Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Exploratory/Proof of Principle Microbiota Study

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. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 15, 2015
First Posted Date  ICMJE July 16, 2015
Last Update Posted Date July 28, 2017
Actual Study Start Date  ICMJE July 2015
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2015)
Fecal microbiota measured at each visit [ Time Frame: 8 weeks ]
Sequencing and composition of samples
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2015)
  • Body weight measured at each visit [ Time Frame: 8 weeks ]
    Measurement collected with a calibrated infant scale
  • Body length measured at each visit [ Time Frame: 8 weeks ]
    Measurement collected with a standardized length board
  • Head circumference measured at each visit [ Time Frame: 8 weeks ]
    Measurement collected with a standardized measuring tape
  • Parental recall of formula intake at each visit [ Time Frame: 8 weeks ]
  • Stool collection at each visit [ Time Frame: 8 weeks ]
    Composite measure of pH and short chain fatty acids
  • Serious adverse events collected throughout the study period [ Time Frame: 8 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exploratory/Proof of Principle Microbiota Study
Official Title  ICMJE Exploratory/Proof of Principle Microbiota Study
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Condition  ICMJE Fecal Microbiota
Intervention  ICMJE
  • Other: Amino acid based infant formula
  • Other: Extensively hydrolyzed casein infant formula
  • Other: Mother's own breast milk
Study Arms  ICMJE
  • Active Comparator: Amino acid based infant formula
    Intervention: Other: Amino acid based infant formula
  • Experimental: Extensively hydrolyzed casein infant formula
    Intervention: Other: Extensively hydrolyzed casein infant formula
  • Mother's own breast milk
    Intervention: Other: Mother's own breast milk
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 27, 2017)
78
Original Estimated Enrollment  ICMJE
 (submitted: July 15, 2015)
80
Actual Study Completion Date  ICMJE July 2017
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 7 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02500563
Other Study ID Numbers  ICMJE 6032
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mead Johnson Nutrition
Study Sponsor  ICMJE Mead Johnson Nutrition
Collaborators  ICMJE Midwest Children's Health Research Institute
Investigators  ICMJE
Study Director: Jon Vanderhoof, M.D. Mead Johnson and Company
PRS Account Mead Johnson Nutrition
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP