Elemental Formula Hypoallergenicity
Public ClinicalTrials.gov record NCT01569776. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Evaluation of Hypoallergenicity of an Amino Acid-Based Infant Formula
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of this clinical trial is to determine whether a new amino acid-based formula is hypoallergenic as defined by the American Academy of Pediatrics (2000), demonstrating that the test formula does not provoke allergenic activity in 90% of infants or children with confirmed cow's milk allergy (CMA) with 95% confidence as compared to a commercially available hypoallergenic formula.
Study identification
- NCT ID
- NCT01569776
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 37 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Months to 12 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 2012 (Type not available)
- Primary completion
- Apr 2013 (Actual)
- Completion
- Apr 2013 (Actual)
- Last update posted
- Jun 26, 2013
2012 – 2013
United States locations
- U.S. sites
- 9
- U.S. states
- 7
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pediatric Care Medical Group, Inc. | Huntington Beach | California | 92647 | — |
| Allergy & Asthma Medical Group and Research Center, A P.C. | San Diego | California | 92123 | — |
| Georgia Pollens Clinical Research Centers Inc. | Albany | Georgia | 31707 | — |
| Allergy & Asthma Physicians | Hinsdale | Illinois | 60521 | — |
| Deaconess Clinic, Inc. | Evansville | Indiana | 47713 | — |
| Mount Sinai Medical Center | New York | New York | 10029 | — |
| ENT & Allergy Associates | Newburgh | New York | 12550 | — |
| TTS Research | Boerne | Texas | 78006 | — |
| Clinical Research Partners | Richmond | Virginia | 25233 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01569776, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 26, 2013 · Synced Nov 2, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01569776 live on ClinicalTrials.gov.