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BMJ Open Is Committed to Open Peer Review. As Part of This Commitment We Make the Peer Review History of Every Article We Publish Publicly Available BMJ Open: first published as 10.1136/bmjopen-2018-022013 on 21 October 2018. Downloaded from BMJ Open is committed to open peer review. As part of this commitment we make the peer review history of every article we publish publicly available. When an article is published we post the peer reviewers’ comments and the authors’ responses online. We also post the versions of the paper that were used during peer review. These are the versions that the peer review comments apply to. The versions of the paper that follow are the versions that were submitted during the peer review process. They are not the versions of record or the final published versions. They should not be cited or distributed as the published version of this manuscript. BMJ Open is an open access journal and the full, final, typeset and author-corrected version of record of the manuscript is available on our site with no access controls, subscription charges or pay-per-view fees (http://bmjopen.bmj.com). If you have any questions on BMJ Open’s open peer review process please email [email protected] http://bmjopen.bmj.com/ on September 28, 2021 by guest. Protected copyright. BMJ Open BMJ Open: first published as 10.1136/bmjopen-2018-022013 on 21 October 2018. Downloaded from Study protocol: “Nutritional impact on Immunological maturation during Childhood in relation to the Environment (NICE)”, a prospective birth-cohort in northern Sweden ForJournal: peerBMJ Open review only Manuscript ID bmjopen-2018-022013 Article Type: Protocol Date Submitted by the Author: 29-Jan-2018 Complete List of Authors: Barman, Malin; Chalmers University of Technology, Department of Biology and Biological Engineering; Sahlgrenska universitetssjukhuset, Department of Obstetrics and Gynecology Murray, Fiona; Region Norrbotten, Sunderby Research Unit Bernardi, Angelina; University of Gothenburg, Institute of Biomedicin, Department of Infectious Diseases Broberg, Karin; Karolinska Institutet, Institute of Environmental Medicine Bölte, Sven; Karolinska Institutet, Department of Women’s and Children’s Health Hesselmar, Bill; University of Gothenburg, Institute of Clinical Sciences, Department of Paediatrics Jacobsson, Bo; University of Gothenburg, Institute of Clinical Sciences, Department of Obstetrics and Gynecology Jonsson, Karin; Chalmers University of Technology, Department of Biology http://bmjopen.bmj.com/ and Biological Engineering Kippler, Maria; Karolinska Institutet, Institute of Environmental Medicine Rabe, Hardis; Gothenburg University, Institute of Biomedicine, Department of Infectious Diseases Ross, Alastair; Chalmers University of Technology, Department of Biology and Biological Engineering Sjöberg, Fei; University of Gothenburg, Institute of Biomedicine, Department of Infectious Diseases Strömberg, Nicklas; Umeå University, Department of Odontology/Cariology on September 28, 2021 by guest. Protected copyright. Vahter, Marie; Karolinska Institutet, Institute of Environmental Medicine Wold, Agnes; University of Gothenburg, Institute of Biomedicine, Department of Infectious Diseases Sandberg, Ann-Sofie; Chalmers University of Technology, Department of Biology and Biological Engineering Sandin, Anna; Umeå University, Department of Clinical Sciences birth cohort, Allergy < THORACIC MEDICINE, Nutrition < TROPICAL Keywords: MEDICINE, Microbiology < PATHOLOGY, toxicants, Immunology < BASIC SCIENCES For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 28 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2018-022013 on 21 October 2018. Downloaded from 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 For peer review only 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 http://bmjopen.bmj.com/ 34 35 36 37 38 39 40 41 on September 28, 2021 by guest. Protected copyright. 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 2 of 28 BMJ Open: first published as 10.1136/bmjopen-2018-022013 on 21 October 2018. Downloaded from 1 2 3 1 Study protocol: “Nutritional impact on Immunological maturation 4 2 5 during Childhood in relation to the Environment (NICE)”, a 6 3 prospective birth-cohort in northern Sweden 7 4 8 5 Barman, M.1+2, Murray, F.3, Bernardi, AI.4, Broberg, K.5, Bölte, S.,6 Hesselmar, B.7, 9 6 Jacobsson, B.8, Jonsson, K.1, Kippler, M.5, Rabe, H.4 Ross, A.1, Sjöberg, F.4, Strömberg, N.9, 10 5 4 1 3+10 11 7 Vahter, M. , Wold, A. E. , Sandberg, A-S. , and Sandin, A. 12 8 1 13 9 Food and Nutrition Science, Department of Biology and Biological engineering, Chalmers 14 10 University of Technology, Göteborg, Sweden. 2 15 11 Department of Obstetrics and Gynecology, Sahlgrenska University Hospital, Gothenburg, 16 12 Sweden. For peer review only 17 13 3Sunderby Research Unit, Region Norrbotten, Sweden. 18 14 4Department of Infectious Diseases, Institute of Biomedicine, the Sahlgrenska Academy, 19 15 University of Gothenburg, Göteborg, Sweden. 