Hydrolyzed infant formula does not reduce the risk of type 1 diabetes

Reference

Writing Group for the TRIGR Study Group, Knip M, Akerblom HK, et al. Effect of hydrolyzed infant formula vs conventional formula on risk of type 1 diabetes. The TRIGR randomized clinical trial. JAMA 2018;319(1):38-48.

Synopsis

Evidence from pathophysiologic and observational studies suggest that exposure to certain proteins in early infancy may increase the risk of type 1 diabetes in children with a genetic susceptibility. These investigators identified newborn infants considered to be at high risk for type 1 diabetes because of a first-degree relative with type 1 diabetes and a specific human leukocyte antigen genotype. All mothers were encouraged to initially breastfeed as long as individually desired. In both groups, 50% to 60% of mothers breastfed over 6 months. Eligible infants randomly received (concealed allocation) assigned weaning to either an extensively hydrolyzed casein-based formula or a control formula composed of 80% intact cow's milk protein and 20% hydrolyzed milk protein. Both formulas had a similar taste and smell. Individuals who assessed outcomes remained masked to treatment group assignment. Complete follow-up occurred for 97% of participants for a median of 11.5 years. Using both intention-to-treat and per-protocol (exposure to the study formula for 60 days or longer and no exposure to bovine protein foods) analyses, no significant difference occurred in the development of type 1 diabetes in the intervention versus conventional formula group (8.4% vs 7.6%). There was also no significant difference in the median age at diagnosis. Similar linear growth and weight gain occurred in both treatment groups.