Milk Against Respiratory Tract Infections and Asthma
Organizational Data
- DRKS-ID:
- DRKS00014781
- Recruitment Status:
- Recruiting complete, study continuing
- Date of registration in DRKS:
- 2018-10-01
- Last update in DRKS:
- 2023-11-29
- Registration type:
- Prospective
Acronym/abbreviation of the study
MARTHA
URL of the study
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.
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. The milks are indistinguishable by appearance and packaging. 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 quarter 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 is performed during intervention and the third marks the end of the intervention phase at age 3 years. During these visits children undergo clinical examination (biosamples will be collected again) and the secondary outcomes such as atopic eczema will be assessed. The primary outcome atopic sensitization will be assessed at the third and final visit.
Health condition or problem studied
- ICD10:
- J45 - Asthma
- ICD10:
- J06 - Acute upper respiratory infections of multiple and unspecified sites
- ICD10:
- T78.4 - Allergy, unspecified
- Healthy volunteers:
- Yes
Interventions, Observational Groups
- Arm 1:
- Test milk; mildly pasteurized, not further processed cow's milk; from 6 to 9 months: daily 200ml milk; from 10 to 35 months: twice daily 150ml milk
- Arm 2:
- Regularly processed cow's milk; from 6 to 9 months: daily 200ml milk; from 10 to 35 months: twice daily 150ml milk
Endpoints
- Primary outcome:
- Atopic sensitization at age 3 years
- Secondary outcome:
- Physician diagnosis of asthma until age 5; 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; Levels of high-sensitivity C-reactive protein in serum at age 3 years
Study Design
- Purpose:
- Prevention
- Allocation:
- Randomized controlled study
- Control:
-
- Placebo
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
-
- Assessor
- Data analyst
- Investigator/therapist
- Patient/subject
Recruitment
- Recruitment Status:
- Recruiting complete, study continuing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center Dr. von Haunersches Kinderspital München
- University medical center Krankenhaus Barmherzige Brüder Regensburg - Klinik St. Hedwig Regensburg
Recruitment period and number of participants
- Planned study start date:
- 2018-10-01
- Actual study start date:
- 2018-11-07
- Planned study completion date:
- 2025-12-31
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 960
- Final Sample Size:
- 260
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 6 Months
- Maximum Age:
- 12 Months
- Additional Inclusion Criteria:
- Healthy, term-born (35 gestational weeks) infants of both sexes; 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
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; Uncertainty of the study physician about prospective adherence to study protocol, e.g. known or persistent abuse of medication, drugs or alcohol in caregivers; A sibling already enrolled
Addresses
Primary Sponsor
- Address:
- Klinikum der Universität München - Dr. von Haunersches KinderspitalProf. Dr. Dr.h.c. Erika von MutiusLindwurmstraße 480337 MünchenGermany
- Telephone:
- +49 (0)89 4400 57897
- Fax:
- +49 (0)89 4400 54452
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.klinikum.uni-muenchen.de/Kinderklinik-und-Kinderpoliklinik-im-Dr-von-Haunerschen-Kinderspital/de/index.html
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Klinikum der Universität München - Dr. von Haunersches KinderspitalProf.Dr. Dr.h.c. Erika von MutiusLindwurmstraße 480337 MünchenGermany
- Telephone:
- +49 (0)89 4400 57897
- Fax:
- +49 (0)89 4400 54452
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.klinikum.uni-muenchen.de/Kinderklinik-und-Kinderpoliklinik-im-Dr-von-Haunerschen-Kinderspital/de/index.html
Contact for Public Queries
- Address:
- Klinikum der Universität München - Dr. von Haunersches Kinderspital - Studiensekretariat MARTHA StudieMaistraße 11 (Frauenklinik)80337 MünchenGermany
- Telephone:
- 089 4400 57930
- Fax:
- 089 4400 54452
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.klinikum.uni-muenchen.de/Kinderklinik-und-Kinderpoliklinik-im-Dr-von-Haunerschen-Kinderspital/de/index.html
Principal Investigator
- Address:
- Klinikum der Universität München - Dr. von Haunersches KinderspitalProf.Dr. Dr.h.c. Erika von MutiusLindwurmstraße 480337 MünchenGermany
- Telephone:
- +49 (0)89 4400 57897
- Fax:
- +49 (0)89 4400 54452
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.klinikum.uni-muenchen.de/Kinderklinik-und-Kinderpoliklinik-im-Dr-von-Haunerschen-Kinderspital/de/index.html
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- FrieslandCampinaStationsplein 43818 LE AmersfoortNetherlands
- Telephone:
- No Entry
- Fax:
- +31 (0)33 7133333
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Private sponsorship (foundations, study societies, etc.)
- Address:
- Longfonds StichtingStationsplein1273818 LE AmersfoortNetherlands
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Med. Fakultät der LMUPettenkoferstraße 880336 MünchenGermany
- Telephone:
- +49-89-440055191
- Fax:
- +49-89-440055192
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2018-05-30
- Ethics committee number:
- 18-405
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2018-08-06
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- Statistical Analysis Plan (a signed version is stored locally)
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry