Background of the MARTHA study
Asthma and other allergic conditions such as hay fever or atopic dermatitis have been on the rise in Germany and other western countries for years now. Many children and adolescents are affected and their quality of life is sometimes considerably compromised. To date, there is no effective way to prevent the emergence of those conditions, which are mostly chronic in nature. This is why several research groups around the world have been investigating the causes of these conditions as well as researched ways to prevent them.
Pursueing this objective we discovered in our "Farm Children Studies" a much lower occurrence of asthma and allergies in children growing up on farms. We found out that one of the protective factors for asthma was raw milk obtained directly from a dairy farm. That is how the idea arose to test raw milk in an intervention study as a potential preventive for asthma and allergies.
As raw milk can be potentially contaminated with dangerous bacteria, it cannot be recommended for consumption as a potential preventive for infants. Therefore we have asked a dairy cooperative to develop a new and gentler process to preserve the favourable properties of raw milk whilst killing all germs that are dangerous to health. Now we would like to research if such a gently processed milk can successfully prevent and counteract the development of asthma and allergies in children. We therefore want to test whether this newly developed milk actually protects from asthma and allergies.
For that reason we would like to ask you for your support of the MARTHA study.
Who can participate in the study?
All interested families are welcome to participate if their child is born after the 01.10.2018. Participation is open to families who are willing to give the study milk to their child and who are willing to come to all three outpatient appointments during the course of the study in either Munich or Regensburg.
How does the study run in detail?
After breastfeading, most children receive either an infant formula or cow's milk as sold in supermarkets (ultra-high temperature or extended shelf-life milk). If your child participates in our MARTHA study, we will supply you with the study milk free of charge. Random selection will decide if your child will receive the new test milk or regular milk as it can be bought in supermarkets. You will only have to devote little time, as we will invite you to only three outpatient appoinments during the course of the study of 4 1/2 years. Each appointment will last for about an hour. Additionally, you will be receiving information and weekly questionnaires by email. The questionnaires will take on average about 10 minutes. Of course, we shall reimburse your travel expenses.
In detail the procedure of the study would lookas follows for you and your child:
- Children will be included in the study if they are at least six months old and are no longer exclusively breastfed.
- Participating children will be randomly divided into two study groups: In one group the newly developed study milk will be given, in the other group conventionally processed milk will be given.
- All participating children drink and age-adjusted amount of the study milk on a daily basis. Other milk (as well as breast milk) and ohter foods (baby food jars, pureed nutrition, vegetables and fruits) can be given without any restrictions.
- In early childhooh most children like to drink milk. The study milk should be given to the children for 2 1/2 years. The milk will be shipped to the participating families free of charge.
- The parents will be asked to answer weekly questionnaires through a safe internet connection about the health and diet of the study child. A more extense questionnaire will be completed by families four times a year.
- We invite all MARTHA children to visit our study outpatient clinic when they are 6 months, 3 years and 5 years of age. During these visits our study physicians will collect blood samples from a vein or the tip of the finger, as well as nose and inner cheek swabs, and finally, a stool sample. The parents will fill out questionnaire in the meantime.
What are the advantages of participation?
- You will receive the study milk free of charge.
- Your child will receive additional health check-ups and the results of the allergy test will be sent to you.
- You can use the weekly phone consultation with our study physicians free of charge.
- With your participation you are invaluably contributing to the prevention of asthma and allergies in future generations.
- You will receive a health diary containing all your weekly entries after the study has terminated.
What are the disadvantages of participating?
Generally, the participation in the MARTHA study requires some time: Each of the three outpatient visits lasts for approximately 1 hour and filling out the weekly questionnaire takes 2 to 5 minutes. Every four weeks the completion of the questionnaire will take about 10 minutes and four times a year about 30 minutes. There are no health risks associated with participating in this study.
How is your data handled?
All personal information you share with us will be encrypted and handled confidentially according to the Data Protection Regulations.
Who is funding the MARTHA study?
The MARTHA study is funded by donations raised by “Dutch Longfonds”. This is a patients’ organisation caring for people affected by asthma or other lung diseases and engaged in promoting a world without asthma. The milk powder will be supplied free of charge from a dairy cooperative.
How can you participate?
Today we ask you for your contact details. In a few months we will then invite you to the first outpatient appointment. During this appointment your study doctor will explain the study in detail and ask you for your written consent on your child’s participation in the study. If you are intersted, please contact us under firstname.lastname@example.org or call us either under +4989440057930 for Munich or +4994136995015 for Regensburg.