Table 1: Inclusion and exclusion criteria

From: A synbiotic-containing amino-acid-based formula improves gut microbiota in non-IgE-mediated allergic infants

Inclusion criteriaExclusion criteria
–Infants <13 months of age–Infants <2,500 g at birth
–Clinical history or strong suspicion of an allergic reaction to cow’s milk protein with at least one of the following gastrointestinal symptoms:–Infants <37 weeks of gestation requiring premature formula at study entry
(i) Chronic poor weight gain after dietary inclusion of cow’s milk protein–Infants with severe concurrent illness
(ii) Frequent regurgitation or vomiting, whereby symptoms are related to the cow’s milk protein–Infants with functional gastrointestinal symptoms, where atopy and food allergy is not suspected
(iii) Extended periods of diarrhea with a negative stool examination (lab test-negative)–Infants with (auto)immune and gluten-sensitive enteropathy
(iv) Soft stool constipationa (with/without perianal rash not due to infection)–Infants with FPIESb
(v) Blood in stool–Behavioral disorders with food aversion or food phobia
(vi) Iron deficiency anemia due to occult or macroscopic blood loss in stool not due to infection–Infants who have acute chronic diarrhea secondary to confirmed infectious gastroenteritis (lab test-positive)
(vii) Endoscopically confirmed eosinophilic enteropathy–Infants who have undergone gastrointestinal surgery (e.g., bowel resection, stoma)
(viii) Persistent distress or colic (>3 h/day, at least 3 days/week over a 3-week period)–Infants with Down’s syndrome or other syndromes, where functional gastrointestinal disorders are common
–If performed results of specific IgE tests and/or SPT for cow’s milk protein are negative–Use of probiotic bacteria or probiotic containing drinks/supplements/formula 4 weeks before study
–Expected minimum study formula intake per day at the end of week 2, 500 ml (0–6 months), 450 ml (6–8 months), and 350 ml (≥9 months)–Use of systemic antibiotics or antimycotics 4 weeks before study
  1. FPIES, Food Protein-Induced Enterocolitis Syndrome.
  2. aSoft stool constipation is a term used when a subject uses excessive straining to pass liquid or soft stool (with an occasional hard plug).
  3. bFPIES, which is associated with very severe symptoms, was excluded to reduce subject heterogeneity.