Nourishing the Infant Gut Microbiome to Support Immune Health: Protocol of SUN (Seeding Through Feeding) Randomized Controlled Trial.

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dc.citation.volume13
dc.contributor.authorWall CR
dc.contributor.authorRoy NC
dc.contributor.authorMullaney JA
dc.contributor.authorMcNabb WC
dc.contributor.authorGasser O
dc.contributor.authorFraser K
dc.contributor.authorAltermann E
dc.contributor.authorYoung W
dc.contributor.authorCooney J
dc.contributor.authorLawrence R
dc.contributor.authorJiang Y
dc.contributor.authorGalland BC
dc.contributor.authorFu X
dc.contributor.authorTonkie JN
dc.contributor.authorMahawar N
dc.contributor.authorLovell AL
dc.contributor.editorMa S
dc.coverage.spatialCanada
dc.date.accessioned2024-09-24T21:37:21Z
dc.date.available2024-09-24T21:37:21Z
dc.date.issued2024-09-02
dc.description.abstractBackground: The introduction of complementary foods during the first year of life influences the diversity of the gut microbiome. How this diversity affects immune development and health is unclear. Objective: This study evaluates 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 and the development of the gut microbiome. Methods: This study is a double-blind, randomized controlled trial of mothers and their 6-month-old infants (up to n=300) who have not yet started solids. Infants are randomized into one of 3 groups: control arm (C), standard kūmara intervention (K), and a kūmara intervention with added banana powder product (K+) to be consumed daily for 4 months until the infant is approximately 10 months old. Infants are matched for sex using stratified randomization. Data are collected at baseline (prior to commencing solid food) and at 2 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, breast milk, feces (baseline and 4 months), and blood samples (baseline and 4 months). Results: The trial was approved by the Health and Disability Ethics Committee of the Ministry of Health, New Zealand (reference 20/NTA/9). Recruitment and data collection did not commence until January 2022 due to the COVID-19 pandemic. Data collection and analyses are expected to conclude in January 2024 and early 2025, respectively. Results are 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. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12620000026921; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378654 International Registered Report Identifier (IRRID): DERR1-10.2196/56772 JMIR Res Protoc 2024;13:e56772
dc.description.confidentialfalse
dc.format.paginatione56772-
dc.identifier.author-urlhttps://www.ncbi.nlm.nih.gov/pubmed/39222346
dc.identifier.citationWall CR, Roy NC, Mullaney JA, McNabb WC, Gasser O, Fraser K, Altermann E, Young W, Cooney J, Lawrence R, Jiang Y, Galland BC, Fu X, Tonkie JN, Mahawar N, Lovell AL. (2024). Nourishing the Infant Gut Microbiome to Support Immune Health: Protocol of SUN (Seeding Through Feeding) Randomized Controlled Trial.. JMIR Res Protoc. 13. (pp. e56772-).
dc.identifier.doi10.2196/56772
dc.identifier.eissn1929-0748
dc.identifier.elements-typejournal-article
dc.identifier.issn1929-0748
dc.identifier.numbere56772
dc.identifier.piiv13i1e56772
dc.identifier.urihttps://mro.massey.ac.nz/handle/10179/71514
dc.languageeng
dc.publisherJMIR Publications
dc.publisher.urihttps://www.researchprotocols.org/2024/1/e56772
dc.relation.isPartOfJMIR Res Protoc
dc.rights(c) The author/sen
dc.rights.licenseCC BY 4.0en
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/en
dc.subjectRTI
dc.subjectcomplementary feeding
dc.subjectcomplementary food
dc.subjectfeeding
dc.subjectgut microbiome
dc.subjectgut microbiota
dc.subjectimmune
dc.subjectimmune development
dc.subjectimmune system
dc.subjectinfancy
dc.subjectinfant
dc.subjectinfant health
dc.subjectkūmara
dc.subjectmicrobiome
dc.subjectprevalence
dc.subjectrespiratory tract infections
dc.subjectFemale
dc.subjectHumans
dc.subjectInfant
dc.subjectMale
dc.subjectDouble-Blind Method
dc.subjectGastrointestinal Microbiome
dc.subjectInfant Nutritional Physiological Phenomena
dc.subjectMusa
dc.subjectNew Zealand
dc.subjectRespiratory Tract Infections
dc.subjectRandomized Controlled Trials as Topic
dc.titleNourishing the Infant Gut Microbiome to Support Immune Health: Protocol of SUN (Seeding Through Feeding) Randomized Controlled Trial.
dc.typeJournal article
pubs.elements-id491354
pubs.organisational-groupCollege of Health
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