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 |