The Effect of Feeding Infant Formula Containing Prebiotics and/or Probiotics

Mead Johnson Nutrition2 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

Conditions

Metabolomics

Interventions

Control: Cow milk-based infant formulaOTHER

Experimental 1: Cow milk-based infant formulaOTHER

Experimental 1: Cow milk-based infant formula with prebiotics

Experimental 2: Cow milk-based infant formulaOTHER

Experimental 2: Cow milk-based infant formula with probiotics

Eligibility

Sex: ALLMin age: 10 DaysMax age: 14 DaysHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Hainan Province Women & Children Hospital

Haikou, Hainan, China

Outcomes

Primary Outcomes

Change in fecal microbiota

Time frame: 3.5 months

Secondary Outcomes

Body Weight measured at each study visit

Time frame: Up to 3.5 months

Body Length measured at each study visit

Time frame: Up to 3.5 months

Head circumference measured at each study visit

Time frame: Up to 3.5 months

Recall of infant formula usage at each study visit

Time frame: Up to 3.5 months

Recall of gastrointestinal tolerance questionnaire at each study visit

Time frame: Up to 3.5 months

Medically-confirmed adverse events collected throughout the study period

Time frame: Up to 3.5 months

Data from ClinicalTrials.gov

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