Safety and Efficacy Study

NCT ID: NCT02670863

Last Updated: 2021-10-11

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

COMPLETED

Clinical Phase

NA

Total Enrollment

239 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-21

Study Completion Date

2017-05-31

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy of the experimental formula supplemented with a prebiotic vs the control formula.

Detailed Description

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Randomized, double-blind, controlled interventional clinical trial design. The purpose of this study is to evaluate the safety and efficacy of a new term infant formula supplemented with a prebiotic vs a standard infant formula fed for 150 days to healthy, term infants.

Conditions

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Infant Term Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental Infant Formula

Experimental Infant Formula containing a prebiotic

Group Type EXPERIMENTAL

Experimental Infant Formula

Intervention Type OTHER

Standard bovine milk-based term infant formula supplemented with a prebiotic, fed ad libitum

Standard Infant Formula

Standard bovine milk-based term infant formula

Group Type ACTIVE_COMPARATOR

Standard Infant Formula

Intervention Type OTHER

Standard bovine milk-based term infant formula, fed ad libitum

Interventions

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Experimental Infant Formula

Standard bovine milk-based term infant formula supplemented with a prebiotic, fed ad libitum

Intervention Type OTHER

Standard Infant Formula

Standard bovine milk-based term infant formula, fed ad libitum

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Written Informed Consent
* Infants whose parent(s)/LAR have reached the legal age of majority in the Philippines
* Infants whose parent(s)/LAR are willing and able to comply with study requirements
* Infants whose parent(s)/LAR are able to be contacted by telephone throughout the study
* Healthy term, singleton infant at birth
* Between 21 to 26 days post-natal age at enrollment visit
* Weight-for-length and head circumference-for-age z-scores \>/= - 3 and \</= +3 according to WHO Child Growth Standards
* Infants of parent(s)/LAR who have previously made the decision to formula feed their infant at the time of enrollment

Exclusion Criteria

* Infants with conditions requiring infant feedings other than those specified in the protocol
* Infants receiving complementary foods or liquids
* Infants who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results
* Infants who are presently receiving or have received medications that could interfere with the interpretation of study results
* Infants or infants whose parents/LAR cannot be expected to comply with the protocol or with study procedures
Minimum Eligible Age

21 Days

Maximum Eligible Age

26 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elvira M Estorninos, MD

Role: PRINCIPAL_INVESTIGATOR

Asian Hospital and Medical Center

Locations

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Asian Hospital and Medical Center

City of Muntinlupa, , Philippines

Site Status

Countries

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Philippines

Other Identifiers

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14.15.INF

Identifier Type: -

Identifier Source: org_study_id

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