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Gut microbiota and intestinal rehabilitation: A prospective childhood cohort longitudinal study of short bowel syndrome (the MIRACLS study): Study protocol

Lookup NU author(s): Dr Jemma Cleminson, Dr Julian Thomas, Professor Christopher StewartORCiD, Dr David Campbell, Professor Andrew GenneryORCiD, Professor Nicholas EmbletonORCiD, Professor Janet Berrington

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This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License (CC BY-NC 4.0).


Abstract

© Author(s) (or their employer(s)) 2024.Introduction Short bowel syndrome (SBS) is the predominant cause of paediatric intestinal failure. Although life-saving, parenteral nutrition (PN) is linked to complications and may impact quality of life (QoL). Most children will experience intestinal rehabilitation (IR), but the mechanisms underpinning this remain to be understood. SBS is characterised by abnormal microbiome patterns, which might serve as predictive indicators for IR. We aim to characterise the microbiome profiles of children with SBS during IR, concurrently exploring how parental perspectives of QoL relate to IR. Methods and analysis This study will enrol a minimum of 20 paediatric patients with SBS (0-18 years). Clinical data and biological samples will be collected over a 2-year study period. We will apply 16S rRNA gene sequencing to analyse the microbiome from faecal and gut tissue samples, with additional shotgun metagenomic sequencing specifically on samples obtained around the time of IR. Gas chromatography with flame ionisation detection will profile faecal short-chain fatty acids. Plasma citrulline and urinary intestinal fatty acid binding proteins will be measured annually. We will explore microbiome-clinical covariate interactions. Furthermore, we plan to assess parental perspectives on QoL during PN and post-IR by inviting parents to complete the Paediatric Quality of Life questionnaire at recruitment and after the completion of IR. Ethics and dissemination Ethical approval was obtained from the East Midlands-Nottingham 2 Research Ethics Committee (22/EM/0233; 28 November 2022). Recruitment began in February 2023. Outcomes of the study will be published in peer-reviewed scientific journals and presented at scientific meetings. A lay summary of the results will be made available to participants and the public. Trial registration number ISRCTN90620576.


Publication metadata

Author(s): Cleminson JS, Thomas J, Stewart CJ, Campbell D, Gennery A, Embleton ND, Koglmeier J, Wong T, Spruce M, Berrington JE

Publication type: Article

Publication status: Published

Journal: BMJ Open Gastroenterology

Year: 2024

Volume: 11

Issue: 1

Print publication date: 17/08/2024

Online publication date: 17/08/2024

Acceptance date: 29/07/2024

Date deposited: 28/10/2024

ISSN (electronic): 2054-4774

Publisher: BMJ Publishing Group

URL: https://doi.org/10.1136/bmjgast-2024-001450

DOI: 10.1136/bmjgast-2024-001450

Data Access Statement: No data are available.


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Funding

Funder referenceFunder name
7718
Newcastle Hospitals Charity

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