The MARTHA study is part of the consortium “A World Without Asthma” (AWWA). This broad research cooperation was initiated by the Dutch patient organisation “Lung Foundation – LongFonds”. The foundation is seeking basic fundamental solutions to help patients suffering from asthma and other lung diseases. For this cause LONGFONDS | Accelerate brought together well-recognised scientists, physicians and patients. Together, they are all working hard towards one goal: A rapid medical breakthrough in asthma research, so that new found methods can be used to prevent asthma and lung diseases from developing in the first place. The MARTHA study as part of AWWA aims to show that the prevention of asthma is possible with a gently processed cow’s milk.
The children of farmers’ studies have consistently shown that children who regularly drink raw milk gain protection against asthma, allergies and respiratory infections. The MARTHA study is now aimed to test these findings by comparing the health status of young children who drink a given amount of two different types of milk every day (conventional or the study milk).
All participating children are asked to drink 200 ml of milk on a daily basis at the earliest from the 7th month of life, and when they are no longer fully breast-fed. Later on they are asked to drink 150 ml of milk twice a day from the 10th month of life. One group of children receives the MARTHA study gently processed milk (study milk), the other group receives a normal commercially available ultra-high-temperature treated (UTH) milk (comparison milk). The assignment to either group is randomly done by chance. Both types of milk come from Bavarian cows. The test milk is a certified organic hay milk, and the comparison milk is sourced from Bavarian farms that all have committed themselves to sustainable and animal-friendly farming. They both renounce the use of neonicotinoids and herbicides such as glyphosate. Their cows are only fed GMO-free on the surrounding grazing grounds.
No child is at a disadvantage if he or she is randomly assigned to one of the two groups. Giving the comparison milk is equivalent to giving conventional off the shelf milk, so called H-/ UHT or ESL milk in Germany.
Feeding the milk as part of the intervention phase is continued until the child is three years old. During the intervention phase, the parents are asked to answer weekly online questionnaires via email enquiring whether the child tolerated the milk, had colds or similar illnesses and which additional foods the child received. Every four weeks, additional questions are asked about the child’s living environment (e.g. day care visits or animal contacts). After the end of the intervention phase, participants are solely followed-up with a online questionnaire to observe whether the child has developed asthma or not. These online questionnaires are to be completed every three months and are aimed to primarily collect data on the child’s health status.
The children are invited to three visits to the study outpatient clinic. The first visit takes place before the child can be included into the study, at the earliest at the age of six months and is a requirement to check for eligibility, give out all relevant information, ask for consent by the legal guardians, record previous illnesses, conduct a physical examination, collect blood and other samples (see below) as well as the allocate the child to one of the two experimental groups by lot. The second visit takes place at the age of two years and aims to record the emergence of possible conditions such as neurodermatitis (atopic eczema) and general disease precursors (atopic sensitisation, inflammation values). Bio samples are taken again for this purpose.
In autumn and winter 2021/2022, all children that are already participating will be invited to the second clinical visit, even if they are not yet two years old. This is also intended to record all early childhood infections that are predicted to occur more frequently now after the hygiene measures of the COVID19 pandemic will be ceased.
The third and final visit to the study outpatient clinic takes place after the completion of the intervention phase at the age of three years. The same examinations are carried out as have been done at the second clinical visit.
During all three visits to the outpatient clinic, small amounts of blood are taken. The blood is used for an allergy test and to determine the inflammation level. In addition, the blood and nasal mucosa cell samples are used to investigate which genes are switched on to understand how the milk’s protective properties work on a fundamental level. Nasal swabs and stool samples are used to examine bacteria that normally colonise the body the so called microbiome. This microbiome is thought to be favourably affected by the milk. There is evidence that milk works particularly well in children who have certain hereditary set-up or low fatty acid levels. Therefore, said genes are examined in the blood and fatty acid levels are measured. At the second and third visit, mucosal cells are also collected from the nose with a small brush for testing immune reaction and gene expression. Nasal secretions are also collected for inflammatory markers using very small tissue strips.
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.
Aim of the study
Through the MARTHA study, we are testing whether the newly developed test milk can actually prevent the development of asthma and allergies in children.
To do this, we are comparing cow milk that has been gently processed using the new method with conventionally processed milk (reference milk).
If there is a difference in frequency of asthma and allergy cases, then it will be very easy to prevent the development of asthma in children in the future by administering the test milk.
The study procedure
A total of 956 children are included in the study after birth from Munich and surrounding regions. All children are divided into two groups and receive either the study or the normal comparison milk with a shelf life of about one week. As a rule, the administration of the study milk already covers the entire requirement of milk for younger children. The recommendation for infant and toddler nutrition of the German Society for Paediatrics and Adolescent Medicine is available for reference.
We collect information on the living environment of the participating families, on the family history of allergies and asthma, on nutrition and on the health of the children through online questionnaires on a regular basis.
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 main funding for setting up the MARTHA study comes from LONGFONDS I Accelerate. This is an international research program in which renowned scientists, physicians, lung patients and social partners work closely together to achieve a common goal: to accelerate medical breakthroughs in asthma research.
To this end, an international consortium focusing on asthma prevention has been formed under the leadership of the Dutch Lung Foundation. The MARTHA study is part of this consortium "A World Without Asthma (AWWA)". Funding comes from private donors, bequests and other capital resources.
How can you participate?
All interested families whose child will be born after the first of January 2018 and who are willing to feed their child the study milk as well as to come personally to the study outpatient clinic in Munich 3 times during the study period.
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 email@example.com or call us under +4989440057930.