Hydrolyzed formula in susceptible infants does not reduce Diabetes-linked autoantibodies

1. Compared to the use of traditional cow’s milk-based formula, the use of hydrolyzed formula in genetically susceptible infants did not significantly reduce the number β-cell autoimmunity-related antibodies detected after 7 years. 

Evidence Rating Level: 1 (Excellent)       

Study Rundown: Type 1 diabetes is an autoimmune disorder in which the destruction of pancreatic β-islet cells results in insulin deficiency. Current evidence suggests that infantile exposure to complex proteins in genetically susceptible individuals may increase the risk of developing β-cell autoimmunity-related antibodies later in life. These antibodies can act as markers that may help predict the eventual development of β-cell autoimmunity and type 1 diabetes.

This study tested the hypothesis that providing an infant with a highly hydrolyzed formula would decrease the later development of autoantibodies and thus B-cell autoimmunity. It compared the use of highly hydrolyzed casein formula versus cow’s milk based formula in genetically susceptible infants. The primary outcome was positivity for > 2 autoantibodies over a period of 7 years.

This study was limited in its generalizability due to its inclusion of only genetically susceptible infants. Additionally, the role of breastfeeding in antibody development was not examined. Thus, future studies may aim to increase the generalizability of findings and capture the effects of breastfeeding on these outcome measures. Nevertheless, this study does not demonstrate a benefit to using hydrolyzed formula in infants at high risk for type 1 diabetes at this time.

Click to read the study, published today in JAMA

Relevant Reading: The Trial to Reduce IDDM in the Genetically at Risk (TRIGR) study: recruitment, intervention and follow-up

In-Depth [randomized controlled trial]: This study was a randomized controlled trial in which infants with HLA susceptibility and a first-degree relative with type 1 diabetes were randomized to either the casein hydrolyzed formula group (n=1081) or the cow’s milk formula group (n=1078). Islet cell antibodies were detected using indirect immunofluorescence and insulin autoantibodies, glutamic acid decarboxylase autoantibodies and tyrosine phosphatase-related insulinoma-associated molecule were detected with specific radiobinding assays. Over a median period of 7 years, 139 infants (13.4%) in the hydrolyzed formula group demonstrated positivity for > 2 autoantibodies versus 117 infants (11.4%) in the cow’s milk group formula group. The hazard risk for development of > 2 diabetes-associated autoantibodies in the hydrolyzed formula group was 1.21 (95% CI, 0.94-1.54), a statistically insignificant finding. The hazard risk for development of 1 autoantibody was 1.06 (95%CI, 0.93-1.22) and was also statistically insignificant.

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