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

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-26
• Study First Submitted QC: 2016-10-26
• Study First Posted: 2016-10-28
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-16
• Last Update Posted: 2018-08-20

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
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
Recall of infant formula usage at each study visit	Up to 3.5 months

Trial Locations

Locations (1)

Hainan Province Women & Children Hospital; 🇨🇳 Haikou, Hainan, China