Hypoallergenicity Evaluation of a New Extensively Hydrolyzed Formula
| Status: | Completed |
|---|---|
| Conditions: | Allergy |
| Therapuetic Areas: | Otolaryngology |
| Healthy: | No |
| Age Range: | Any - 4 |
| Updated: | 2/1/2019 |
| Start Date: | July 6, 2017 |
| End Date: | November 6, 2018 |
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.
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.
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
- Anaphylaxis to any food
- 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
We found this trial at
12
sites
Oklahoma City, Oklahoma 73120
Principal Investigator: Martha Tarpay, MD
Phone: 405-286-9431
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Albuquerque, New Mexico 87109
Principal Investigator: Richard Wachs, MD
Phone: 856-417-6185
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145 Community Drive
Great Neck, New York 11021
Great Neck, New York 11021
Principal Investigator: Punita Ponda, MD
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6550 Fannin Street
Houston, Texas 77090
Houston, Texas 77090
Principal Investigator: Siddiqi, MD
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Huntington Beach, California 92648
Principal Investigator: Zabaneh, MD
Phone: 714-477-8080
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Memphis, Tennessee 38116
Principal Investigator: James Carter, MD
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Mountain View, California
Principal Investigator: Sayantani Sindher, MD
Phone: 650-724-0293
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1428 Madison Ave
New York, New York 10029
New York, New York 10029
(212) 241-6500
Principal Investigator: Anna Nowak-Wegrzyn, MD
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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Orangeburg, South Carolina 29118
Principal Investigator: John Ansley, MD
Phone: 803-378-1607
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10330 Old Olive Street Road
Saint Louis, Missouri 63141
Saint Louis, Missouri 63141
Principal Investigator: Robert F Onder, MD
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