Flow chart of the study for children with IBD
Visit | (V-1) | V1 | V2 (+7 days) |
Information process | X | ||
Written consent process | X | ||
Inclusion and exclusion criteria review | X | ||
Clinical assessment | X | ||
Vital signs assessment | X | ||
Anthropometric measurements | X | ||
Blood sample process | X | ||
PCDAI/PUCAI questionnaire process | X | ||
Body composition measurements | X | ||
Concomitant medication evaluation | X | ||
Quality of life/fatigue score assessment | X | ||
AE and SAE monitoring | X | ||
Physical fitness measurements | X | ||
Physical activity measurements | X | ||
Phone call | X |
AE, adverse event; IBD, inflammatory bowel disease; PCDAI, Pediatric Crohn’s Disease Activity Index; PUCAI, Pediatric Ulcerative Colitis Activity Index; SAE, serious adverse event.