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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01584245
Recruitment Status : Terminated (Enough participants enrolled to provide adequate statistical power)
First Posted : April 24, 2012
Last Update Posted : September 16, 2014
Information provided by (Responsible Party):
Mead Johnson Nutrition

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

Condition or disease Intervention/treatment
Cow's Milk Allergy Other: Amino Acid formula

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Official Title: Evaluation of the Efficacy of an Amino Acid Based Formula in Infants
Study Start Date : February 2012
Primary Completion Date : July 2014
Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Weight gain [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Allergic manifestations [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   1 Month to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01584245

Centre médical
Boulogne Billancourt, France
Hôpital Saint Vincent de Paul
Lille, France
Hôpital Armand Trousseau
Paris, France
Hôpital Necker Enfants Malades
Paris, France
Médecine Infantile 1
Vandoeuvre Lés Nancy, France
Sponsors and Collaborators
Mead Johnson Nutrition
Principal Investigator: Delphine de Boissieu, M.D. Centre médical

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Mead Johnson Nutrition Identifier: NCT01584245     History of Changes
Other Study ID Numbers: 6009
First Posted: April 24, 2012    Key Record Dates
Last Update Posted: September 16, 2014
Last Verified: September 2014

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