions, randomized controlled trials specifically for Crohn's disease are lacking, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria for patients : * Age ≥ 18 years and \< 75 years * Crohn's disease (according to the Lennard-Jones criteria) for at least 6 months * Patient in steroid-free clinical remission for at least 6 months under anti-TNF agent (no clinical evidence of flare nor change in Crohn's disease specific treatment (anti-TNF, immunosuppressive, …) within 6 months before inclusion) and CDAI \<150 the week before inclusion) and willing to withdraw anti-TNF treatment * Female of child-bearing age with an active contraception and this during at least the period of treatment (week 52) * Patient with health insurance * Informed Written consent Inclusion Criteria for healthy volunteer donor : * Age ≥ 18 years and \< 50 years * 17 kg/m² \< body mass index \< 30 kg/m² * Regular bowel movement defined as at least 1 stool every other day and maximum 2 stools per day * Subject with health insurance (AME excepted) * Informed written consent Exclusion Criteria for patients : * Crohn's Disease complication requiring surgical treatment * Contraindication to colonoscopy or anesthesia * Pregnancy or breastfeeding during the study (Cf. Addendum 4) * Diagnosis of Crohn's disease restricted to the upper gastrointestinal tract (oesophagus, stomach, duodenum, jejunum) * Patient with active perineal disease (defined as evidence of perineal abscess or active draining fistula or presence of seton or presence of perineal ulceration) * History of more than one small bowel resection or small intestine resection \> 1 meter * Current stoma (Ileostomy or a colostomy) or stoma in the last 6 months or any other intra-abdominal surgery within 3 months prior to inclusion * Participation in any other interventional study * Patient under legal protection Exclusion Criteria for healthy volunteer donor : \- For details, please see protocol
Where this trial is running
Paris
- Gastroenterology Department of Saint Antoine Hospital — Paris, France (Recruiting)
Study contacts
- Principal investigator: Harry SOKOL, PU-PH — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Harry SOKOL, PU-PH
- Email: harry.sokol@aphp.fr
- Phone: 01 49 28 31 62
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.