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

This study has been terminated.
(Enough participants enrolled to provide adequate statistical power)
Information provided by (Responsible Party):
Mead Johnson Nutrition Identifier:
First received: April 23, 2012
Last updated: September 15, 2014
Last verified: September 2014
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:

Further study details as provided by Mead Johnson Nutrition:

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

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

Enrollment: 32
Study Start Date: February 2012
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Mead Johnson Nutrition Identifier: NCT01584245     History of Changes
Other Study ID Numbers: 6009
Study First Received: April 23, 2012
Last Updated: September 15, 2014

Additional relevant MeSH terms:
Milk Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases processed this record on September 21, 2017