Study to test a new infant formula for cow's milk allergic infants
Phase 2
Completed
- Conditions
- <p>Children with cow's milk allergy.</p>10001708
- Registration Number
- NL-OMON21357
- Lead Sponsor
- utricia Research BV
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 25
Inclusion Criteria
- Children with a documented cow’s milk allergy, confirmed by one of the following criteria, within two months prior to first DBPCFC (visit 2):
o Positive double-blind, placebo-controlled oral food challenge (DBPCFC) with cow’s milk OR
Exclusion Criteria
- Children who receive breastfeeding more than twice daily during the week before inclusion.
- Confirmed history of acute severe, potentially life threatening reaction after isolated accidental ingestion of cow’s milk e.g. history of anaphylactic reaction, including severe cardiovascular symptoms, severe laryngeal edema, and bronchus obstruction.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Incidence of immediate and/or delayed allergic reactions to the DBPCFC and/or a subsequent open challenge with the test product during phase A of the study.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Anthropometrics<br /><br>- Gastro-intestinal tolerability (e.g. abdominal cramps)<br /><br>- Faecal characteristics (stool frequency/consistency)</p><br>