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NCT01584245 Clinical Trial

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

Cow's Milk Allergy Clinical Trial

Official title:
Evaluation of the Efficacy of an Amino Acid Based Formula in Infants

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01584245
Other study ID # 6009
Secondary ID
Status Terminated
Phase N/A
First received April 23, 2012
Last updated September 15, 2014
Start date February 2012
Est. completion date July 2014

Study information
Verified date September 2014
Source Mead Johnson Nutrition
Contact n/a
Is FDA regulated No
Health authority France: Comité de protection des personnes
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Terminated
Enrollment 32
Est. completion date July 2014
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender Both
Age group 1 Month to 12 Months
Eligibility 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 Design

Intervention Model: Single Group Assignment

Related Conditions & MeSH terms

Intervention

Other:
• Amino Acid formula

Locations
Country Name City State
France 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

Sponsors (1)
Lead Sponsor Collaborator
Mead Johnson Nutrition

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Weight gain 12 weeks No
Secondary Allergic manifestations 12 weeks No
See also
  Status Clinical Trial Phase
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Completed NCT01634490 - Effects of Different Dietary Regimens on Tolerance Acquisition in Children With Cow's Milk Allergy N/A
Completed NCT01622426 - Tolerance to a New Free Amino Acid-based Formula in Children With IgE or Non-IgE-mediated Cow's Milk Allergy N/A
Completed NCT02466035 - Epigenetic Effects Involved in Children With Cow's Milk Allergy (EPICMA) N/A
Completed NCT02379598 - Effect of Therapy With Aminoacid Based Formula Versus Hydrolyzed Whey Proteins in Children With Cow's Milk Allergy N/A
Completed NCT04330092 - Diagnosis of Cow's Milk Protein Allergy
Not yet recruiting NCT02081651 - Parmigiano-Reggiano Cheese as a Possible Strategy to Acquire Oral Tolerance in Children With Cow's Milk Allergy Phase 3
Completed NCT03462030 - Baked Milk Oral Immunotherapy for Cow's Milk Allergy Phase 2
Completed NCT02465905 - Oral Immunotherapy in Cow's Milk Allergy (CMA) in Children : "Petit Lait" Study N/A
Suspended NCT05731206 - Hypoallergenicity of a Hydrolyzed Protein Infant Formula N/A
Not yet recruiting NCT06456541 - Infant Formula in Infants and Children With Cow's Milk Allergy N/A
Recruiting NCT02062476 - Epigenetic Effects Elicited By Lactobacillus GG In Children With Cow's Milk Allergy Phase 2
Completed NCT01589731 - Polymerized Beta-lactoglobulin Comparative Immunoreactivity N/A
Terminated NCT02405923 - Growth, Safety and Tolerance of a Rice Protein Hydrolysate Formula in Infants With Cow's Milk Protein Allergy N/A
Terminated NCT04910373 - Extensively Hydrolyzed Infant Formula in Infants and Children With Cow's Milk Allergy N/A
Recruiting NCT01968278 - Use of Baked Milk in Oral Immunotherapy for Severe IgE-mediated Cow's Milk Protein Allergic Patients N/A
Withdrawn NCT01470768 - Evaluation of Fatty Acid Levels and Growth in Infants Fed Amino Acid Based (AA) Formulas N/A
Recruiting NCT05883384 - Validity of Cow's Milk-related Symptom Score Among Children Suspected to Have Cow's Milk Protein Alergy