Relationship between vaginal and gut microbiome and pregnancy outcomes in eastern Ethiopia: a protocol for a longitudinal maternal-infant cohort study (the EthiOMICS study)

Introduction Although evidence exists on the impact of microbiota on pregnancy outcomes in many high-resource settings, there is a lack of research in many low-resource settings like Ethiopia. This study aims to fill this gap by studying the gut and vaginal microbiota changes throughout pregnancy an...

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Main Authors: Piet Cools, Alemseged Abdissa, Abera Kenay Tura, Nega Assefa, Merga Dheresa, Kedir Teji Roba, Tara Wilfong, Tesfaye Assebe Yadeta, Fitsum Weldegebreal, Desalegn Admassu Ayana, Akewok Sime Negesa, Yohannes Mulugeta Demmu, Tewodros Tesfa, Tegbaru Nibrat Alemu, Tadesse Gure Eticha, Abraham Geremew, Abel Abera Negash
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Language:English
Published: BMJ Publishing Group 2025-01-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/15/1/e092461.full
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author Piet Cools
Alemseged Abdissa
Abera Kenay Tura
Nega Assefa
Merga Dheresa
Kedir Teji Roba
Tara Wilfong
Tesfaye Assebe Yadeta
Fitsum Weldegebreal
Desalegn Admassu Ayana
Akewok Sime Negesa
Yohannes Mulugeta Demmu
Tewodros Tesfa
Tegbaru Nibrat Alemu
Tadesse Gure Eticha
Abraham Geremew
Abel Abera Negash
author_facet Piet Cools
Alemseged Abdissa
Abera Kenay Tura
Nega Assefa
Merga Dheresa
Kedir Teji Roba
Tara Wilfong
Tesfaye Assebe Yadeta
Fitsum Weldegebreal
Desalegn Admassu Ayana
Akewok Sime Negesa
Yohannes Mulugeta Demmu
Tewodros Tesfa
Tegbaru Nibrat Alemu
Tadesse Gure Eticha
Abraham Geremew
Abel Abera Negash
author_sort Piet Cools
collection DOAJ
description Introduction Although evidence exists on the impact of microbiota on pregnancy outcomes in many high-resource settings, there is a lack of research in many low-resource settings like Ethiopia. This study aims to fill this gap by studying the gut and vaginal microbiota changes throughout pregnancy and assess how these changes relate to pregnancy outcomes among a cohort of pregnant women in eastern Ethiopia.Methods and analysis Vaginal and stool samples will be collected using DNA/RNA Shield Collection kits three times starting at 12–22 weeks, 28–36 weeks and at birth (within 7 days). Postnatally, newborns’ skin swabs (at birth) and rectal swabs will be obtained until 2 years of age. Moreover, breast milk samples at birth and 6 months and environmental samples (water, indoor air and soil) will be collected at enrolment, birth, 6, 12 and 24 months post partum. DNA will be extracted using Roche kits. Metagenomic sequencing will be performed to identify metataxonomic profiling and assess variations in microbial profiles, and α and β diversity of the microbiota. Information on socioeconomic, behavioural, household and biological factors will be collected at enrolment. The collected data will be coded, entered into EpiData 3.1 and analysed using Stata 17.Ethics and dissemination The Institutional Health Research Ethics Review Committee (Ref No. IHRERC/033/2022) of Haramaya University, Ethiopia has approved this study ethically. Written informed consent regarding the study and sample storage for biobanking will be obtained from all participants. Results will be published in international peer-reviewed journals, and summaries will be provided to the study funders. Clinical study data will be submitted to Data Compass (https://datacompass.lshtm.ac.uk/), and molecular profiles of the microbiome and whole-genome sequences will be submitted to the European Nucleotide Archive (https://www. ebi.ac.uk/ena). Requests for data should be directed to daberaf@gmail.com. The decision to share data will be made by the study steering committee under the College of Health and Medical Sciences, Haramaya University, Ethiopia.
