NL-OMON20641
Completed
Not Applicable
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 sites68 target enrollmentTBD
ConditionsCow's milk allergy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cow's milk allergy
- Sponsor
- Danone Research – Centre for Specialised Nutrition
- Enrollment
- 68
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
/A
Investigators
Eligibility Criteria
Inclusion Criteria
- •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).
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;
Outcomes
Primary Outcomes
Not specified
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