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NCT01470768 Clinical Trial

Evaluation of Fatty Acid Levels and Growth in Infants Fed Amino Acid Based (AA) Formulas

Cow's Milk Allergy Clinical Trial

Official title:
Evaluation of Fatty Acid Levels and Growth in Infants Fed Amino Acid Based Formulas

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01470768
Other study ID # 6005
Secondary ID
Status Withdrawn
Phase N/A
First received October 26, 2011
Last updated March 20, 2012
Start date January 2012
Est. completion date December 2013

Study information
Verified date March 2012
Source Mead Johnson Nutrition
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Research Ethics Service (NRES) Committee London - Riverside
Study type Interventional

Clinical Trial Summary

This clinical trial will compare the amount of fatty acids in whole blood of babies fed one of two study formulas for 4 months.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group N/A to 6 Months
Eligibility Inclusion Criteria:

- 0 to 6 months of age inclusive

- Born at = 37 weeks gestation

- Birth weight of 2500 g (5 lb 8 oz) or more

- Infants suspected to be cow's milk allergic and who do not tolerate extensively hydrolyzed formula OR infants intolerant to breast milk

- Infants with symptoms suggestive of cow's milk allergy

- Signed Informed Consent

Exclusion Criteria:

- Infants who for whatever reasons were not discharged home as per routine

- Infants with metabolic illness requiring a special formula

- Infants fed with nasogastric tube

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Other:
• Amino Acid-based Formula with high DHA and ARA

• Amino Acid-based Formula with lower DHA and ARA

Locations
Country Name City State
United Kingdom Great Ormand Street Hospital and Institute of Child Health London United Kingdon

Sponsors (1)
Lead Sponsor Collaborator
Mead Johnson Nutrition

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Level of fatty acids in whole blood of infants 4 months No
Secondary body weight 4 months No
Secondary Occurrence of allergic manifestations 4 months No
Secondary Occurrence of adverse events 4 months No
Secondary Incidence of gas 4 months No
Secondary Incidence of fussiness 4 months No
Secondary Stool characteristics 4 months No
Secondary Body length 4 months No
Secondary Head Circumference 4 months No
See also
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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 NCT01634490 - Effects of Different Dietary Regimens on Tolerance Acquisition in Children With 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
Recruiting NCT05883384 - Validity of Cow's Milk-related Symptom Score Among Children Suspected to Have Cow's Milk Protein Alergy
Completed NCT01901380 - Cow's Milk Allergy and Functional Gastrointestinal Disorders N/A