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

NCT02948114 | Terminated

• 1 other identifier: 6026
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolomics

Outcome Measures

Primary Outcomes (1)

• Change in fecal microbiota

  3.5 months

Secondary Outcomes (6)

• Body Weight measured at each study visit

  Up to 3.5 months

• Body Length measured at each study visit

  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

• Recall of gastrointestinal tolerance questionnaire at each study visit

  Up to 3.5 months

Study Arms (5)

Control: Cow milk-based infant formula

ACTIVE COMPARATOR

Cow milk-based infant formula

Other: Control: Cow milk-based infant formula

Experimental 1: Cow milk-based infant formula

EXPERIMENTAL

Cow milk-based infant formula with prebiotics

Other: Experimental 1: Cow milk-based infant formula

Experimental 2: Cow milk-based infant formula

EXPERIMENTAL

Cow milk-based infant formula with probiotics

Other: Experimental 2: Cow milk-based infant formula

Experimental 3: Cow milk-based infant formula

EXPERIMENTAL

Cow milk-based infant formula with prebiotics and probiotics

Other: Experimental 3: Cow milk-based infant formula

Human Milk Reference

NO INTERVENTION

Human Milk Reference

Interventions

Control: Cow milk-based infant formula OTHER

Control: Cow milk-based infant formula

Experimental 1: Cow milk-based infant formula OTHER

Experimental 1: Cow milk-based infant formula with prebiotics

Experimental 1: Cow milk-based infant formula

Experimental 2: Cow milk-based infant formula OTHER

Experimental 2: Cow milk-based infant formula with probiotics

Experimental 2: Cow milk-based infant formula

Experimental 3: Cow milk-based infant formula OTHER

Experimental 3: Cow milk-based infant formula with prebiotics and probiotics

Experimental 3: Cow milk-based infant formula

Eligibility Criteria

• Age: 10 Days - 14 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• History of underlying metabolic or chronic disease or immune compromised
• Feeding difficulties or formula intolerance

Sponsors & Collaborators

• Mead Johnson Nutrition: lead
• Beijing Kangchen Technologies: collaborator

Study Sites (1)

Hainan Province Women & Children Hospital

Haikou, Hainan, China

Location

Study Officials

• Steven Wu

  Mead Johnson Nutrition

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2016
• First Posted: October 28, 2016
• Study Start: October 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: August 20, 2018

Record last verified: 2018-08

Locations

CN (1)