NCT05815433

Comparing Impacts of Donor Human Milk to Formula Supplementation on the Gut Microbiome of Full-term Infants

Comparing Impacts of Donor Human Milk to Formula Supplementation on the Gut Microbiome of Full-term Infants Exposed to Antibiotics in Labour: A Pilot Randomized Controlled Trial
University of Calgary·ClinicalTrials.gov·otherRecruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Microbial Colonization
Drug/Device/Intervention
Donor Human Milk - Nutritional Replacement
Study type
Interventional
Intervention type
other
Sponsor & location
Primary sponsor
University of Calgary
Location
Calgary, Canada
Timeline & enrollment
Phase
N/A
Start date
Jul 01, 2023
End date
Dec 31, 2024
Enrollment
60 participants
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
Bacterial infection of unspecified siteOther bacterial infections of unspecified siteBacterial, viral and other infectious agentsCholeraOther specified bacterial intestinal infections
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05815433
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.