AI-Powered Research

1. Infants <13 months of age i.e. up to and including the day before the infant is 13 months of age;
2. Clinical history or strong suspicion of an allergic reaction to cow’s milk protein AND WITH at least one of the following (gastrointestinal) symptoms present at study entry:
A. Chronic pPoor weight gain AFTER the dietary inclusion of cow’s milk protein;
B. Frequent (daily) regurgitation or vomiting whereby symptoms are RELATED to the cow’s milk protein and not merely functional vomiting;
C. Extended periods of diarrhoea with a negative stool examination (laboratory tests negative);
D. Soft stool constipation (with/without perianal rash NOT due to infection);
E. Blood in stool;
F. Iron deficiency anaemia due to occult or macroscopic blood loss in stools NOT due to infection or dietary insufficiency;
G. Endoscopically confirmed eosinophilic enteropathy;
H. Persistent distress or colic (> 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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Counts of Bifidobacteria and counts of Eubacterium rectale/ Clostridium coccoides at week 0 and week 8 ( fluorescence in situ hybridization (FISH).

Secondary Outcome Measures

Name	Time	Method
To assess the effects of an AAF with synbiotics compared to an AAF without synbiotics with respect to:<br>1. Stool characteristics in terms of colour, frequency and consistency at week 0, 1, 4 and 8;<br>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.<br>A. Faecal secretory IgA;<br>B. Faecal concentrations of Short Chain Fatty Acids (SCFA); butyrate, propionate and acetate.