Trials / Completed
CompletedNCT02450643
Evaluation of Hypoallergenicity of a New Extensively Hydrolyzed Formula
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 83 (estimated)
- Sponsor
- Société des Produits Nestlé (SPN) · Industry
- Sex
- All
- Age
- 2 Months – 4 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Test extensively hydrolyzed formula | extensively hydrolyzed formula made with a new enzyme |
| OTHER | Control extensively hydrolyzed formula | commercially available extensively hydrolyzed formula |
Timeline
- Start date
- 2015-04-01
- Primary completion
- 2017-06-01
- Completion
- 2017-06-01
- First posted
- 2015-05-21
- Last updated
- 2017-08-01
Locations
8 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02450643. Inclusion in this directory is not an endorsement.