Prevention of allergies and infections by minimally processed milk in
infants - the MARTHA feasibility and safety trial
Abstract
Background Consumption of raw cow’s milk has repeatedly been
shown to protect from asthma, allergies, and respiratory infections. As
raw milk bears potential health hazards, it cannot be recommended for
prevention. Therefore, we performed an intervention study with
microbially safe but otherwise minimally processed cow’s milk. Here we
describe feasibility and safety of the trial. Methods The
MARTHA trial (DRKS00014781) was set up as a double-blind randomized
intervention in a population residing in Bavaria. Infants from 6 to 36
months of age consumed minimally processed cow’s milk (intervention arm)
or ultra-heat-treated (UHT) semi-skimmed milk (comparator arm).
Results At the age of 6 to 12 months, 260 infants were
enrolled, with 72% having a family history of atopy. The extensive
screening system for milk consumption and symptoms suggestive of adverse
events was well accepted with 22,988 completed weekly surveys and an
average completion of 82% surveys sent out. The children consumed the
study milk on average on 457 days (61% of intervention days). The
intervention proved to be safe without any case of milk allergy or milk
intolerance under the intervention in both arms. All 6 cases of serious
adverse events were unrelated to milk. The most common reason was
unscheduled hospitalization of more than 3 days. Conclusions
The intervention with minimally processed milk and the study instruments
proved feasible. During the age of 6 to 36 months, there was no
increased risk of milk allergy in a population with a substantial
proportion of family history of atopy.