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Fig. 1 | Trials

Fig. 1

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

Fig. 1

A parallel-group, placebo-controlled, randomised, double-blind ascending dose phase I study of dietary supplementation with B. infantis. Groups of healthy infants will receive increasing doses of B. infantis until it comprises 50 % of their gut microbiota, defined as the pharmacologically effective dose (ED). This figure arbitrarily designates Group 6 as receiving the ED of B. infantis. After the ED has been reached, two additional dose escalations will occur to determine the impact that additional B. infantis has on the gut microbiota. To satisfy Hanley’s Rule of Three, 30 infants will receive the highest dose of B. infantis. “X” represents the maximum recommended starting dose (MRSD). A modified Fibonacci Series (X, 2X, 3X, …) is used to guide the dose escalations. CFU colony-forming units

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Trials

ISSN: 1745-6215