Table 1.
Visit form of the study
| Examinations | Screening | Baseline | Intervention | Follow-up | ||||
| Time window |
V1
D-14~D-1 |
V2
D0 |
V3
D1 ~D30 |
V4
D31 ~D60 |
V5
D61 ~D90 |
V6
D91 ~D120 |
V7
D121 ~D150 |
V8
D151 ~D180 |
| Informed consent | ★ | |||||||
| Inclusion and exclusion criteria | ★ | |||||||
| Clinical assessment | ||||||||
| ABC | ★ | ★ | ★ | ★ | ★ | ★ | ★ | |
| CARS | ★ | ★ | ★ | ★ | ★ | ★ | ★ | |
| BSFS | ★ | ★ | ★ | ★ | ★ | ★ | ★ | |
| GSRS | ★ | ★ | ★ | ★ | ★ | ★ | ★ | |
| SASC | ★ | ★ | ★ | ★ | ★ | ★ | ★ | |
| Other symptoms | ★ | ★ | ★ | ★ | ★ | ★ | ★ | |
| Biological activity | ||||||||
| Stool samples | ★ | ★ | ★ | ★ | ★ | ★ | ||
| Urine samples | ★ | ★ | ★ | ★ | ★ | ★ | ||
| Blood samples | ★ | ★ | ★ | ★ | ★ | ★ | ||
| Saliva samples | ★ | ★ | ★ | ★ | ★ | ★ | ||
| Safety assessment | ||||||||
| Adverse events | ★ | ★ | ★ | ★ | ★ | ★ | ||
| Vital signs | ★ | ★ | ★ | ★ | ★ | ★ | ★ | |
| Physical examination | ★ | ★ | ★ | ★ | ★ | ★ | ★ | |
| Concomitant medications | ★ | ★ | ★ | ★ | ★ | ★ | ★ | |
| Haematology | ★ | ★ | ★ | ★ | ★ | ★ | ★ | |
| Biochemistry | ★ | ★ | ★ | ★ | ★ | ★ | ★ | |
| Urinalysis | ★ | ★ | ★ | ★ | ★ | ★ | ★ | |
| Infectious markers | ★ | ★ | ★ | ★ | ★ | ★ | ★ | |
| Records | ||||||||
| Capsules distribution | ★ | ★ | ★ | ★ | ||||
ABC, Autism Behavior Checklist; BSFC, Bristol Stool Form Scale; CARS, Childhood Autism Rating Scale; GSRS, Gastrointestinal Symptom Rating Scale; SASC, Social Anxiety Scale for Children.