We found no evidence to support short-term or prolonged feeding with a hydrolysed formula compared with exclusive breast feeding for prevention of allergic disease .
Very low- quality evidence indicates that short-term use of an EHF compared with a CMF may prevent infant CMA .
Further trials are recommended before implementation of this practice .We found no evidence to support prolonged feeding with a hydrolysed formula compared with a CMF for prevention of allergic disease in infants unable to be exclusively breast fed
BACKGROUND Infant formulas containing hydrolysed proteins have been widely advocated for preventing allergic disease in infants , in place of st and ard cow 's milk formula ( CMF ) .
However , it is unclear whether the clinical trial evidence supports this .
OBJECTIVES To compare effects on allergic disease when infants are fed a hydrolysed formula versus CMF or human breast milk .
If hydrolysed formulas are effective , to determine what type of hydrolysed formula is most effective , including extensively or partially hydrolysed formula ( EHF/PHF ) .
To determine whether infants at low or high risk of allergic disease , and whether infants receiving early short-term ( first few days after birth ) or prolonged formula feeding benefit from hydrolysed formulas .
Effect of Hydrolyzed Infant Formula vs Conventional Formula on Risk of Type 1 Diabetes: The TRIGR Randomized Clinical Trial
Importance Early exposure to complex dietary proteins may increase the risk of type 1 diabetes in children with genetic disease susceptibility . There are no intact proteins in extensively hydrolyzed formulas . Objective To test the hypothesis that weaning to an extensively hydrolyzed formula decreases the cumulative incidence of type 1 diabetes in young children . Design , Setting , and Participants An international double-blind r and omized clinical trial of 2159 infants with human leukocyte antigen – conferred disease susceptibility and a first-degree relative with type 1 diabetes recruited from May 2002 to January 2007 in 78 study centers in 15 countries ; 1081 were r and omized to be weaned to the extensively hydrolyzed casein formula and 1078 to a conventional formula .  The follow-up of the participants ended on February 28 , 2017 . Interventions The participants received either a casein hydrolysate or a conventional adapted cow ’s milk formula supplemented with 20 % of the casein hydrolysate . The minimum duration of study formula exposure was 60 days by 6 to 8 months of age . Main Outcomes and Measures Primary outcome was type 1 diabetes diagnosed according to World Health Organization criteria . Secondary outcomes included age at diabetes diagnosis and safety ( adverse events ) . Results Among 2159 newborn infants ( 1021 female [ 47.3 % ] ) who were r and omized , 1744 ( 80.8 % ) completed the trial . The participants were observed for a median of 11.5 years ( quartile [ Q ] 1-Q3 , 10.2 - 12.8 ) . The absolute risk of type 1 diabetes was 8.4 % among those r and omized to the casein hydrolysate ( n = 91 ) vs 7.6 % among those r and omized to the conventional formula ( n = 82 ) ( difference , 0.8 % [ 95 % CI , −1.6 % to 3.2 % ] ) . The hazard ratio for type 1 diabetes adjusted for human leukocyte antigen risk group , duration of breastfeeding , duration of study formula consumption , sex , and region while treating study center as a r and om effect was 1.1 ( 95 % CI , 0.8 to 1.5 ; P = .46 ) . The median age at diagnosis of type 1 diabetes was similar in the 2 groups ( 6.0 years [ Q1-Q3 , 3.1 - 8.9 ] vs 5.8 years [ Q1-Q3 , 2.6 - 9.1 ] ; difference , 0.2 years [ 95 % CI , −0.9 to 1.2 ] ) . Upper respiratory infections were the most common adverse event reported ( frequency , 0.48 events/year in the hydrolysate group and 0.50 events/year in the control group ) . Conclusions and Relevance Among infants at risk for type 1 diabetes , weaning to a hydrolyzed formula compared with a conventional formula did not reduce the cumulative incidence of type 1 diabetes after median follow-up for 11.5 years . These findings do not support a need to revise the dietary recommendations for infants at risk for type 1 diabetes . Trial Registration clinical trials.gov Identifier :
We found no evidence to support short-term or prolonged feeding with a hydrolysed formula compared with exclusive breast feeding for prevention of allergic disease .
Very low- quality evidence indicates that short-term use of an EHF compared with a CMF may prevent infant CMA .
Further trials are recommended before implementation of this practice .We found no evidence to support prolonged feeding with a hydrolysed formula compared with a CMF for prevention of allergic disease in infants unable to be exclusively breast fed
BACKGROUND Infant formulas containing hydrolysed proteins have been widely advocated for preventing allergic disease in infants , in place of st and ard cow 's milk formula ( CMF ) .
However , it is unclear whether the clinical trial evidence supports this .
OBJECTIVES To compare effects on allergic disease when infants are fed a hydrolysed formula versus CMF or human breast milk .
If hydrolysed formulas are effective , to determine what type of hydrolysed formula is most effective , including extensively or partially hydrolysed formula ( EHF/PHF ) .
To determine whether infants at low or high risk of allergic disease , and whether infants receiving early short-term ( first few days after birth ) or prolonged formula feeding benefit from hydrolysed formulas .