Table 1

Flow chart of the study for children with IBD

Visit(V-1)V1V2 (+7 days)
Information processX
Written consent processX
Inclusion and exclusion criteria reviewX
Clinical assessmentX
Vital signs assessmentX
Anthropometric measurementsX
Blood sample processX
PCDAI/PUCAI questionnaire processX
Body composition measurementsX
Concomitant medication evaluationX
Quality of life/fatigue score assessmentX
AE and SAE monitoringX
Physical fitness measurementsX
Physical activity measurementsX
Phone callX
  • AE, adverse event; IBD, inflammatory bowel disease; PCDAI, Pediatric Crohn’s Disease Activity Index; PUCAI, Pediatric Ulcerative Colitis Activity Index; SAE, serious adverse event.