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Table 2 Schedules for study participant enrolment, interventions and assessments in parallel-group, placebo-controlled, randomised, double-blind ascending dose phase I study of dietary supplementation with B. infantis

From: Dietary supplementation with Bifidobacterium longum subsp. infantis (B. infantis) in healthy breastfed infants: study protocol for a randomised controlled trial

  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)