Probiotic Formula and Infant Growth

November 3, 2014 updated by: Société des Produits Nestlé (SPN)

ASSESSMENT OF GROWTH OF INFANTS FED FORMULA WITH PROBIOTICS

This is a growth study of full-term, formula-fed infants randomized to receive a partially hydrolyzed whey protein formula with and without probiotics for the first four months of life. It is hypothesized that there will be no difference in growth between the two groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

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

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • North Scottsdale Pediatric Associates
    • Georgia
      • Marietta, Georgia, United States, 30189
        • Pediatrics & Adolescent Medicine
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
        • Kentucky Pediatric Adult Research
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • PMG Research of Winston-Salem
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • PMG Research of Bristol
    • Texas
      • Tomball, Texas, United States, 77375
        • Pediatric Healthcare of Northwest Houston
    • Virginia
      • Vienna, Virginia, United States, 22180
        • Advanced Pediatrics

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

1 week to 2 weeks (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy newborn infant
  • Full-term
  • Birth weight > 2500 and < 4500 g
  • 14±3 days of age on enrollment
  • Exclusively formula-fed, singleton birth
  • Having obtained his/her legal representative's informed consent

Exclusion Criteria:

  • Known or suspected cow-milk allergy
  • Congenital illness or malformation that may affect infant feeding and/or growth
  • Significant prenatal and/or postnatal disease
  • Any readmission to hospital prior to enrollment
  • Receiving prescription medication or frequent use of over the counter medications except vitamin and mineral supplements
  • Has received intravenous antibiotic therapy or oral probiotic in the last 7 days
  • Currently participating in another clinical study
  • Cannot be expected to comply with treatment

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?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control infant formula
partially hydrolyzed whey infant formula
Other: Control infant formula
partially hydrolyzed whey infant formula consumed ad libitum throughout study
Experimental: test infant formula
partially hydrolyzed whey infant formula with probiotic
Other: Test infant formula
partially hydrolyzed whey formula with probiotic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
growth
Time Frame: 4 months
weight gain assessed monthly
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
other growth
Time Frame: 4 months
Length, head circumference will be measured at monthly visits
4 months
adverse events
Time Frame: 4 months
all adverse events will be documented throughout the study
4 months
stool characteristics
Time Frame: throughout study
stool frequency, color, consistency
throughout study
spit-up
Time Frame: throughout study
frequency of spit-up as reported by caregivers
throughout study
vomit
Time Frame: throughout study
frequency of vomitting as reported by caregivers
throughout study

Collaborators and Investigators

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

Sponsor

Société des Produits Nestlé (SPN)

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

December 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

November 14, 2011

First Submitted That Met QC Criteria

November 17, 2011

First Posted (Estimate)

November 22, 2011

Study Record Updates

Last Update Posted (Estimate)

November 4, 2014

Last Update Submitted That Met QC Criteria

November 3, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 10.01.US.INF

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.

Clinical Trials on Healthy

Clinical Trials on Control infant formula

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe