NCT04059666

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 16, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2022

Completed
Last Updated

August 25, 2022

Status Verified

August 1, 2022

Enrollment Period

2.9 years

First QC Date

May 8, 2019

Last Update Submit

August 22, 2022

Conditions

Gastrointestinal Microbiome

Outcome Measures

Primary Outcomes (1)

  • Comparison of stool microbiome between breast fed and formula fed babies

    Stool collection

    Over 60 days

Secondary Outcomes (6)

  • Oral microbiome at each visit

    Over 60 days

  • Stool molecules at each visit

    Over 60 days

  • 24 hour recall of formula intake

    2 times over 60 days

  • Stool color and consistency

    3 times over 60 days

  • Medically confirmed adverse events

    60 days

  • +1 more secondary outcomes

Study Arms (3)

Control

ACTIVE COMPARATOR
Other: Control

Investigational

EXPERIMENTAL
Other: Investigational

Mother's-own Breast Milk

NO INTERVENTION

Interventions

InvestigationalOTHER

Cow's milk-based Infant Formula with whey protein-lipid concentrate

Investigational
ControlOTHER

Cow's milk-based Infant Formula

Control

Eligibility Criteria

Age7 Days - 18 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Birmingham Pediatric Associates

Birmingham, Alabama, 35205, United States

Location

Children's Research, LLC

Altamonte Springs, Florida, 32701, United States

Location

Owensboro Pediatrics

Owensboro, Kentucky, 42303, United States

Location

Holston Medical Group

Kingsport, Tennessee, 37660, United States

Location

Memphis & Shelby County Pediatric

Memphis, Tennessee, 38116, United States

Location

Related Publications (1)

  • Christensen C, Kok CR, Harris CL, Moore N, Wampler JL, Zhuang W, Wu SS, Hutkins R, Izard J, Auchtung JM. Microbiota, metabolic profiles and immune biomarkers in infants receiving formula with added bovine milk fat globule membrane: a randomized, controlled trial. Front Nutr. 2024 Oct 4;11:1465174. doi: 10.3389/fnut.2024.1465174. eCollection 2024.

    PMID: 39444571DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2019

First Posted

August 16, 2019

Study Start

March 5, 2019

Primary Completion

February 2, 2022

Study Completion

February 2, 2022

Last Updated

August 25, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(5)