Minimally processed cow's milk and early childhood asthma-related outcomes: exploratory findings from the early terminated MARTHA randomized trial

@misc{weber2026minimally,
  title = {{Minimally processed cow's milk and early childhood asthma-related outcomes: exploratory findings from the early terminated MARTHA randomized trial}},
  author = {M. Weber and Y. Huynh and G. Pagani and M. Depner and S. Gschwendtner and H. Demmelmair and C. Skevaki and H. H. Smits and K. Hettinga and M. Schloter and C. Strunz-Lehner and J. Heinrich and E. von Mutius and M. J. Ege},
  howpublished = {medRxiv},
  year = {2026},
  month = oct,
  doi = {10.64898/2026.10.23.26363903},
  url = {https://www.medrxiv.org/content/10.64898/2026.10.23.26363903v1},
  note = {CC BY-NC-ND},
}

TY  - UNPB
TI  - Minimally processed cow's milk and early childhood asthma-related outcomes: exploratory findings from the early terminated MARTHA randomized trial
AU  - M. Weber
AU  - Y. Huynh
AU  - G. Pagani
AU  - M. Depner
AU  - S. Gschwendtner
AU  - H. Demmelmair
AU  - C. Skevaki
AU  - H. H. Smits
AU  - K. Hettinga
AU  - M. Schloter
AU  - C. Strunz-Lehner
AU  - J. Heinrich
AU  - E. von Mutius
AU  - M. J. Ege
PY  - 2026
DA  - 2026/10/23
PB  - medRxiv
DO  - 10.64898/2026.10.23.26363903
UR  - https://www.medrxiv.org/content/10.64898/2026.10.23.26363903v1
AB  - BackgroundRaw 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.  MethodsHealthy 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 cows 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.  ResultsWe 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.  InterpretationThe 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.  FundingDutch Longfonds; Bavarian State-Ministry of Health, Care and Prevention; German Center for Lung Research (DZL); FrieslandCampina.
ER  -