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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)

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