The Effects on Growth of a Non-Routine Infant Formula

April 10, 2008 updated by: Mead Johnson Nutrition

The Effects on Growth and Tolerance of Hydrolyzed Formulas Fed to Term Infants

A study to evaluate the growth and development of term infants fed either an extensively hydrolyzed formula with probiotics, a partially hydrolyzed formula with probiotics, or an extensively hydrolyzed formula without probiotics

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

293

Phase

  • Not Applicable

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Term infant
  • Solely formula fed
  • 14 days of age

Exclusion Criteria:

  • History of underlying disease
  • Evidence of formula intolerance
  • Current illness

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2
Other: infant formula
  1. hydrolyzed infant formula without probiotics
  2. hydrolyzed infant formula with probiotics
  3. hydrolyzed infant formula with probiotics
Other Names:
  • no other names for any of the intervention arms
Experimental: 3
Other: infant formula
  1. hydrolyzed infant formula without probiotics
  2. hydrolyzed infant formula with probiotics
  3. hydrolyzed infant formula with probiotics
Other Names:
  • no other names for any of the intervention arms
Active Comparator: 1
Other: infant formula
  1. hydrolyzed infant formula without probiotics
  2. hydrolyzed infant formula with probiotics
  3. hydrolyzed infant formula with probiotics
Other Names:
  • no other names for any of the intervention arms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Growth (weight)
Time Frame: 106 days
106 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Tolerance
Time Frame: 106 days
106 days

Collaborators and Investigators

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

Sponsor

Mead Johnson Nutrition

Investigators

  • Study Director: Deolinda Scalabrin, MD, Mead Johnson Nutrition

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2006

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

March 28, 2008

First Submitted That Met QC Criteria

April 9, 2008

First Posted (Estimate)

April 10, 2008

Study Record Updates

Last Update Posted (Estimate)

April 15, 2008

Last Update Submitted That Met QC Criteria

April 10, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 3369-5

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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