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Exploratory/Proof of Principle Microbiota Study

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ClinicalTrials.gov Identifier: NCT02500563
Recruitment Status : Completed
First Posted : July 16, 2015
Last Update Posted : July 28, 2017
Sponsor:
Collaborator:
Midwest Children's Health Research Institute
Information provided by (Responsible Party):
Mead Johnson Nutrition

Brief Summary:
This clinical trial will evaluate the stool of infants fed one of two infant formulas, which contain different types of proteins, or breast milk to determine if different proteins have an effect on the type of bacteria that enters and lives in an infant's intestine early in life.

Condition or disease Intervention/treatment Phase
Fecal Microbiota Other: Amino acid based infant formula Other: Extensively hydrolyzed casein infant formula Other: Mother's own breast milk Not Applicable

Detailed Description:
This clinical trial will evaluate the stool of infants fed one of two infant formulas, which contain different types of proteins, or breast milk to determine if different proteins have an effect on the type of bacteria that enters and lives in an infant's intestine early in life.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: Exploratory/Proof of Principle Microbiota Study
Actual Study Start Date : July 2015
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Casein

Arm Intervention/treatment
Active Comparator: Amino acid based infant formula Other: Amino acid based infant formula
Experimental: Extensively hydrolyzed casein infant formula Other: Extensively hydrolyzed casein infant formula
Mother's own breast milk Other: Mother's own breast milk



Primary Outcome Measures :
  1. Fecal microbiota measured at each visit [ Time Frame: 8 weeks ]
    Sequencing and composition of samples


Secondary Outcome Measures :
  1. Body weight measured at each visit [ Time Frame: 8 weeks ]
    Measurement collected with a calibrated infant scale

  2. Body length measured at each visit [ Time Frame: 8 weeks ]
    Measurement collected with a standardized length board

  3. Head circumference measured at each visit [ Time Frame: 8 weeks ]
    Measurement collected with a standardized measuring tape

  4. Parental recall of formula intake at each visit [ Time Frame: 8 weeks ]
  5. Stool collection at each visit [ Time Frame: 8 weeks ]
    Composite measure of pH and short chain fatty acids

  6. Serious adverse events collected throughout the study period [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Singleton, 1-7 days of age at registration or randomization
  • Term infant with appropriate birth weight for gestational age
  • Either solely formula fed or exclusively receiving mother's own breast milk
  • Signed Informed Consent and Protected Health Information

Exclusion Criteria:

  • Caesarean delivery
  • Infant was born from a mother with Type 1 diabetes
  • History of underlying metabolic or chronic disease or immunocompromised
  • Feeding difficulties or history of formula or human milk intolerance
  • Signs of acute infection of current use of antibiotics

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 ClinicalTrials.gov identifier (NCT number): NCT02500563


Locations
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United States, Nebraska
Midwest Children's Health Research Institue
Lincoln, Nebraska, United States, 68504
Sponsors and Collaborators
Mead Johnson Nutrition
Midwest Children's Health Research Institute
Investigators
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Study Director: Jon Vanderhoof, M.D. Mead Johnson and Company
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Responsible Party: Mead Johnson Nutrition
ClinicalTrials.gov Identifier: NCT02500563    
Other Study ID Numbers: 6032
First Posted: July 16, 2015    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
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Caseins
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action