A randomised, double-blind, controlled study to assess the effect of an Amino Acid based Formula with a synbiotic blend on gut microbiota diversity and clinical effectiveness in infants with suspected gastrointestinal non-IgE mediated Cow’s Milk Allergy.

Danone Research – Centre for Specialised Nutrition0 个研究点目标入组 68 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

•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.

•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.

发起方

Danone Research – Centre for Specialised Nutrition