Adult patients with ulcerative colitis diagnosed for at least 3 months
Conditions
Brief summary
Steroid-free clinical and endoscopic remission at week 12 is defined as a total Mayo score of 2 or lower and no subscore higher than 1 and mucosal healing defined as an endoscopic subscore of 0 or 1 (sigmoidoscopy).
Detailed description
Steroid-free clinical remission is defined as a Partial Mayo Clinic score of 0 or 1, Steroid-free endoscopic response is defined as a Mayo endoscopy subscore of 1 or less, with a reduction of at least 1 point from baseline, Steroid-free clinical remission is defined as a Partial Mayo Clinic score of 0 or 1, Steroid-free endoscopic remission is defined as Endoscopic Mayo Clinic subscore of 0., Microbiota composition and diversity assessed by 16s sequencing at week 12 and 24, compared to baseline and to healthy volunteers donor’s microbiota., Proportion of adverse events in each group (Abdominal pain, Nausea, vomiting, fever, modified intestinal transit, an episode of infection), Inflammatory biological parameter: CRP, fecal calprotectin, platelet number, Endoscopic lesions at coloscopy and sigmoidoscopy (week 12) by endoscopic Mayo score and UCEIS score
Interventions
DRUGPlacebo Enema transplant of fecal microbiota
Sponsors
Assistance Publique Hopitaux De Paris
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Steroid-free clinical and endoscopic remission at week 12 is defined as a total Mayo score of 2 or lower and no subscore higher than 1 and mucosal healing defined as an endoscopic subscore of 0 or 1 (sigmoidoscopy). | — |
Secondary
| Measure | Time frame |
|---|---|
| Steroid-free clinical remission is defined as a Partial Mayo Clinic score of 0 or 1, Steroid-free endoscopic response is defined as a Mayo endoscopy subscore of 1 or less, with a reduction of at least 1 point from baseline, Steroid-free clinical remission is defined as a Partial Mayo Clinic score of 0 or 1, Steroid-free endoscopic remission is defined as Endoscopic Mayo Clinic subscore of 0., Microbiota composition and diversity assessed by 16s sequencing at week 12 and 24, compared to baseline and to healthy volunteers donor’s microbiota., Proportion of adverse events in each group (Abdominal pain, Nausea, vomiting, fever, modified intestinal transit, an episode of infection), Inflammatory biological parameter: CRP, fecal calprotectin, platelet number, Endoscopic lesions at coloscopy and sigmoidoscopy (week 12) by endoscopic Mayo score and UCEIS score | — |
Countries
France
Outcome results
None listed