Trials / Recruiting
RecruitingNCT06456541
Infant Formula in Infants and Children With Cow's Milk Allergy
Determination of Hypoallergenicity of an Extensively Hydrolyzed Infant Formula in Infants and Children With Cow's Milk Allergy
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 61 (estimated)
- Sponsor
- Abbott Nutrition · Industry
- Sex
- All
- Age
- 3 Months – 12 Years
- Healthy volunteers
- Not accepted
Summary
This is a multi-center, randomized, double-blinded, placebo-controlled food challenge to be conducted in infants and children with confirmed IgE-mediated cow's milk allergy (CMA), followed by a 7-day open feeding of the experimental formula.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Experimental Extensively Hydrolyzed Formula | Experimental powder formula |
| OTHER | Placebo Extensively Hydrolyzed Formula | Placebo powder formula |
Timeline
- Start date
- 2024-10-01
- Primary completion
- 2028-07-01
- Completion
- 2029-01-01
- First posted
- 2024-06-13
- Last updated
- 2025-06-04
Locations
8 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT06456541. Inclusion in this directory is not an endorsement.