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the Prophylaxis of Recurrent Pouchitis After Fecal Microbiota Transplant in UC With Ileo-anal Anastomosis (POCA)

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ClinicalTrials.gov Identifier: NCT03524352
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : July 16, 2018
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Pouchitis Other: fecal microbiota Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Prospective Multicenter Randomized Controlled Double-blind Label Study of the Prophylaxis of Recurrent Pouchitis After Fecal Microbiota Transplant in UC With Ileo-anal Anastomosis
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : September 1, 2024
Estimated Study Completion Date : September 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Experimental: fecal microbiota Other: fecal microbiota
fecal microbiota in suspension

Placebo Comparator: placebo Other: Placebo
sterile saline




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Number of relapse rate according to physiological and endoscopic parameter (pochitis disease activity index) [ Time Frame: 24 weeks ]
  2. Number of relapse rate according to pochitis disease activity index (physiological and endoscopic parameter) [ Time Frame: 52 weeks ]
  3. Number of days within the transplantation and the instauration of an antibiotherapy or alternative treatment [ Time Frame: 52 weeks ]
  4. Number of adverse events [ Time Frame: 104 weeks ]
  5. Number of fecal microbiota engraftment by 16S sequencing [ Time Frame: 8 weeks ]
  6. Number of evolution of health-related to disability according to physiological and endoscopic parameter (pochitis disease activity index) [ Time Frame: weeks -5 ]
  7. Number of evolution of health-related to disability according to physiological and endoscopic parameter (pochitis disease activity index) [ Time Frame: 0 week ]
  8. Number of evolution of health-related to disability according to physiological and endoscopic parameter (pochitis disease activity index) [ Time Frame: 8 weeks ]
  9. Number of evolution of health-related to disability according to physiological and endoscopic parameter (pochitis disease activity index) [ Time Frame: 24 weeks ]
  10. 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female ≥ 18 years at the time of signing the informed consent form (ICF).
  • Subject must understand and voluntarily sign an ICF prior to conduct the study related assessments/procedure.
  • Willing and able to adhere to the study visit scheduled and other protocol requirements.
  • Subjects must have been operated with ileal pouch anal anastomosis (IPAA) with a duration of at least 6 month prior the screening visit.
  • Subject must have a diagnosis of recurrent pouchitis defined as at least 2 episodes in the last year or relapsing immediately after a reasonable response to antibiotherapy.
  • Subject must be in remission with a Pouchitis Disease Activity Index (PDAI) < 7 at the screening
  • Subject must affiliation with social security system or beneficiary from such system
  • Female of childbearing potential must have a negative pregnancy test at screening and must agree to practice effective methods of contraception

Exclusion Criteria:

  • Crohn disease or indeterminate colitis
  • Anastomotic stenosis
  • Subject with prior treatment by probiotic within 3 month prior to the transplantation visit
  • Subject with prior treatment by corticosteroids within 6 weeks prior to the transplantation visit
  • Subject with prior treatment by immunosuppressors within 3 month prior to the transplantation visit
  • Prior treatment with a biologic within 3 month prior the transplantation visit
  • Documented active infection of any kind in the last 6 months
  • Absolute neutrophil count (ANC) < 1.5 x 109 /L (1,500 mm3)
  • Infection with chronic HIV
  • Pregnant female or breastfeeding
  • Chronic medical or psychiatric disease that may interfere with subject's ability to comply with study procedures
  • Administration of investigational drug within 3 months prior to planned FMT
  • Adults under guardianship, Safeguard justice or trusteeship
  • Subject with difficulty in follow-up (vacation, job transfer, geographical distance, lack of motivation).
  • Patients with contraindication to colonoscopy or anesthesia (if necessary)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03524352


Contacts
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Contact: Trang POISSON +33 2 40 08 75 59 caroline.trang@chu-nantes.fr

Locations
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France
CHU of Nantes Recruiting
Nantes, France
Contact: Trang       caroline.trang@chu-nantes.fr   
Sponsors and Collaborators
Nantes University Hospital

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03524352     History of Changes
Other Study ID Numbers: RC17_0021
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nantes University Hospital:
recurrent pouchitis
fecal microbiota transplant
Additional relevant MeSH terms:
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Pouchitis
Ileitis
Enteritis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Ileal Diseases