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 .
The Trial to Reduce IDDM in the Genetically at Risk (TRIGR) study: recruitment, intervention and follow-up
Aims /hypothesisThe Trial to Reduce  IDDM  in the Genetically at Risk ( TRIGR ) study was design ed to establish whether weaning to a highly hydrolysed formula in infancy subsequently reduces the risk of type 1 diabetes . Methods The study population comprises newborn infants who have first-degree relatives with type 1 diabetes and meet the increased risk HLA inclusion , but not exclusion criteria . The study is being performed in 15 countries in three continents . First-degree relatives of patients with type 1 diabetes were identified from diabetes clinics , diabetes registries , and from other endocrinology or obstetrics offices and websites . HLA typing was performed at birth from cord or heel stick blood , and the results sent to the study ’s Data Management Unit within 2 weeks for communication of eligibility to the clinical study centre . All mothers recruited were encouraged to breastfeed . The intervention lasted for 6 to 8 months , and weaning formulas based on hydrolysed casein and st and ard cow ’s milk were compared . Results TRIGR recruited 5,606 infants , of whom 2,160 were enrolled as eligible participants , 6 % more than the target of 2,032 . Of those enrolled , 80 % were exposed to the study formula . The overall retention rate over the first 5 years is 87 % , with protocol compliance at 94 % . The r and omisation code will be opened when the last recruited child turns 10 years of age , i.e. in 2017 . Conclusions /interpretationThe TRIGR experience demonstrates the feasibility and successful implementation of an international dietary intervention study . TRIGR is the first ever primary prevention trial for type 1 diabetes and , if completed successfully , will provide a definite answer to the research question .Trial registration Clinical Trials.gov NCT00179777 Funding The study was funded by the National Institute of Child Health and Development ( NICHD ) and National Institute of Diabetes and Digestive and Kidney Diseases ( NIDDK ) , National Institutes of Health ( NIH ) ( grant numbers HD040364 , HD042444 and HD051997 ) , Canadian Institutes of Health Research , the Juvenile Diabetes Research Foundation International and the Commission of the European Communities ( specific RTD programme ‘ Quality of Life and Management of Living Re sources ’ , contract number QLK1 - 2002 - 00372 ‘ Diabetes Prevention ’ . Other funding came from the EFSD/JDRF/Novo Nordisk Focused Research Grant , Academy of Finl and , Dutch Diabetes Research Foundation and Finnish Diabetes Research Foundation )
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 .