The Effect of Feeding Infant Formula Containing Prebiotics and/or Probiotics
Not Applicable
Terminated
- Conditions
- Metabolomics
- Registration Number
- NCT02948114
- Lead Sponsor
- Mead Johnson Nutrition
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in fecal microbiota 3.5 months
- Secondary Outcome Measures
Name Time Method Recall of infant formula usage 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 Body Length measured at each study visit Up to 3.5 months Body Weight measured at each study visit Up to 3.5 months Head circumference measured at each study visit Up to 3.5 months
Trial Locations
- Locations (1)
Hainan Province Women & Children Hospital
🇨🇳Haikou, Hainan, China