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spelling doaj-art-e06e0a6f179640a58b4baa5371bdaad12025-08-20T02:43:38ZengBMJ Publishing GroupBMJ Open2044-60552025-01-0115110.1136/bmjopen-2024-092461Relationship between vaginal and gut microbiome and pregnancy outcomes in eastern Ethiopia: a protocol for a longitudinal maternal-infant cohort study (the EthiOMICS study)Piet Cools0Alemseged Abdissa1Abera Kenay Tura2Nega Assefa3Merga Dheresa4Kedir Teji Roba5Tara Wilfong6Tesfaye Assebe Yadeta7Fitsum Weldegebreal8Desalegn Admassu Ayana9Akewok Sime Negesa10Yohannes Mulugeta Demmu11Tewodros Tesfa12Tegbaru Nibrat Alemu13Tadesse Gure Eticha14Abraham Geremew15Abel Abera Negash162 Laboratory Bacteriology Research, Department of Diagnostic Sciences, Ghent University Faculty of Medicine and Health Sciences, Gent, Belgium7 Armauer Hansen Research Institute, Addis Ababa, Ethiopia4 School of Nursing, Haramaya University College of Health and Medical Sciences, Harar, Ethiopia4 School of Nursing, Haramaya University College of Health and Medical Sciences, Harar, Ethiopia4 School of Nursing, Haramaya University College of Health and Medical Sciences, Harar, Ethiopia4 School of Nursing, Haramaya University College of Health and Medical Sciences, Harar, Ethiopia3 School of Public Health, Haramaya University College of Health and Medical Sciences, Harar, Ethiopia4 School of Nursing, Haramaya University College of Health and Medical Sciences, Harar, Ethiopia2 Laboratory Bacteriology Research, Department of Diagnostic Sciences, Ghent University Faculty of Medicine and Health Sciences, Gent, Belgium1 School of Medical Laboratory Sciences, Haramaya University College of Health and Medical Sciences, Harar, Ethiopia1 School of Medical Laboratory Sciences, Haramaya University College of Health and Medical Sciences, Harar, Ethiopia5 School of Environmental Health, Haramaya University College of Health and Medical Sciences, Harar, Ethiopia1 School of Medical Laboratory Sciences, Haramaya University College of Health and Medical Sciences, Harar, Ethiopia5 School of Environmental Health, Haramaya University College of Health and Medical Sciences, Harar, Ethiopia6 School of Medicine, Haramaya University College of Health and Medical Sciences, Harar, Ethiopia5 School of Environmental Health, Haramaya University College of Health and Medical Sciences, Harar, Ethiopia7 Armauer Hansen Research Institute, Addis Ababa, EthiopiaIntroduction Although evidence exists on the impact of microbiota on pregnancy outcomes in many high-resource settings, there is a lack of research in many low-resource settings like Ethiopia. This study aims to fill this gap by studying the gut and vaginal microbiota changes throughout pregnancy and assess how these changes relate to pregnancy outcomes among a cohort of pregnant women in eastern Ethiopia.Methods and analysis Vaginal and stool samples will be collected using DNA/RNA Shield Collection kits three times starting at 12–22 weeks, 28–36 weeks and at birth (within 7 days). Postnatally, newborns’ skin swabs (at birth) and rectal swabs will be obtained until 2 years of age. Moreover, breast milk samples at birth and 6 months and environmental samples (water, indoor air and soil) will be collected at enrolment, birth, 6, 12 and 24 months post partum. DNA will be extracted using Roche kits. Metagenomic sequencing will be performed to identify metataxonomic profiling and assess variations in microbial profiles, and α and β diversity of the microbiota. Information on socioeconomic, behavioural, household and biological factors will be collected at enrolment. The collected data will be coded, entered into EpiData 3.1 and analysed using Stata 17.Ethics and dissemination The Institutional Health Research Ethics Review Committee (Ref No. IHRERC/033/2022) of Haramaya University, Ethiopia has approved this study ethically. Written informed consent regarding the study and sample storage for biobanking will be obtained from all participants. Results will be published in international peer-reviewed journals, and summaries will be provided to the study funders. Clinical study data will be submitted to Data Compass (https://datacompass.lshtm.ac.uk/), and molecular profiles of the microbiome and whole-genome sequences will be submitted to the European Nucleotide Archive (https://www. ebi.ac.uk/ena). Requests for data should be directed to daberaf@gmail.com. The decision to share data will be made by the study steering committee under the College of Health and Medical Sciences, Haramaya University, Ethiopia.https://bmjopen.bmj.com/content/15/1/e092461.full
spellingShingle Piet Cools
Alemseged Abdissa
Abera Kenay Tura
Nega Assefa
Merga Dheresa
Kedir Teji Roba
Tara Wilfong
Tesfaye Assebe Yadeta
Fitsum Weldegebreal
Desalegn Admassu Ayana
Akewok Sime Negesa
Yohannes Mulugeta Demmu
Tewodros Tesfa
Tegbaru Nibrat Alemu
Tadesse Gure Eticha
Abraham Geremew
Abel Abera Negash
Relationship between vaginal and gut microbiome and pregnancy outcomes in eastern Ethiopia: a protocol for a longitudinal maternal-infant cohort study (the EthiOMICS study)
BMJ Open
title Relationship between vaginal and gut microbiome and pregnancy outcomes in eastern Ethiopia: a protocol for a longitudinal maternal-infant cohort study (the EthiOMICS study)
title_full Relationship between vaginal and gut microbiome and pregnancy outcomes in eastern Ethiopia: a protocol for a longitudinal maternal-infant cohort study (the EthiOMICS study)
title_fullStr Relationship between vaginal and gut microbiome and pregnancy outcomes in eastern Ethiopia: a protocol for a longitudinal maternal-infant cohort study (the EthiOMICS study)
title_full_unstemmed Relationship between vaginal and gut microbiome and pregnancy outcomes in eastern Ethiopia: a protocol for a longitudinal maternal-infant cohort study (the EthiOMICS study)
title_short Relationship between vaginal and gut microbiome and pregnancy outcomes in eastern Ethiopia: a protocol for a longitudinal maternal-infant cohort study (the EthiOMICS study)
title_sort relationship between vaginal and gut microbiome and pregnancy outcomes in eastern ethiopia a protocol for a longitudinal maternal infant cohort study the ethiomics study
url https://bmjopen.bmj.com/content/15/1/e092461.full
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