Table 1

Visit form of the study

ExaminationsScreeningBaselineInterventionFollow-up
Time windowV1
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.