Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jan 25, 2024
Date Accepted: Jun 21, 2024
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Seeding through Feeding: Nourishing the Infant Gut Microbiome to Support Immune Health “The SUN Study”. Protocol of a Randomized Controlled Trial
ABSTRACT
Background:
The introduction of complementary food during the first year of life influences the diversity of the gut microbiome. How this diversity affects immune development and health is unclear.
Objective:
To evaluate the effect of consuming kūmara or kūmara with added banana powder (resistant starch) compared to a reference control at 4 months post-randomization on the prevalence of respiratory tract infections (RTI) and the development of the gut microbiome.
Methods:
This study is a double-blind, randomized controlled trial mothers and their 6 months old infants (up to n=300) who have not yet started solids. Infants are randomized into one of three groups: control arm (C), standard kūmara intervention (K), and a kūmara intervention with added banana powder product (K+) to be consumed daily for a period of 4 months, until the infant is approximately 10 months old. Infants are matched for sex using stratified randomization. Data is collected at baseline (prior to commencing solid food), and at 2 months and 4 months after commencing solid food (at around 8 and 10 months of age). Data and samples collected at each timepoint include: weight and length, intervention adherence (months 2 and 4), illness and medication history, dietary intake (months 2 and 4), sleep (diary and actigraphy), maternal dietary intake, and breast milk, feces (baseline and 4 months), and blood samples (baseline and 4 months).
Results:
The RCT was approved by the Health and Disability Ethics Committee (HDEC) of the Ministry of Health, New Zealand (HDEC reference 20/NTA/9). Recruitment and data collection did not commence until January 2022 due to the COVID pandemic. Data collection and analyses are expected to conclude in May 2024 and September 2024, respectively. Results to be published in 2024 and 2025.
Conclusions:
The results of this study will help us understand how the introduction of a specific prebiotic complementary food affects the microbiota and relative abundances of the microbial species, the modulation of immune development and infant health. It will contribute to the expanding body of research that aims to deepen our understanding of the connections between nutrition, gut microbiota, and early-life postnatal health. Clinical Trial: Australia, New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000026921
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