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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
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Recruiting NCT05883384 - Validity of Cow's Milk-related Symptom Score Among Children Suspected to Have Cow's Milk Protein Alergy