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

NCT ID: NCT02948114

Last Updated: 2018-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-04-30

Brief Summary

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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

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Conditions

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Metabolomics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Control: Cow milk-based infant formula

Cow milk-based infant formula

Group Type ACTIVE_COMPARATOR

Control: Cow milk-based infant formula

Intervention Type OTHER

Experimental 1: Cow milk-based infant formula

Cow milk-based infant formula with prebiotics

Group Type EXPERIMENTAL

Experimental 1: Cow milk-based infant formula

Intervention Type OTHER

Experimental 1: Cow milk-based infant formula with prebiotics

Experimental 2: Cow milk-based infant formula

Cow milk-based infant formula with probiotics

Group Type EXPERIMENTAL

Experimental 2: Cow milk-based infant formula

Intervention Type OTHER

Experimental 2: Cow milk-based infant formula with probiotics

Experimental 3: Cow milk-based infant formula

Cow milk-based infant formula with prebiotics and probiotics

Group Type EXPERIMENTAL

Experimental 3: Cow milk-based infant formula

Intervention Type OTHER

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

Human Milk Reference

Human Milk Reference

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Control: Cow milk-based infant formula

Intervention Type OTHER

Experimental 1: Cow milk-based infant formula

Experimental 1: Cow milk-based infant formula with prebiotics

Intervention Type OTHER

Experimental 2: Cow milk-based infant formula

Experimental 2: Cow milk-based infant formula with probiotics

Intervention Type OTHER

Experimental 3: Cow milk-based infant formula

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

10 Days

Maximum Eligible Age

14 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beijing Kangchen Technologies

UNKNOWN

Sponsor Role collaborator

Mead Johnson Nutrition

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven Wu

Role: STUDY_DIRECTOR

Mead Johnson Nutrition

Locations

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Hainan Province Women & Children Hospital

Haikou, Hainan, China

Site Status

Countries

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China

Other Identifiers

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6026

Identifier Type: -

Identifier Source: org_study_id

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