Cow's milk allergy (CMA).
Conditions
Interventions
Duration of intervention:
Phase A: one day, twice
Phase B: two weeks.
Intervention group: extensively hydrolyzed whey protein based infant formula.
Control group: amio acid-based infant formula.
Sponsors
Danone Research - Centre for Specialised Nutrition
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children with cow's milk allergy, diagnosed by a double-blind, placebo-controlled food challenge (DBPCFC) within 4 weeks prior to study start; 2. Aged from birth to 24 months; 3. Expected daily intake of at least 500ml of the study product during phase B; 4. Written informed consent of both parents/caretakers.
Exclusion criteria
Exclusion criteria: 1. Children consuming mother's milk at the time of inclusion and during the trial; 2. Intolerance for lactose or any other component of the study product(s); 3. History of anaphylactic reaction, including severe cardiovascular symptoms (shock), severe laryngeal edema, and bronchus obstruction; 4. History of cardiovascular, gastrointestinal, hepatic, renal or respiratory chronic disease other than allergy; 5. Major congenital abnormalities; 6. Inability to adhere to protocol. instructions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase A: immediate and delayed allergic reactions to DBPCFC with the extensively hydrolyzed whey protein-based infant formula; Phase B: gastro-intestinal tolerability and allergic symptoms. | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase A: none; Phase B: product convenience. | — |
Contacts
Public ContactM. Roelofs
Danone Research - Centre for Specialised Nutrition P.O. Box 7005
Outcome results
None listed