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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04059666
Recruitment Status : Recruiting
First Posted : August 16, 2019
Last Update Posted : March 16, 2021
Information provided by (Responsible Party):
Mead Johnson Nutrition

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 111 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 : March 5, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Comparison of stool microbiome between breast fed and formula fed babies [ Time Frame: Over 60 days ]
    Stool collection

Secondary Outcome Measures :
  1. Oral microbiome at each visit [ Time Frame: Over 60 days ]
    Buccal swab

  2. Stool molecules at each visit [ Time Frame: Over 60 days ]
    Stool sample

  3. 24 hour recall of formula intake [ Time Frame: 2 times over 60 days ]
    24 hour recall questionnaire

  4. Stool color and consistency [ Time Frame: 3 times over 60 days ]
    Color and consistency

  5. Medically confirmed adverse events [ Time Frame: 60 days ]
    Medically confirmed adverse events

  6. Stool pH [ Time Frame: Over 60 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 18 Days   (Child)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04059666

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Contact: Nancy Moore 812-429-5000
Contact: Steven S Wu, MD 812-429-7564

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United States, Alabama
Birmingham Pediatric Associates Recruiting
Birmingham, Alabama, United States, 35205
Contact: Rosanne Fowler, RN    205-933-8522   
Principal Investigator: Max Hale, MD         
United States, Florida
Children's Research, LLC Recruiting
Altamonte Springs, Florida, United States, 32701
Contact: Kerry Mullen    407-831-6200 ext 264   
Principal Investigator: Edward N Zissman, MD         
United States, Kentucky
Owensboro Pediatrics Recruiting
Owensboro, Kentucky, United States, 42303
Contact: Pam Yeiser    270-316-4223   
Principal Investigator: Michael Yeiser, MD         
United States, Tennessee
Holston Medical Group Recruiting
Kingsport, Tennessee, United States, 37660
Contact: Ashley Helton    423-857-2787   
Principal Investigator: Joseph Ley, MD         
Memphis & Shelby County Pediatric Recruiting
Memphis, Tennessee, United States, 38116
Contact: Renita Talley, NP    901-281-2099   
Principal Investigator: James E Carter, MD         
Sponsors and Collaborators
Mead Johnson Nutrition
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Responsible Party: Mead Johnson Nutrition Identifier: NCT04059666    
Other Study ID Numbers: 3390-1
First Posted: August 16, 2019    Key Record Dates
Last Update Posted: March 16, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No