A prospective double blind randomised controlled study to evaluate the immunological benefits and clinical effects of an elimination diet using an amino acid formula (AAF) with an added pre-probiotic blend in infants with Cow's Milk Allergy (CMA).
Completed
- Conditions
- Infants with Cow's Milk Allergy
- Registration Number
- NL-OMON28608
- Lead Sponsor
- Danone Research – Centre for Specialised Nutrition
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 170
Inclusion Criteria
1. Infants < 13 months of age i.e. up to and including the day before the infant is 13 months of age;
2. Infants with a clinical history of reaction and sensitised to cow's milk by either blood CM specific IgE>0.1kU/L and/or Skin Prick Testing (SPT) wheal size >= 3mm before entering the study. The diagnosis of IgE mediated CMA should be confirmed by cow's milk challenge or history of an anaphylaxis reaction;
Exclusion Criteria
1. Infants in non-Asian countries less than 2500 g at birth. Infants in Asian countries less than 2250 g at birth;
2. Infants less than 37 weeks gestation and requires specific premature formula at the time of study entry;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary study endpoint is the proportion of the infants who develop oral tolerance to cow’s milk.
- Secondary Outcome Measures
Name Time Method 1. Maturation of the GI (immune) system in cow’s milk allergic infants;<br /><br>2. Effectiveness of the study product in the dietary management of CMA/food allergy;<br /><br>3. Frequency of other allergies (non-food).<br>