| Enrolment | Allocation | Post-allocation | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Timepoint | –t1 | 0 | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 17 | Week 24 | Week 25 | Week 36 | Week 52 | Week 78 |
Enrolment: | ||||||||||||||
 Eligibility screen | X |  |  |  |  |  |  |  |  |  |  |  |  |  |
 Informed consent | X |  |  |  |  |  |  |  |  |  |  |  |  |  |
 Allocation |  | X |  |  |  |  |  |  |  |  |  |  |  |  |
Interventions: | ||||||||||||||
 Dose #1 of B. infantis/placebo |  |  | X |  |  |  |  |  |  |  |  |  |  |  |
 Dose #2 of B. infantis/placebo |  |  |  | X |  |  |  |  |  |  |  |  |  |  |
 Infant stool collection |  |  | X | X | X | X | X | X |  | X |  | X | X | X |
 Breast milk collection |  |  | X (Day 7 of life) | X (Day 14 of life) |  |  |  | X (Day 42 of life) | X (Day 120 of life) |  | X (Day 180 of life) |  |  |  |
Assessments: | ||||||||||||||
 Identification of pharmacologically effective dose (ED) of B. infantis |  |  |  |  |  |  |  | X |  |  |  |  |  |  |
 Study visit |  |  | X | X |  |  |  | X |  | X |  | X | X | X |
 Adverse event survey |  |  | X | X |  |  |  | X |  | X |  | X | X | X |
 Analysis of stool oligosaccharides |  |  | X | X | X | X | X | X |  | X |  | X | X | X |
 Analysis of stool microbiota |  |  | X | X | X | X | X | X |  | X |  | X | X | X |
 Analysis of breast milk oligosaccharides |  |  | X (Day 7 of life) | X (Day 14 of life) |  |  |  | X (Day 42 of life) | X (Day 120 of life) |  | X (Day 180 of life) |  |  |  |