Infants with genetic risk factors for celiac disease who avoided cow’s milk-based formula were just as likely to develop the disease later in life as those who did not, according to the results of a Finnish randomized controlled trial.
However, the investigators noted that infants who consumed cow’s milk-based formula had increased titers of cow’s milk antibodies before they developed celiac disease or antibodies to tissue transglutaminase (anti-TG2A), suggesting those who develop the disease may have increased intestinal permeability early in life.
“Avoiding cow’s milk based formula in children with HLA-conferred risk for type 1 diabetes reduced the cumulative incidence of diabetes-associated autoantibodies by the age of 10 years in the TRIGR pilot study,” investigators wrote. “We set out to study in that same population whether weaning to an extensively hydrolyzed formula would decrease the risk of celiac disease autoimmunity and/or celiac disease as well. We also assessed whether increased cow’s milk antibody concentrations are associated with subsequent celiac disease autoimmunity and/or celiac disease.”
For the double blind trial, the investigators recruited 230 infants (57% boys) who were genetically predisposed to type 1 diabetes and had a first-degree relative with the disease from 15 hospitals in Finland between February 1995 and November 1997. They randomly assigned 113 infants to a casein hydrolysate formula and 117 to conventional formula during the first 6 to 8 months of life whenever breastmilk was not available. Then they analyzed serum samples for cow’s milk antibodies during the first 2 years, and for celiac antibodies over a median of 10 years. They also took duodenal biopsies if they measured antibodies to tissue transglutaminase (anti-TG2A) levels higher than 20 relative units.
“Breastfeeding was encouraged and exceeded national averages in both study groups,” the researchers noted. “Parents were told not to feed the children any commercial baby foods and other foods containing bovine protein during the intervention period. Adherence to the protocol was monitored by means of regular family interviews and by analysis of cow’s milk antibodies in serum samples.”
Ten (4.3%) of the total cohort developed celiac disease, and 13.2% of the 189 infants analyzed for anti-TG2A tested positive. The investigators found no significant differences in the cumulative incidence of celiac disease (HR = 4.13; 95% CI, 0.81-21.02) or anti-TG2A positivity (HR = 1.14; 95% CI, 0.51-2.54) between groups.
They noted that duration of breastfeeding and age that cereals were introduced were comparable between individuals with and without celiac disease or anti-TG2A positivity.
Further, they wrote that infants who developed celiac disease had higher cow’s milk antibody titers before they developed celiac autoimmunity or celiac disease, which could be explained by the presence of abnormal gut permeability even before exposure to gluten. Additional research on the link between early exposure to cow’s milk and the development of celiac disease is therefore warranted, they added.
“The current results indicate that weaning to an extensively hydrolyzed formula does not decrease the risk of celiac disease autoimmunity or celiac disease,” they concluded. – by Adam Leitenberger
Disclosures: The researchers report no relevant financial disclosures.