Minimally processed cow’s milk and early childhood asthma-related outcomes: exploratory findings from the early terminated MARTHA randomized trial
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Background
Raw milk consumption has repeatedly been shown to be inversely related to asthma, respiratory infections, and allergies but carries a potential risk of life-threatening infections. The MARTHA trial (DRKS00014781) used minimally-processed pasteurized milk as a microbiologically safe proxy for raw milk and compared it against ultra-heat-treated milk for efficacy on atopic sensitization, asthma, and respiratory infections.
Methods
Healthy children were recruited through birth clinics in Germany. At 6 to 12 months, they were centrally randomized to obtain minimally-processed full-cream versus ultra-heat-treated semi-skimmed cow’s milk daily until age 3 years. During the SARS-CoV-2 pandemic, recruitment was stopped, and the study was continued without confirmatory intention. The primary endpoint was shifted from asthma as composite parent-reported diagnosis of asthma or recurrent obstructive bronchitis until age 5 to atopic sensitization at age 3 years. Participants, caregivers, and study staff were blinded to group assignments.
Results
We randomized 130 individuals into each study arm. The intervention was unrelated to atopic sensitization (risk ratio, RR=1.13 [0.67-1.89]), which occurred in 28 individuals of the intervention (n=99) and 24 of the comparator group (n=96). Asthma showed a trend for an inverse association (hazards ratio, HR=0.55 [0.27−1.16], n=252), which was pronounced in the 82 children with a family history of asthma (post-hoc HR=0.30 [0.09−0.93]). The intervention was inversely associated with rhinitis and cough in the older half of the children (post-hoc RR=0.82 [0.67-0.998] and RR=0.75 [0.60-0.94], respectively). No adverse events were judged intervention-related.
Interpretation
The intervention did not reduce atopic sensitization at age 3 years. Exploratory analyses suggested possible protective effects on asthma and respiratory symptoms, particularly in children with parental asthma and in those less affected by pandemic-related disruptions. These findings justify but do not replace a definitive trial.
Funding
Dutch Longfonds; Bavarian State-Ministry of Health, Care and Prevention; German Center for Lung Research (DZL); FrieslandCampina.
