Skip to main content

Table 1 Schedule of study visits and specimen collections for each infant and mother

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

Week Visits and activities
Prior to starting the study • The patients’ parents or legal guardians will be asked to read and sign the consent form and will be instructed on the procedures for collection and storage of stool samples. They will be asked to refrain from giving the child any other dietary supplementation or probiotics while in the study and to inform the researchers if they are prescribed oral antibiotics at any time during the study.
Week 1 • Initial study visit, adverse event survey administration to parents and administration of first dose of B. infantis or placebo on day 7 of life.
• Week 1 stool samples collected (infants will have stool samples collected twice weekly for the first 6 weeks and then at the study visits at weeks 6, 24, 36, 52, and 78).
• If breastfeeding is discontinued at any point in the study, an additional series of six weekly stool samples will be collected following discontinuation in addition to the regularly scheduled collections
• Mother collects breast milk on day 7 of life.
Week 2 • Study visit, adverse event survey administration to parents and administration of second dose of B. infantis or placebo on day 14 of life.
• Week 2 stool samples collected
• Mother collects breast milk on day 14 of life.
Week 3 • Week 3 stool samples collected
• Adverse event survey administration to parents
Week 4 • Week 4 stool samples collected
• Adverse event survey administration to parents
Week 5 • Week 5 stool samples collected
Week 6 • Study visit, adverse event survey administration to parents.
• Week 6 stool sample collected.
• Mother collects breast milk on day 42 of life.
Week 17 • Mother collects breast milk on day 120 of life.
Week 24 • Study visit, adverse event survey administration to parents.
• Week 24 stool sample collected.
Week 25 • Mother collects breast milk on day 180 of life.
Week 36 • Study visit, adverse event survey administration to parents.
• Week 36 stool sample collected.
Week 52 • Study visit, adverse event survey administration to parents.
• Week 52 stool sample collected.
Week 78 • Study visit, adverse event survey administration to parents.
• Week 78 stool sample collected.