Trial document




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  DRKS00014781

Trial Description

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Title

Milk Against Respiratory Tract Infections and Asthma

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Trial Acronym

MARTHA

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Frequency of asthma and allergic diseases, e.g. hayfever or atopic eczema, have increased in Germany throughout the past years. Several studies identified protective factors on farms that prevent from asthma and allergies, e.g. raw milk. With the MARTHA study we aim to test if a mildly pasteurized milk is able to prevent development of respiratory infections, asthma and allergies in children. Therefore, we compare the mildly pasteurized milk with regularly treated milk. All children who are at least 6 months old can participate. Participants will be randomized and allocated to a study arm by chance. One group receives the mildly pasteurized milk, the other group the regularly treated milk. All study participants consume one bottle (glass, mug) of their test milk daily until the age of 3 years.

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Brief Summary in Scientific Language

Studies examining farm children and farm milk consumption have consistently shown inverse associations between consumption of farm milk and asthma, allergies and respiratory infections leading to the hypothesis that unprocessed cow's milk protects from these conditions. The MARTHA study tests this hypothesis in a randomized controlled trial in infants. Between 6 and 12 months infants start after weaning with drinking daily 200ml milk. From the age of 10 months on infants receive twice daily 150ml milk. One group receives minimally processed milk. This minimally processed milk has been processed only to prevent transmission of germs and diseases according to legal requirements for pasteurized milk. For comparison the other group receives semi-skimmed, ultra-heat treated (UHT) milk as it is used in follow-on formula. Both investigational milk products will be provided as mildly dried powders. Both milk powders are indistinguishable by appearance and taste. Neither the investigators nor the family will be informed to which study arm the infant is allocated until the end of the study.
Administration of the milk continues until the age of 3 years. The milk-intervention period is followed by an observational period of 2 years, until the age of 5 years. During the 2½ years of intervention period parents will answer a weekly web-based diary with questions on how well the milk was tolerated, whether respiratory tract infections or other relevant medical conditions occurred, and on consumption of supplemental solid foods. Every 4 weeks additional questions regarding living environment including day care visits and animal exposure will be asked.
Children will participate at a total of 3 clinical visits. At 6 months of age, infants undergo a clinical examination (capillary blood sampling (300µl) and other samples including nasal and buccal swabs) and are enrolled according to inclusion and exclusion criteria as well as randomized to treatment arms. The second visit marks the end of the intervention phase at age 3 years. During this visit children undergo another clinical examination (biosamples will be collected again) and secondary outcomes such as atopic eczema, atopic sensitization, and low-grade inflammation as determined by high-sensitivity C-reactive protein will be assessed. The third visit occurs at the end of the observation period at the age of 5 years and determines the primary outcome asthma until age 5 years.

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Organizational Data

  •   DRKS00014781
  •   2018/10/01
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  •   yes
  •   Approved
  •   18-405, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

  •   U1111-1216-7580 
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Health Condition or Problem studied

  •   J45 -  Asthma
  •   J06 -  Acute upper respiratory infections of multiple and unspecified sites
  •   T78.4 -  Allergy, unspecified
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Interventions/Observational Groups

  •   Test milk; mildly pasteurized, not further processed; milk powder; from 6 to 9 months: daily 200ml formula milk; from 10 to 35 months: twice daily 150ml formula milk
  •   Regularly processed milk; milk powder; from 6 to 9 months: daily 200ml formula milk; from 10 to 35 months: twice daily 150ml formula milk
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, assessor, data analyst
  •   Placebo
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Physician diagnosis of asthma until age 5

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Secondary Outcome

Atopic sensitization at age 3 years and at age 5 years; Rhinitis irrespective of cough and wheeze until age 3 years; Respiratory tract infections without wheeze until age 3 years; Otitis media until age 3 years; Atopic eczema at age 3 years and 5 years; Levels of high-sensitivity C-reactive protein in serum at age 3 years and 5 years

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/11/07
  •   3214
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   6   Months
  •   1   Years
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Additional Inclusion Criteria

Healthy, term-born infants of both sexes; Singleton pregnancy; Age 6 to 12 months at randomization; Caregivers with the ability to follow study instructions and likely to attend and complete all required visits; Caregivers have a mobile phone or a personal computer and are likely to keep a web-based diary regularly; Written informed consent of the parents or guardians

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Exclusion Criteria

Suspected or confirmed cow’s milk allergy, milk intolerance, lactose intolerance, suspected immunodeficiency, cystic fibrosis, failure to thrive; Simultaneous participation in another intervention study; Maternal age below 18 years; Refusal of blood sampling at 6 months; Uncertainty of the study physician about prospective adherence to study protocol, e.g. known or persistent abuse of medication, drugs or alcohol in caregivers

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Addresses

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Sources of Monetary or Material Support

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    • Longfonds Stichting
    • Stationsplein127
    • 3818  LE Amersfoort
    • Netherlands
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    • FrieslandCampina
    • Stationsplein 4
    • 3818 LE  Amersfoort
    • Netherlands
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    •   +31 (0)33 7133333
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.