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Prevention of allergies and infections by minimally processed milk in infants - the MARTHA feasibility and safety trial
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  • Melanie Weber,
  • Franziska Hehn,
  • Yvi Huynh,
  • Aaron Remkes,
  • Christine Strunz-Lehner,
  • Irmgard Häuser,
  • Stefanie Hollunder,
  • Sheena Sharma,
  • Sibylle Contento,
  • Ulrich Mansmann,
  • Erika von Mutius,
  • Markus Johannes Ege
Melanie Weber
LMU Klinikum Kinderklinik und Kinderpoliklinik im Dr von Haunerschen Kinderspital
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Franziska Hehn
LMU Klinikum Kinderklinik und Kinderpoliklinik im Dr von Haunerschen Kinderspital
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Yvi Huynh
LMU Klinikum Kinderklinik und Kinderpoliklinik im Dr von Haunerschen Kinderspital
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Aaron Remkes
LMU Klinikum Kinderklinik und Kinderpoliklinik im Dr von Haunerschen Kinderspital
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Christine Strunz-Lehner
LMU Klinikum Kinderklinik und Kinderpoliklinik im Dr von Haunerschen Kinderspital
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Irmgard Häuser
LMU Klinikum Kinderklinik und Kinderpoliklinik im Dr von Haunerschen Kinderspital
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Stefanie Hollunder
LMU Klinikum Kinderklinik und Kinderpoliklinik im Dr von Haunerschen Kinderspital
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Sheena Sharma
LMU Klinikum Kinderklinik und Kinderpoliklinik im Dr von Haunerschen Kinderspital
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Sibylle Contento
LMU Klinikum Kinderklinik und Kinderpoliklinik im Dr von Haunerschen Kinderspital
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Ulrich Mansmann
Ludwig-Maximilians-Universitat Munchen Institut fur medizinische Informationsverarbeitung Biometrie und Epidemiologie
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Erika von Mutius
LMU Klinikum Kinderklinik und Kinderpoliklinik im Dr von Haunerschen Kinderspital
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Markus Johannes Ege
LMU Klinikum Kinderklinik und Kinderpoliklinik im Dr von Haunerschen Kinderspital

Corresponding Author:markus.ege@med.lmu.de

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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.
Submitted to Pediatric Allergy and Immunology
Submission Checks Completed
Assigned to Editor
Reviewer(s) Assigned
22 Jun 2024Review(s) Completed, Editorial Evaluation Pending
25 Jun 2024Reviewer(s) Assigned
19 Jul 2024Editorial Decision: Revise Major
25 Aug 20241st Revision Received
26 Aug 2024Submission Checks Completed
26 Aug 2024Assigned to Editor
26 Aug 2024Review(s) Completed, Editorial Evaluation Pending
29 Aug 2024Reviewer(s) Assigned
20 Sep 2024Editorial Decision: Accept