Trials / Completed
CompletedNCT01569776
Elemental Formula Hypoallergenicity
Evaluation of Hypoallergenicity of an Amino Acid-Based Infant Formula
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 37 (actual)
- Sponsor
- Société des Produits Nestlé (SPN) · Industry
- Sex
- All
- Age
- 2 Months – 12 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Amino Acid formula | Amino Acid baby formula |
| OTHER | Commercially available Amino Acid Formula | Hypoallergenic Baby formula |
Timeline
- Start date
- 2012-04-01
- Primary completion
- 2013-04-01
- Completion
- 2013-04-01
- First posted
- 2012-04-03
- Last updated
- 2013-06-26
Locations
9 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01569776. Inclusion in this directory is not an endorsement.