20 16 5Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden. 21 17 6Center of Neurodevelopmental Disorders (KIND), Division of Neuropsychiatry, Department 22 18 of Women’s and Children’s Health, Karolinska Institutet, Stockholm, Sweden. 23 7 24 19 Department of Paediatrics, Institute of Clinical Sciences, University of Gothenburg, 20 Göteborg, Sweden. 25 8 26 21 Department of Obstetrics and Gynecology, Institute of Clinical Sciences, the Sahlgrenska 27 22 Academy, University of Gothenburg, Göteborg, Sweden. 9 28 23 Department of Odontology/Cariology, Umeå University, Umeå, Sweden. 29 24 10Department of Clinical Sciences, Unit of Pediatrics, Umeå University, Umeå, Sweden. 30 25 31 26 Corresponding author: Malin Barman, Chalmers University of Technology, Department of 32 27 Biology and Biological Engineering, Food and Nutrition Science, SE-412 96 Gothenburg, 33 28 Sweden. Telephone: +46(0)31-7723811; Fax: +46(0)31-7723830; e mail: http://bmjopen.bmj.com/ 34 29 [email protected] 35 36 37 38 39 40 41 on September 28, 2021 by guest. Protected copyright. 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 1 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 28 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2018-022013 on 21 October 2018. Downloaded from 1 2 3 30 Abstract 4 5 31 Introduction 6 32 Pre- and neonatal environmental factors, such as nutrition, microbes and toxicants, may affect 7 33 health throughout life. Many diseases, such as allergy, and impaired child development may 8 34 be programmed already in utero or during early infancy. Birth-cohorts are important tools to 9 35 study associations between early life exposure and disease risk. Here, we describe the study 10 11 36 protocol of the prospective birth-cohort, “Nutritional impact on Immunological maturation 12 37 during Childhood in relation to the Environment” (NICE). The primary aim of the NICE- 13 38 cohort is to clarify the effect of key environmental exposures – diet, microbes and 14 39 environmental toxicants - during pregnancy and early childhood, on the maturation of the 15 40 infant’s immune system, including initiation of sensitisation and allergy. As the studied 16 41 exposures may alsoFor affect peerother outcomes, review the NICE-cohort only will investigate some secondary 17 42 outcomes: infant growth, obesity, neurological development and oral health. Banking of 18 43 samples will enable additional investigations into future biomarkers. 19 20 44 Methods and analysis 21 45 The NICE-cohort will recruit about 650 families during mid-pregnancy. The principal 22 46 inclusion criterion is planned birth at the Sunderby Hospital in the northern region of Sweden, 23 47 during 2015 – 2018. Questionnaires and biological samples are collected at ten time-points, 24 48 from pregnancy until the children reach four years-of-age. Samples are collected primarily 25 26 49 from mothers and children, but also from fathers. Biological samples include blood, urine, 27 50 placenta, breast milk, meconium, faeces, saliva and hair. Information regarding allergic 28 51 heredity, diet, socioeconomic status, life-style including smoking, siblings, pet ownership etc. 29 52 is collected using questionnaires. Sensitization to common allergens is assessed by skin-prick 30 53 testing and allergic disease is diagnosed by a paediatrician at one and four years of age. At 31 54 four years-of-age the children are also examined regarding growth, neurobehavioral and 32 55 neurophysiological status and oral health. 33 http://bmjopen.bmj.com/ 34 56 Ethics and dissemination 35 57 The NICE-cohort study protocol has been approved by the Regional Ethical Review Board in 36 58 Umeå, Sweden (2013/18-31M). 37 38 39 59 Key words (6 maximum) 40 60 Birth-cohort, allergy, immunology, nutrition, microbiology, toxicants. 41 on September 28, 2021 by guest. Protected copyright. 42 43 61 Strengths and limitations of this study 44 62 • Prospective study design covering a period from mid-pregnancy to the age of four 45 63 years with biological samples from mother, father and child for evaluation of 46 64 microbiology, nutrition, immunology, environmental toxicants, genetics and 47 48 65 epigenetics. 49 66 • Advanced analytical methods, including flow cytometry on fresh blood samples, 50 67 multi-omics methodologies and advanced exposure assessment methodologies. 51 68 • Interdiciplinary, translational approach with expertise in allergology, immunology, 52 69 nutrition, microbiology, toxicology, obstetrics, childhood growth, neurophysiological 53 70 development and oral health. 54 55 56 57 58 2 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 4 of 28 BMJ Open: first published as 10.1136/bmjopen-2018-022013 on 21 October 2018. Downloaded from 1 2 3 71 • The primary outcome, allergic disease (food allergy, atopic eczema, asthma and 4 72 allergic rhinoconjunctivitis) is diagnosed by a paediatric allergology specialist 5 73 according to strictly-defined protocols. 6 74 • Although the study sample will allow in depth analyses on multiple exposures, genetic 7 75 factors and outcomes, both frequences of potential factors and etiological 8 76 heterogeneity of outcomes may require follow up-studies.
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