Purpose HELMi (Health and Early Life Microbiota) is a longitudinal, prospective general population birth cohort, set up to identify environmental, lifestyle and genetic factors that modify the intestinal microbiota development in the first years of life and their relation to child health and well-being.
Participants The HELMi cohort consists of 1055 healthy term infants born in 2016–2018 mainly at the capital region of Finland and their parents. The intestinal microbiota development of the infants is characterised based on nine, strategically selected, faecal samples and connected to extensive online questionnaire-collected metadata at weekly to monthly intervals focusing on the diet, other exposures and family’s lifestyle as well as the health and growth of the child. Motor and cognitive developmental screening takes place at 18 months. Infant’s DNA sample, mother’s breast milk sample and both parent’s spot faecal samples have been collected.
Findings to date The mean age of the mothers was 32.8 (SD 4.1) and fathers/coparents 34.8 (5.3) years at the time of enrolment. Seventeen percentage (n=180) of the infants were born by caesarean section. Just under half (49%) were firstborns; 50.7% were males. At 3 months of age, 86% of the babies were exclusively breastfed and 2% exclusively formula-fed.
Future plans The current follow-up from pregnancy to first 24 months will be completed in March 2020, totalling to over 10 000 biological samples and over 50 000 questionnaire entries. The results are expected to identify environmental and host factors that affect early gut microbiota development and health, and hence give indications of how to prevent or reverse microbiota perturbations in infancy. This prospective cohort will be followed up further to identify how the early microbiota relates to later health outcomes, especially weight gain, infections and allergic and other chronic diseases.
Trial registration number NCT03996304; Pre-results.
- birth cohort
- intestinal microbiota development
- early life exposures
- longitudinal follow-up
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ED and EH contributed equally.
Contributors WdV, AS, K-LK and KK designed and established the cohort. AS and KK designed the online questionnaires and their interactive features. K-LK participated in the design of the questionnaires and acts as a responsible study doctor. AS and ED are responsible for the continued management of the cohort and KK for the data management. ED collects and archives the samples and EH and AS are responsible for project’s social media for recruitment, communication and dissemination purposes. ED, EH, AS and KK analysed the results and AS, EH and KL-K interpreted them. EH, AS and ED drafted and edited the manuscript. WMdV and K-LK revised major contents. All authors critically reviewed and approved the final manuscript.
Funding The establishment of the HELMi cohort and the required infrastructure for data collection was conducted with the support of Tekes, the Finnish Funding agency for Technology and Innovation (currently Business Finland), grant 329/31/2015 to WMdV and AS, under the medical supervision of KLK. The grant involves cofunding from three companies: Valio Ltd, Dupont Nutrition and Health and Oriola, and in-kind support from the with the Finnish Red Cross Blood service in FUT2 genotyping. The daily sampling within HELMiPlus subproject has been supported by the Academy of Finland grant 1297765 to KK. Academy of Finland grant 1308255 to WMdV supports the analysis of dust microbiota and integration of the data with all of the major Finnish population based birth cohorts. Academy of Finland grant 325103 to AS supports the organization of 4-year follow-up of the cohort. Personal grant by Paulo Foundation, and project grants by Päivikki ja Sakari Sohlberg Foundation and Biocodex Microbiota Foundation have been granted to AS. AS has received H2020-MSCA-ITN-2018 grant 8144102 and the Foundation for Nutrition Research grant to support two PhD projects. Specific microbiota analysis has been and will be supported by the unrestricted Spinoza award of the Netherlands Organization for Scientific Research to WMdV.
Competing interests All authors declare support from Valio Ltd, Finnish Red Cross Blood Service, Dupont Nutrition and Health and Oriola Ltd in the form of a grant that has partially funded the study.
Ethics approval The study was approved by the ethical committee of The Hospital District of Helsinki and Uusimaa (263/13/03/03 2015) and performed in accordance with the principles of the Helsinki Declaration.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement All microbiota data will me made publicly available upon publication of the results in scientific articles. Due to legislative and ethical reasons, questionnaire and registry data cannot be made freely accessible even in de-identified form without an application process that includes submission of a research plan that will first undergo evaluation by the HELMi scientific board and then by relevant research ethics committees.
Collaborators We currently collaborate with Professor Katri Räikkönen and Adjunct professor Kati Heinonen (psychology; cognitive and developmental testing) from the University of Helsinki, Professor Marco Ventura (bifidobacterial analysis, bacterial genomics) from the University of Parma, Italy and Maijaliisa Erkkola from the University of Helsinki (nutritional sciences; dietary intake and nutritional assessment). Dr Pirkka Kirjavainen from the Environmental Health Unit, National Institute for Health and Welfare, Kuopio, Finland, will be responsible for coordinating the house dust analysis. Researchers interested in collaboration are invited to propose human genetics, immunological or epidemiological research based on the data available from the HELMi cohort or submit a suggestion for additional data collection. Requests should be sent to AS (email@example.com) and will be reviewed by the HELMi scientific board.
Patient consent for publication Obtained.
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