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

Gastrointestinal Microbiome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04059666
• Other study ID #: 3390-1
• Status: Terminated
• Phase: N/A
• Start date: March 5, 2019
• Est. completion date: February 2, 2022

Study information

• Verified date: August 2022
• Source: Mead Johnson Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 57
• Est. completion date: February 2, 2022
• Est. primary completion date: February 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Days to 18 Days

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Microbiome

Intervention

Other:
• Investigational
Cow's milk-based Infant Formula with whey protein-lipid concentrate
• Control
Cow's milk-based Infant Formula

Locations

Country	Name	City	State
United States	Children's Research, LLC	Altamonte Springs	Florida
United States	Birmingham Pediatric Associates	Birmingham	Alabama
United States	Holston Medical Group	Kingsport	Tennessee
United States	Memphis & Shelby County Pediatric	Memphis	Tennessee
United States	Owensboro Pediatrics	Owensboro	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Mead Johnson Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of stool microbiome between breast fed and formula fed babies	Stool collection	Over 60 days
Secondary	Oral microbiome at each visit	Buccal swab	Over 60 days
Secondary	Stool molecules at each visit	Stool sample	Over 60 days
Secondary	24 hour recall of formula intake	24 hour recall questionnaire	2 times over 60 days
Secondary	Stool color and consistency	Color and consistency	3 times over 60 days
Secondary	Medically confirmed adverse events	Medically confirmed adverse events	60 days
Secondary	Stool pH	pH	Over 60 days