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

Table 5 Study schedule for the patient [39]

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	X^a	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	X^e		X	X	X	X		X
Biotheque receiver (serum)			X
Stool Samples (Clostridium difficile toxin, parasite)								X
Stool Samples Fecalotheque^f			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

a: clinical PDAI
b: histology
c: tissutheque
d: CMV
e: Serology will be proceed to check the sero-concorance with the donor (CMV, EBV and toxoplasma gondii)
f: stool samples will be collected before the colonic preparation