Outcome measures and schedule of intervention and assessments
Period | Enrolment | Allocation or baseline | Treatment period | Follow-up period | ||||
Time points | −1 week | 0 weeks | 5 weeks | 10 weeks | 15 weeks | 20 weeks | 24 weeks | |
Enrolment | Eligibility screening | x | ||||||
Informed consents | x | |||||||
Characteristic | x | |||||||
Medical history | x | |||||||
Laboratory examination | x | |||||||
Biological specimens | x | |||||||
Random allocation | x | |||||||
Intervention | Probiotics | ![]() | ||||||
Placebo | ![]() | |||||||
Assessment | BMI for age z-scores will be analysed using WHO AnthroPlus | x | x | x | x | x | x | |
IgG will be assessed by electrochemiluminescence immunoassay | x | x | x | |||||
α and β-gut microbiota diversity will be assessed by NGS of 16S ribosomal RNA | x | x | ||||||
Monoclonal antibody affinity against SARS-CoV-2 will be assessed by competitive ELISA | x | x | x | |||||
sIgA specific to SARS-CoV-2 titre concentrations assessed by competitive ELISA | x | x | x | |||||
Dietary quality will be assessed by the Healthy Eating Index 2015 from 24-hour recall data | x | x | x | x | x | x |