NL-OMON39465
Completed
Phase 3
A randomized, double-blind, placebo-controlled intervention study to assess the therapeutic effect of an extensively hydrolyzed infant formula with an added synbiotic mixture in infants with atopic dermatitis. - SAINT
Danone Research - Centre for Specialised Nutrition0 sites144 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- atopic dermatitis
- Sponsor
- Danone Research - Centre for Specialised Nutrition
- Enrollment
- 144
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial ended prematurely
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Infants/children with atopic dermatitis
- •\- up to and includig 10 months of age
- •\- Expected daily intake of at least 500ml of the study product
Exclusion Criteria
- •\- Intolerance for any other component of the study product(s)
- •\- History of anaphylactic reaction to cow\*s milk protein, including severe cardiovascular symptoms (shock), severe laryngeal edema, and bronchus obstruction.
- •\- Use of antihistamines prior to (48 hours) the study.
- •\- Use of oral steroids prior to (4 weeks) the study.
- •\- Use of antibiotics or antimycotic drugs prior to (4 weeks) the study.
- •\- History or presence of cardiovascular, gastrointestinal, hepatic, renal or respiratory chronic disease other than allergy.
- •\- Major congenital abnormalities.
- •\- Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements.
Outcomes
Primary Outcomes
Not specified
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