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

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 Overview

• Status: Terminated
• Conditions: Metabolomics
• Intervention / Treatment: Other: Control: Cow milk-based infant formula; Other: Experimental 1: Cow milk-based infant formula; Other: Experimental 2: Cow milk-based infant formula; Other: Experimental 3: Cow milk-based infant formula

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hainan
    • Haikou, Hainan, China
      • Hainan Province Women & Children Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week to 2 weeks (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control: Cow milk-based infant formula; Cow milk-based infant formula	Other: Control: Cow milk-based infant formula
Experimental: Experimental 1: Cow milk-based infant formula; Cow milk-based infant formula with prebiotics	Other: Experimental 1: Cow milk-based infant formula; Experimental 1: Cow milk-based infant formula with prebiotics
Experimental: Experimental 2: Cow milk-based infant formula; Cow milk-based infant formula with probiotics	Other: Experimental 2: Cow milk-based infant formula; Experimental 2: Cow milk-based infant formula with probiotics
Experimental: Experimental 3: Cow milk-based infant formula; Cow milk-based infant formula with prebiotics and probiotics	Other: Experimental 3: Cow milk-based infant formula; Experimental 3: Cow milk-based infant formula with prebiotics and probiotics
No Intervention: Human Milk Reference

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in fecal microbiota	3.5 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Head circumference measured at each study visit	Up to 3.5 months
Recall of gastrointestinal tolerance questionnaire at each study visit	Up to 3.5 months
Body Weight measured at each study visit	Up to 3.5 months
Body Length measured at each study visit	Up to 3.5 months
Recall of infant formula usage at each study visit	Up to 3.5 months
Medically-confirmed adverse events collected throughout the study period	Up to 3.5 months

Collaborators and Investigators

• Sponsor: Mead Johnson Nutrition
• Collaborators: Beijing Kangchen Technologies

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: October 26, 2016
• First Submitted That Met QC Criteria: October 26, 2016
• First Posted (Estimate): October 28, 2016

Study Record Updates

• Last Update Posted (Actual): August 20, 2018
• Last Update Submitted That Met QC Criteria: August 16, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 6026