Gastrointestinal Tract Microbiome in Healthy Term Infants Receiving Mother'S-own Breast Milk or Cow's Milk-based Infant Formulas

This clinical trial will compare stool and oral microbiome composition between infants fed breast milk or one of two infant formulas for a 60 day feeding period.

Study Overview

• Status: Terminated
• Conditions: Gastrointestinal Microbiome
• Intervention / Treatment: Other: Control; Other: Investigational

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Birmingham Pediatric Associates
  • Florida
    • Altamonte Springs, Florida, United States, 32701
      • Children's Research, LLC
  • Kentucky
    • Owensboro, Kentucky, United States, 42303
      • Owensboro Pediatrics
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Holston Medical Group
    • Memphis, Tennessee, United States, 38116
      • Memphis & Shelby County Pediatric

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week to 2 weeks (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 7-18 days of age at Visit 1
• Singleton birth
• Gestational age of 37-42 weeks
• Birth weight of 2500 g (5 lbs 8 oz) or more
• Parent or legal guardian agrees not to enroll infant in another interventional clinical study while participating in this study
• Signed informed consent and use of PHI for infant and birth mother
• Receipt of three protocol-compliant Baseline stool samples

Infants receiving formula:

• Exclusively receiving infant formula for at least 24 hours prior to randomization
• Parent(s) or legal guardian has full intention to exclusively feed study formula during the study period

Infants receiving human milk:

• Mother has intention to exclusively provide mother's-own breast milk for the duration of the study

Exclusion Criteria:

• Caesarean delivery
• Infant consumption of donor milk prior to randomization/registration
• Maternal antibiotic use within 48 hours prior to or at time of delivery
• Maternal antibiotic use while providing mother's-own breast milk to infant
• Infant use of systemic antibiotics prior to randomization/registration
• Any signs of an acute infection (i.e. fever, diarrhea) at randomization/registration
• Weight at Visit 1 is <95% of birth weight
• Infant use of probiotics
• Evidence of significant feeding difficulties
• Infant was born large for gestational age
• History of underlying metabolic or chronic disease or congenital malformation
• Infant is immunocompromised

Infants receiving human milk:

• Consumption of infant formula from 1 day of age

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Control	Other: Control; Cow's milk-based Infant Formula
EXPERIMENTAL: Investigational	Other: Investigational; Cow's milk-based Infant Formula with whey protein-lipid concentrate
NO_INTERVENTION: Mother's-own Breast Milk

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of stool microbiome between breast fed and formula fed babies	Stool collection	Over 60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral microbiome at each visit	Buccal swab	Over 60 days
Stool molecules at each visit	Stool sample	Over 60 days
24 hour recall of formula intake	24 hour recall questionnaire	2 times over 60 days
Stool color and consistency	Color and consistency	3 times over 60 days
Medically confirmed adverse events	Medically confirmed adverse events	60 days
Stool pH	pH	Over 60 days

Collaborators and Investigators

• Sponsor: Mead Johnson Nutrition

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 5, 2019
• Primary Completion (ACTUAL): February 2, 2022
• Study Completion (ACTUAL): February 2, 2022

Study Registration Dates

• First Submitted: May 8, 2019
• First Submitted That Met QC Criteria: August 14, 2019
• First Posted (ACTUAL): August 16, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 25, 2022
• Last Update Submitted That Met QC Criteria: August 22, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 3390-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No