Candy 2016.

Methods	Eight‐week prospective randomised multi‐centre double‐blind controlled study
Participants	Seventy‐one full‐term infants with suspected non‐IgE‐mediated cow's milk allergy (36 infants in control group, 35 in active group) Cow's milk allergy participants presented predominantly with gastrointestinal symptoms, and 10% with dermatological symptoms Country: Netherlands
Interventions	Active: amino acid‐based formula (AAF) with synbiotics designed for dietary management of cow's milk allergy (prebiotic: chicory‐derived neutral oligofructose, long‐chain inulin 9:1 ratio, and concentration 0.63 g/100 mL; probiotic: Bifidobacterium breve M‐16V at a concentration 1.47 × 10⁹ CFUs/100 mL formula) Control: commercially available formula with AAF only Intake/instructions: participants were instructed to consume a minimum, age‐specific, daily formula intake from the end of week 2 (infants 0 to 6 months of age, 500 mL; 6 to 8 months of age, 450 mL; and 49 months of age, 350 mL) Duration of intervention: 8 weeks
Outcomes	Primary Bifidobacteria and Eubacterium rectale/Clostridium coccidioides (ER/CC) cluster as percentage of total faecal bacteria determined by fluorescent in situ hybridisation at 8 weeks Secondary SCORAD at 0 and 8 weeks Parents' diary data on (allergic) symptoms and stool characteristics at weeks 0 and 8 Secretory IgA and short‐chain fatty acids (SCFAs) in stool samples at 0 and 8 weeks. Same data collected also from reference group of non‐randomised healthy breastfed infants age‐matched with infants with cow's milk allergy at week 8 of intervention
Notes	Trial acronym: ASSIGN‐1 Register: NTR3979 (Netherlands Trial Register) Funding/Sponsor: Nutricia Research BV Contact: Willemien Sinke; willemien.sinke@nutricia.com