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

• Sponsor: Mead Johnson Nutrition (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT04059666
• Collaborator: (none)
• Enrollment: 57
• Locations: 5
• Arms: 3
• Actual Duration (Months): 35
• Patients Per Site: 11.4
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Microbiome	Other: Investigational; Other: Control	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 57 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Other
• Official Title: Gastrointestinal Tract Microbiome in Healthy Term Infants Receiving Mother'S-own Breast Milk or Cow's Milk-based Infant Formulas
• Actual Study Start Date: Mar 5, 2019
• Actual Primary Completion Date: Feb 2, 2022
• Actual Study Completion Date: Feb 2, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Comparison of stool microbiome between breast fed and formula fed babies [Over 60 days]

   Stool collection

Secondary Outcome Measures

1. Oral microbiome at each visit [Over 60 days]

   Buccal swab

2. Stool molecules at each visit [Over 60 days]

   Stool sample

3. 24 hour recall of formula intake [2 times over 60 days]

   24 hour recall questionnaire

4. Stool color and consistency [3 times over 60 days]

   Color and consistency

5. Medically confirmed adverse events [60 days]

   Medically confirmed adverse events

6. Stool pH [Over 60 days]

   pH

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Days to 18 Days
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Birmingham Pediatric Associates	Birmingham	Alabama	United States	35205
2	Children's Research, LLC	Altamonte Springs	Florida	United States	32701
3	Owensboro Pediatrics	Owensboro	Kentucky	United States	42303
4	Holston Medical Group	Kingsport	Tennessee	United States	37660
5	Memphis & Shelby County Pediatric	Memphis	Tennessee	United States	38116

Sponsors and Collaborators

• Mead Johnson Nutrition

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mead Johnson Nutrition
• ClinicalTrials.gov Identifier: NCT04059666
• Other Study ID Numbers: 3390-1
• First Posted: Aug 16, 2019
• Last Update Posted: Aug 25, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 25, 2022