Ulcerative colitis (UC) is a chronic inflammatory digestive (IBD) disease medically treated with corticosteroids, aminosalicylates, immunomodulators, and biologics. Almost one third of UC patients will require surgical interventions because of fulminant colitis, dysplasia, cancer, or medical refractory diseases. Restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) is the current standard surgical intervention. Anastomotic leak, pouch failure, pelvic sepsis, and pouch ischemia can occur after the procedure, but the most common long-term complication is pouchitis, an idiopathic inflammatory condition involving the ileal reservoir. Symptoms of pouchitis are increased stool frequency, urgency, incontinence, bloody stools, abdominal or pelvic discomfort, fatigue, malaise, and fever. The prevalence of pouchitis ranges from 23 to 46 %, with an annual incidence up to 40 %. Though the majority of initial cases of pouchitis are easily managed with a short course of antibiotics, in about 5 to 15 % of cases, inflammation of the pouch becomes chronic with very few treatments available. Fecal microbiota transplantation (FMT) is a novel therapy to transfer normal intestinal flora from a healthy donor to a patient with a medical condition potentially caused by disrupted homeostasis of intestinal microbiota or dysbiosis. FMT has been widely used in refractory Clostridium difficile infection (CDI) and recently it has gained popularity for treatment of inflammatory bowel disease (IBD). Previous studies suggested that manipulating the composition of intestinal flora through antibiotics, probiotics, and prebiotic achieved significant results for treating acute episodes of UC-associated pouchitis. However, currently there is no established effective treatment for chronic antibiotic dependent pouchitis. Our project aims to evaluate the delay of relapse in chronic recurrent pouchitis after FMT versus sham transplantation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
42
fecal microbiota in suspension
sterile saline
CHU Angers
Angers, France
CHU Estaing
Clermont-Ferrand, France
Hopital Beaujon, Clichy
Clichy, France
CHU Henry Mondor
Créteil, France
CHU Claude Huriez
Lille, France
CHU Lyon Sud
Lyon, France
CHRU Nancy
Nancy, France
CHU of Nantes
Nantes, France
CHU de l'Archet 2
Nice, France
Hopital Saint Antoine
Paris, France
...and 3 more locations
Number of days between the date of transplantation and the date of relapse according to physiological and endoscopic parameter (pochitis disease activity index)
Time frame: 106 weeks
Number of relapse rate according to physiological and endoscopic parameter (pochitis disease activity index)
Time frame: 24 weeks
Number of relapse rate according to pochitis disease activity index (physiological and endoscopic parameter)
Time frame: 52 weeks
Number of days within the transplantation and the instauration of an antibiotherapy or alternative treatment
Time frame: 52 weeks
Number of adverse events
Time frame: 104 weeks
Number of fecal microbiota engraftment by 16S sequencing
Time frame: 8 weeks
Number of evolution of health-related to disability according to physiological and endoscopic parameter (pochitis disease activity index)
Time frame: weeks -5
Number of evolution of health-related to disability according to physiological and endoscopic parameter (pochitis disease activity index)
Time frame: 0 week
Number of evolution of health-related to disability according to physiological and endoscopic parameter (pochitis disease activity index)
Time frame: 8 weeks
Number of evolution of health-related to disability according to physiological and endoscopic parameter (pochitis disease activity index)
Time frame: 24 weeks
Number of evolution of health-related to disability according to physiological and endoscopic parameter (pochitis disease activity index)
Time frame: 52 weeks
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