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Table 5 Study schedule for the patient [39]

From: Impact of fecal microbiota transplantation on chronic recurrent pouchitis in ulcerative colitis with ileo-anal anastomosis: study protocol for a prospective, multicenter, double-blind, randomized, controlled trial

Study procedures V1
Week -2
Screening
+ or - 3 days
Week -1
Randomisation
V2
Week 0
Transplantation
V3
Week 8
+ or - 3 days
V4
Week 24
+ or - 7 days
V5
Week 52
+ or - 7 days
V6
Week 104
+ or - 7 days
Unscheduled Visit (relapse)
Written Informed Consent X        
Review of Inclusion, non inclusion Criteria X X       
Medical History (including UC disease history) & Demographics (including initials, date of birth, sex, tobacco status) X        
Pouchitis caracteristics and treatments X        
Physical Exam X    X X X X X
PDAI X    X X X Xa X
IBD-Disability Index X   X X X X X X
Flexible rectosigmoïdoscopy (FS) X   X X X X   X
Biopsies X (2)b   X (4)c X (6)b+c X (6)b+c X (6)b+c   X (7)b+c+d
Vital Signs X   X X X X X X
Blood samples : blood count, CRP Xe   X X X X   X
Biotheque receiver (serum)    X      
Stool Samples (Clostridium difficile toxin, parasite)         X
Stool Samples Fecalothequef    X X X    X
Prolongation of ATB until 48h prior to the transplantation X        
Fecal microbiota transplantation/ sham transplantation    X      
Adverse events    X X X X X X
Concomittant treatment X   X X X X X X
  1. a: clinical PDAI
  2. b: histology
  3. c: tissutheque
  4. d: CMV
  5. e: Serology will be proceed to check the sero-concorance with the donor (CMV, EBV and toxoplasma gondii)
  6. f: stool samples will be collected before the colonic preparation