Growth, Safety and Tolerance of a Hydrolyzed Protein Infant Formula
NCT05618704 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 69
Last updated 2025-06-11
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.
Conditions
- Cow Milk Allergy
Interventions
- DIETARY_SUPPLEMENT
-
Hydrolyzed protein infant formula
The subjects will take the formula for 16 weeks
Sponsors & Collaborators
-
Nutricia Research
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 0 Days
- Max Age
- 8 Months
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-03-16
- Primary Completion
- 2024-10-14
- Completion
- 2025-05-12
Countries
- Poland
Study Locations
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