Cow's milk allergy
Conditions
Interventions
Duration of intervention: 8 weeks + 18 weeks follow
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 3 hours per day at least 3 days a week over 3 week period). 3. If results of a Specific IgE test (RAST) for cow’s milk protein AND/OR prick test for cow’s milk are available (for test(s) previously performed), these are negative or without detectable serum IgE (<0.1 kU/L); 4. Expected minimum product intake (per day) at the end of week 2 of: A. Birth up to 6 months: 500ml; B. From 6 months to 8 months: 450ml; C. From 9 months onwards: 350ml; 5. Written informed consent provided by parents/ guardians, according to local law.
Exclusion criteria
Exclusion criteria: 1. Infants less than 2500 g at birth; 2. Infants less than 37 weeks gestation who require specific premature formula at the time of study entry; 3. Infants with severe concurrent illness; 4. Infants with functional gastrointestinal symptoms where atopy and food allergy is NOT suspected; 5. Infants with immune autoimmune or gluten sensitive enteropathy; 6. Infants with Food Protein-Induced Enterocolitis Syndrome (FPIES); 7. Infants who have acute or chronic diarrhea secondary to confirmed infectious gastroenteritis (laboratory tests positive); 8. Behavioural disorders with food aversion or food phobia; 9. Infants who have undergone gastrointestinal surgery such as bowel resection or stoma placement; 10. Infants with Down syndrome or other syndromes where functional gastrointestinal disorders are common; 11. Use of probiotic bacteria or probiotic containing drinks/supplements in the 4 weeks preceding study entry and during the study; 12. Use of systemic antibiotics or anti-mycotic drugs 4 weeks preceding study entry and during the study; 13. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements; 14. 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 |
|---|---|
| Counts of Bifidobacteria and counts of Eubacterium rectale/ Clostridium coccoides at week 0 and week 8 ( fluorescence in situ hybridization (FISH). | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the effects of an AAF with synbiotics compared to an AAF without synbiotics with respect to: 1. Stool characteristics in terms of colour, frequency and consistency at week 0, 1, 4 and 8; 2. Parameters of gut health and immune status:(Faecal secretory IgA and concentrations of Short Chain Fatty Acids (SCFA); butyrate, propionate and acetate) at week 0 and 8. A. Faecal secretory IgA; B. Faecal concentrations of Short Chain Fatty Acids (SCFA); butyrate, propionate and acetate. | — |
Contacts
Public ContactWillemien Sinke
Danone Research - Centre for Specialised Nutrition Bosrandweg 20
Outcome results
None listed