Evaluation of the Efficacy of an Amino Acid Based Formula in Infants

September 15, 2014 updated by: Mead Johnson Nutrition
This clinical trial will evaluate the efficacy of an amino acid formula in infants with allergic manifestations.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

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

  • France
      • Boulogne Billancourt, France
        • Centre Médical
      • Lille, France
        • Hôpital Saint Vincent de Paul
      • Paris, France
        • Hopital Necker Enfants Malades
      • Paris, France
        • Hopital Armand Trousseau
      • Vandoeuvre Lés Nancy, France
        • Médecine Infantile 1

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 month to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Weight loss within the past 4 weeks
  • Infants 1-12 months of age feeding a hypoallergenic formula for at least 2 weeks
  • Birth weight greater than or equal to 1500 grams
  • Solely enteral fed
  • Infants with at least one persistent allergy symptom
  • No change in medication within 10 days of beginning the study and no plans for change during the first 10 days of the study
  • Signed informed consent

Exclusion Criteria:

  • History of underlying condition which, in the Investigator's opinion, could interfere with normal growth, development, or assessment of the participant
  • Metabolic disease requiring special attention

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: N/A
  • Interventional Model: Single Group Assignment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight gain
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Allergic manifestations
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

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

Sponsor

Mead Johnson Nutrition

Investigators

  • Principal Investigator: Delphine de Boissieu, M.D., Centre Médical

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

February 1, 2012

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

April 23, 2012

First Submitted That Met QC Criteria

April 23, 2012

First Posted (Estimate)

April 24, 2012

Study Record Updates

Last Update Posted (Estimate)

September 16, 2014

Last Update Submitted That Met QC Criteria

September 15, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6009

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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