Infants with Cow's Milk Allergy
Conditions
Interventions
Duration of intervention: 12 months.
Intervention group: AAF with prebiotics and probiotics (synbiotics) formulation.
Control group: AAF without synbiotics.
Sponsors
Danone Research – Centre for Specialised Nutrition
Eligibility
Inclusion criteria
Inclusion criteria: 1. Infants 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; 3. Infants expected to consume the required amount of formula during the study intervention.
Exclusion criteria
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; 3. Infants with severe concurrent illness; 4. Use of anti- histamines in the 4 days preceding study entry; 5. Use of systemic corticosteroids in the 4 weeks preceding study entry and not willing to exclude corticosteroids in the 4 weeks preceding each study visit; 6. Use of probiotic bacteria or probiotic containing drinks/supplements; 7. Use of systemic antibiotics or anti-mycotic drugs 4 weeks preceding study entry; 8. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements; 9. Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study endpoint is the proportion of the infants who develop oral tolerance to cow’s milk. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Maturation of the GI (immune) system in cow’s milk allergic infants; 2. Effectiveness of the study product in the dietary management of CMA/food allergy; 3. Frequency of other allergies (non-food). | — |
Contacts
Public ContactNutricia Research
Nutricia Research - Advanced Medical Nutrition;
Outcome results
None listed