Comparing Impacts of Donor Human Milk to Formula Supplementation on the Gut Microbiome of Full-term Infants - Trial NCT05815433
Access comprehensive clinical trial information for NCT05815433 through Pure Global AI's free database. This phase not specified trial is sponsored by University of Calgary and is currently Recruiting. The study focuses on Microbial Colonization. Target enrollment is 60 participants.
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Study Focus
Sponsor & Location
University of Calgary
Timeline & Enrollment
N/A
Jul 01, 2023
Dec 31, 2024
Primary Outcome
Infant gut microbiome - shallow shotgun metagenomics (RA),Infant gut microbiome - shallow shotgun metagenomics (RA),Infant gut microbiome - shallow shotgun metagenomics (RA),Infant gut microbiome - shallow shotgun metagenomics (alpha diversity),Infant gut microbiome - shallow shotgun metagenomics (alpha diversity),Infant gut microbiome - shallow shotgun metagenomics (alpha diversity),Infant gut microbiome - shallow shotgun metagenomics (beta diversity),Infant gut microbiome - shallow shotgun metagenomics (beta diversity),Infant gut microbiome - shallow shotgun metagenomics (beta diversity)
Summary
The goal of this pilot randomized controlled trial (RCT) is to examine donor human milk (DHM)
 as a clinical intervention targeted at achieving beneficial microbiome signatures in
 full-term infants who are exposed to intrapartum antibiotic prophylaxis (IAP) therapy during
 labour. Secondarily, this study aims to compare the infant health outcomes of sleep and
 growth between groups to assess if these outcomes are mediated by infant feeding type or
 potential differences in microbial signatures. Finally, this study will compare maternal
 outcomes of depression, anger, breastfeeding self-efficacy and breastfeeding rates between
 groups.
 
 The hypothesis of this study is: that replacing formula with DHM supplementation will
 minimize gut microbiome dysbiosis and foster homeostasis following supplementation. In
 addition, it is hypothesized that improved homeostasis will promote improved sleep and growth
 outcomes in participant infants. Finally, mothers whose infants receive DHM will have lower
 depression and anger scores and high breastfeeding self-efficacy and exclusive breastfeeding
 rates compared to mothers whose infants receive formula.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05815433
Non-Device Trial