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NCT02450643 Clinical Trial

Evaluation of Hypoallergenicity of a New Extensively Hydrolyzed Formula

Cow's Milk Allergy Clinical Trial

Official title:
Evaluation of Hypoallergenicity of a New Extensively Hydrolyzed Formula

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02450643
Other study ID # 14.24.CLI
Secondary ID
Status Completed
Phase N/A
First received May 7, 2015
Last updated July 31, 2017
Start date April 2015
Est. completion date June 2017

Study information
Verified date July 2017
Source Nestlé
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Infants/children with cow's milk allergy will take part in 2 double-blinded placebo-controlled food challenges (DBPCFC) of 2 extensively hydrolyzed formulas in random order. If both food challenges are passed, subjects will be asked to consume the Test formula in an at-home open challenge for 7 days.

Recruitment information / eligibility
Status Completed
Enrollment 83
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender All
Age group 2 Months to 4 Years
Eligibility Inclusion Criteria:

- Born at term (>36 weeks gestation)

- 2 months to <4 years of age at enrollment

- Documented CMA within 6 months prior to enrollment

- Otherwise healthy

- Having obtained his/her legal representative's informed consent

Exclusion Criteria:

- Children consuming mother's milk at the time of inclusion and during the trial

- Any chromosomal or major congenital anomalies

- Chronic medical diseases (ie seizure disorders, chronic lung disease, heart problems (heart murmurs okay))

- Immunodeficiency

- Receiving free amino acid formula

- Subject who in the Investigator's assessment cannot be expected to adhere to the study protocol

- Currently participating in another clinical trial.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Test extensively hydrolyzed formula
extensively hydrolyzed formula made with a new enzyme
• Control extensively hydrolyzed formula
commercially available extensively hydrolyzed formula

Locations
Country Name City State
United States Allergy and Sinus Relief Center/Great Lakes Medical research Chardon Ohio
United States Atria Clinical Research Little Rock Arkansas
United States Allergy and Asthma Associates of Southern California Mission Viejo California
United States Mt. Sinai New York New York
United States ENT & Allergy Associates Newburgh New York
United States All Children's Hospital Saint Petersburg Florida
United States AeroAllergy Savannah Georgia
United States Allergy Asthma Research Institute Waco Texas

Sponsors (1)
Lead Sponsor Collaborator
Nestlé

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary allergic reaction number of children who react during a DBPCFC to either formula 2 hours post-DBPCFC
Secondary stool characteristics stool descriptors as collected on daily diaries 1 week
Secondary formula intake amount of formula ingested as collected on daily diaries 1 week
Secondary adverse events any adverse event reported by caregivers 1 week
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 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
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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