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  • Cross-sectional observational study protocol: missing microbes in infants born by caesarean section (MiMIC): antenatal antibiotics and mode of delivery

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Research methods
Protocol
Cross-sectional observational study protocol: missing microbes in infants born by caesarean section (MiMIC): antenatal antibiotics and mode of delivery
  1. Alicja K Warda1,2,
  2. Eugene M Dempsey1,3,4,
  3. Sofia D Forssten5,
  4. C Anthony Ryan1,3,
  5. John F Cryan1,6,
  6. Elaine Patterson5,
  7. Mairead N O'Riordan1,3,
  8. Carol-Anne O’Shea1,3,
  9. Finola Keohane1,3,
  10. Grainne Meehan1,3,
  11. Orlagh O’Connor1,3,
  12. R Paul Ross1,6,
  13. Catherine Stanton1,2
  1. 1APC Microbiome Ireland, Cork, Ireland
  2. 2Food Research Centre Moorepark, Teagasc, Moorepark, Ireland
  3. 3Cork University Maternity Hospital, Cork, Ireland
  4. 4INFANT Research Centre, University College Cork, Cork, Ireland
  5. 5IFF Health & Bioscience, Kantvik, Finland
  6. 6University College Cork, Cork, Ireland
  1. Correspondence to Dr Catherine Stanton; catherine.stanton{at}teagasc.ie

Abstract

Introduction The intestinal microbiome in early life plays a major role in infant health and development. Factors like antibiotic exposure, breast/formula feeding and mode of delivery are known to affect the microbiome. The increasing occurrence of caesarean section (C-section) deliveries and antibiotic exposure warrants further insight into the potential missing microbes in those infants. The study objective is to study the effect of maternal antibiotic administration during pregnancy and/or C-section mode of delivery on the development of the infant’s intestinal microbiome until the age of 2 years.

Methods and analysis A single site, cross-sectional observational study of C-section and vaginally delivered infants being either exposed to maternal antibiotic treatment or not during the third trimester of pregnancy. Throughout the nine visits, stool, urine, saliva, hair, breast milk and vaginal swabs will be collected from either mother and/or infant for microbiome and metabolomic analysis.

Ethics and dissemination The protocol was approved by the Clinical Research Ethics Committee of the Cork Teaching Hospitals. The trial has been registered at ClinicalTrials.gov.

The findings from this study will be disseminated in peer-reviewed journals, during scientific conferences, and directly to the study participants. Sequencing data will be deposited in public databases.

Trial registration number NCT04134819.

  • MICROBIOLOGY
  • PAEDIATRICS
  • OBSTETRICS
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2022-064398

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    Footnotes

    • Contributors AKW wrote the manuscript. EMD, SDF, CAR, JFC, EP, MNO’R, C-AO'S, RPR and CS were involved in the study design and writing of the manuscript. C-AO’S, FK, GM and OO’C were involved in consenting participants and collecting samples. All authors read and approved the final manuscript.

    • Funding This publication has emanated from research conducted with financial support of Science Foundation Ireland under Grant No. 12/RC/2273_P2 and 19/SP/6989. This publication has emanated from research conducted with financial support of International Flavors & Fragrances (IFF).

    • Competing interests JFC has been an invited speaker at meetings organised by Mead Johnson, Yakult, Nutricia, Pepsi and Friesland Campina and has received research funding from Cremo, IFF, Pharmavite, Mead Johnson and Nutricia; and has been a consultant for Nestle. SDF is an employee of IFF Health & Biosciences that manufactures and commercialises probiotics, while EP was an employee of IFF Health & Biosciences at the time this manuscript was prepared.

    • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.