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

This study is currently recruiting participants.
Verified March 2013 by Mead Johnson Nutrition
Sponsor:
Information provided by (Responsible Party):
Mead Johnson Nutrition
ClinicalTrials.gov Identifier:
NCT01584245
First received: April 23, 2012
Last updated: March 18, 2013
Last verified: March 2013
History of Changes
  Purpose

This clinical trial will evaluate the efficacy of an amino acid formula in infants with allergic manifestations.


Condition Intervention
Cow's Milk Allergy
 Other: Amino Acid formula

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Official Title: Evaluation of the Efficacy of an Amino Acid Based Formula in Infants

Resource links provided by NLM:

MedlinePlus related topics: Allergy
U.S. FDA Resources

Further study details as provided by Mead Johnson Nutrition:

Primary Outcome Measures:
  • Weight gain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Allergic manifestations [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: February 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   1 Month to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01584245

Contacts
Contact: Nancy Moore 812-483-1847 nancy.moore@mjn.com

Locations
France
Centre médical Recruiting
Boulogne Billancourt, France
Principal Investigator: Delphine de Boissieu, MD            
Centre médical Recruiting
Boulogne Billancourt, France
Sub-Investigator: Marie-Pierre Cordier, MD            
Hôpital Saint Vincent de Paul Recruiting
Lille, France
Sub-Investigator: Nicolas Kalach, MD            
Hôpital Armand Trousseau Recruiting
Paris, France
Sub-Investigator: Patrick Tounian, MD            
Hôpital Necker Enfants Malades Recruiting
Paris, France
Sub-Investigator: Florence Campeotto, MD            
Médecine Infantile 1 Recruiting
Vandoeuvre Lés Nancy, France
Sub-Investigator: Pascale Dumond, MD            
Sponsors and Collaborators
Mead Johnson Nutrition
Investigators
Principal Investigator: Delphine de Boissieu, M.D. Centre médical
  More Information

No publications provided

Responsible Party: Mead Johnson Nutrition
ClinicalTrials.gov Identifier: NCT01584245     History of Changes
Other Study ID Numbers: 6009
Study First Received: April 23, 2012
Last Updated: March 18, 2013
Health Authority: France: Comité de protection des personnes

Additional relevant MeSH terms:
Milk Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 21, 2013