Table 2

Outcome measures and schedule of intervention and assessments

PeriodEnrolmentAllocation or baselineTreatment periodFollow-up period
Time points−1 week0 weeks5 weeks10 weeks15 weeks20 weeks24 weeks
EnrolmentEligibility screeningx
Informed consentsx
Characteristicx
Medical historyx
Laboratory examinationx
Biological specimensx
Random allocationx
InterventionProbioticsGraphic
PlaceboGraphic
AssessmentBMI for age z-scores will be analysed using WHO AnthroPlusxxxxxx
IgG will be assessed by electrochemiluminescence immunoassayxxx
α and β-gut microbiota diversity will be assessed by NGS of 16S ribosomal RNAxx
Monoclonal antibody affinity against SARS-CoV-2 will be assessed by competitive ELISAxxx
sIgA specific to SARS-CoV-2 titre concentrations assessed by competitive ELISAxxx
Dietary quality will be assessed by the Healthy Eating Index 2015 from 24-hour recall dataxxxxxx