Trials / Completed
CompletedNCT05618704
Growth, Safety and Tolerance of a Hydrolyzed Protein Infant Formula
A Single Arm, Open Label Intervention Study of a Hydrolyzed Protein Formula to Evaluate Growth, Safety and Tolerance in Infants With a Clinical Diagnosis of Cow's Milk Allergy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 69 (actual)
- Sponsor
- Nutricia Research · Industry
- Sex
- All
- Age
- 0 Days – 8 Months
- Healthy volunteers
- Not accepted
Summary
This is a single arm, open label, multicenter intervention trial to evaluate growth parameters, cow's milk related symptoms, gastrointestinal tolerance and safety in infants with cow's milk allergy receiving a hydrolyzed protein formula.
Detailed description
The main purpose of this study is to demonstrate adequate growth over a 16-week intervention period in cow's milk allergic infants receiving a hydrolyzed protein formula.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Hydrolyzed protein infant formula | The subjects will take the formula for 16 weeks |
Timeline
- Start date
- 2023-03-16
- Primary completion
- 2024-10-14
- Completion
- 2025-05-12
- First posted
- 2022-11-16
- Last updated
- 2025-06-11
Locations
1 site across 1 country: Poland
Source: ClinicalTrials.gov record NCT05618704. Inclusion in this directory is not an endorsement.