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
Albuquerque, New Mexico 87109
Principal Investigator: Richard Wachs, MD
Phone: 856-417-6185
Click here to add this to my saved trials
145 Community Drive
Great Neck, New York 11021
Great Neck, New York 11021
Principal Investigator: Punita Ponda, MD
Click here to add this to my saved trials
6550 Fannin Street
Houston, Texas 77090
Houston, Texas 77090
Principal Investigator: Siddiqi, MD
Click here to add this to my saved trials
Huntington Beach, California 92648
Principal Investigator: Zabaneh, MD
Phone: 714-477-8080
Click here to add this to my saved trials
Memphis, Tennessee 38116
Principal Investigator: James Carter, MD
Click here to add this to my saved trials
Mountain View, California
Principal Investigator: Sayantani Sindher, MD
Phone: 650-724-0293
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73120
Principal Investigator: Martha Tarpay, MD
Phone: 405-286-9431
Click here to add this to my saved trials
Orangeburg, South Carolina 29118
Principal Investigator: John Ansley, MD
Phone: 803-378-1607
Click here to add this to my saved trials
Click here to add this to my saved trials
10330 Old Olive Street Road
Saint Louis, Missouri 63141
Saint Louis, Missouri 63141
Principal Investigator: Robert F Onder, MD
Click here to add this to my saved trials
Click here to add this to my saved trials