NCT02948114
Terminated
Not Applicable
The Effect of Feeding Infant Formula Containing Prebiotics and/or Probiotics
Mead Johnson Nutrition1 site in 1 country2 target enrollmentStarted: October 2016Last updated:
ConditionsMetabolomics
Overview
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Mead Johnson Nutrition
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Change in fecal microbiota
Overview
Brief Summary
The study is intended to evaluate the microorganisms found in infant stools when consuming study formulas containing prebiotics and/or probiotics compared to infants consuming mother's own breast milk.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 10 Days to 14 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Singleton, 10-14 days of age at registration/randomization
- •Term infant with birth weight of 2500 grams or more from a vaginal birth
- •Formula feeding infants must be on formula for at least 3 days
- •Human milk fed infants must have received mother's own breast milk from 1 day of age to study registration and mother has intention to exclusively provide mother's own breast milk for the duration of the study
- •Signed informed consent
Exclusion Criteria
- •History of underlying metabolic or chronic disease or immune compromised
- •Feeding difficulties or formula intolerance
Outcomes
Primary Outcomes
Change in fecal microbiota
Time Frame: 3.5 months
Secondary Outcomes
- Recall of infant formula usage at each study visit(Up to 3.5 months)
- Body Length measured at each study visit(Up to 3.5 months)
- Body Weight measured at each study visit(Up to 3.5 months)
- Recall of gastrointestinal tolerance questionnaire at each study visit(Up to 3.5 months)
- Medically-confirmed adverse events collected throughout the study period(Up to 3.5 months)
- Head circumference measured at each study visit(Up to 3.5 months)
Investigators
Study Sites (1)
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