Safety and Efficacy Study

October 4, 2021 updated by: Nestlé

Safety and Efficacy of a New Term Infant Formula Supplemented With A Prebiotic: a Doubleblind, Randomized, Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

239

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Philippines
      • Muntinlupa, Philippines, 1780
        • Asian Hospital and Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 weeks to 3 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Infant Formula
Experimental Infant Formula containing a prebiotic
Other: Experimental Infant Formula
Standard bovine milk-based term infant formula supplemented with a prebiotic, fed ad libitum
Active Comparator: Standard Infant Formula
Standard bovine milk-based term infant formula
Other: Standard Infant Formula
Standard bovine milk-based term infant formula, fed ad libitum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Growth
Time Frame: 150 days
weight gain velocity
150 days
Stool Consistency Score
Time Frame: 150 days
150 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: 150 days
weight in grams
150 days
Average Daily Stool Frequency
Time Frame: 150 days
150 days
Fecal Microbiota
Time Frame: 150 days
150 days
Fecal Markers
Time Frame: 150 days
150 days
Adverse Events
Time Frame: 150 days
150 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nestlé

Investigators

  • Principal Investigator: Elvira M Estorninos, MD, Asian Hospital and Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

January 20, 2016

First Submitted That Met QC Criteria

January 29, 2016

First Posted (Estimate)

February 2, 2016

Study Record Updates

Last Update Posted (Actual)

October 11, 2021

Last Update Submitted That Met QC Criteria

October 4, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 14.15.INF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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