University of Arizona
Tucson, Arizona, 85724, United States
NCT Number: NCT06059209
This study will compare infant gut bacteria for infants who have been fed a standard infant formula (Enfamil Infant); infants who have been fed a new infant formula designed to be more similar to breast milk (Enfamil NeuroPro); and breastfed infants. These formulas are currently available on the market and meet FDA requirements for infant formula.
This study is active but is not currently recruiting participants.
Notify Me0 month–4 month
All sexes
Interventional
Not applicable
Tucson, Arizona, 85724, United States
This study is a randomized, double-blind, parallel-group study comparing breast milk to Enfamil Infant and Enfamil NeuroPro formulas. The central hypothesis of the study is that the addition of milk fat globule membrane and2'-Fucosyllactose (2'-FL) to infant formula plays a role in shaping the microbiota in a manner similar to the microbiota of breastfed infants. To test this hypothesis, the investigators will explore longitudinal changes in the fecal microbiome from birth to 4 months of age in infants fed breast-milk, standard Enfamil Infant formula or Enfamil NeuroPro formula. Fecal samples will be collected at birth, and then monthly for 4 months. At the time of last collection one serum sample will be collected. The investigators will analyze basic growth parameters, fecal microbial community analysis by metagenomics, fecal metabolome by untargeted metabolomic analysis, and fecal and systemic indicators of inflammation and intestinal barrier function.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
FDA Infant formula
FDA Infant formula
Time frame: Birth to 4 months
Assessed using 16S amplicon profiling of stool samples
Time frame: Birth to 4 months
Samples sequenced using the NextSeq 500/550 and mapped against functional reference sequence databases using Bowtie2
Time frame: Birth to 4 months
Untargeted analysis by automated comparison of the ion features in the experimental samples to a reference library of chemical standard entries.
Time frame: Birth to 4 months
Measured periodically in centimeters as part of routine care
Time frame: Birth to 4 months
Measured periodically in centimeters as part of routine care
Time frame: Birth to 4 months
Measured periodically in kg as part of routine care
University of Arizona
Other
The Role of Milk Fat Globule Membrane and 2'-Fucosyllactose in the Infant Gut Microbiota
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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