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dc.creatorJiménez-Jorge, Silviaes
dc.creatorLabrador-Herrera, Gemaes
dc.creatorRosso-Fernández, Clara M.es
dc.creatorRodríguez-Torres, Nancyes
dc.creatorPachón-Ibáñez, María Eugeniaes
dc.creatorSmani, Youneses
dc.creatorEspigado Tocino, Ildefonsoes
dc.date.accessioned2023-07-07T09:53:30Z
dc.date.available2023-07-07T09:53:30Z
dc.date.issued2020
dc.identifier.citationJiménez-Jorge, S., Labrador-Herrera, G., Rosso-Fernández, C.M., Rodríguez-Torres, N., Pachón-Ibáñez, M.E., Smani, Y. y Espigado Tocino, I. (2020). Assessing the impact on intestinal microbiome and clinical outcomes of antibiotherapy optimisation strategies in haematopoietic stem cell transplant recipients: study protocol for the prospective multicentre OptimBioma study. BMJ Open, 10 (7), e034570. https://doi.org/10.1136/bmjopen-2019-034570.
dc.identifier.issn2044-6055es
dc.identifier.urihttps://hdl.handle.net/11441/147789
dc.description.abstractIntroduction: Haematopoietic stem cell transplantation (HSCT) is a life-saving treatment for a number of haematological diseases. Graft versus host disease (GVHD) is its main complication and hampers survival. There is strong evidence that intestinal microbiota diversity of the recipient may increase the risk of GVHD worsening survival. Antibiotic regimens used during the early phase of the transplant may influence clinical outcomes by reducing intestinal microbiota diversity. Present guidelines of European Conference on Infections in Leukaemia exhort to optimising antibiotic use in haematological patients including HSCT recipients. The present study aims to investigate if, in HSCT recipients, the optimisation of antibacterial use may preserve intestinal microbiota composition reducing the incidence and severity of acute GVHD and improving relevant clinical outcomes. Methods and analysis: This is a prospective longitudinal observational study of two cohorts of HSCT recipients: (1) the intervention cohort includes patients treated in centres in which a predefined strategy of antibiotherapy optimisation is implemented, with the objective of optimising and reducing antibiotic administration according to clinical criteria and (2) the control cohort includes patients treated in centres in which a classic permissive strategy of antibiotic prophylaxis and treatment is used. Adult patient receiving a first HSCT as a treatment for any haematological condition are included. Clinical variables are prospectively recorded and up to five faecal samples are collected for microbiota characterisation at prestablished peritransplant time points. Patients are followed since the preconditioning phase throughout 1-year post-transplant and four follow-up visits are scheduled. Faecal microbiota composition and diversity will be compared between both cohorts along with acute GVHD incidence and severity, severe infections rate, mortality and overall and disease-free survival. Ethics and dissemination: The study was approved between 2017 and 2018 by the Ethical Committees of participant centres. Study results will be disseminated through peer-reviewed journals and national and international scientific conferences.es
dc.formatapplication/pdfes
dc.format.extent7 pág.es
dc.language.isoenges
dc.publisherBMJ Publishing Groupes
dc.relation.ispartofBMJ Open, 10 (7), e034570.
dc.rightsAtribución-NoComercial 4.0 Internacional*
dc.rights.urihttp://creativecommons.org/licenses/by-nc/4.0/*
dc.subjectAntibioticses
dc.subjectGraft versus host diseasees
dc.subjectHematopoietic stem cell transplantationes
dc.subjectInfectionses
dc.subjectMicrobiomees
dc.subjectMicrobiotaes
dc.titleAssessing the impact on intestinal microbiome and clinical outcomes of antibiotherapy optimisation strategies in haematopoietic stem cell transplant recipients: study protocol for the prospective multicentre OptimBioma studyes
dc.typeinfo:eu-repo/semantics/articlees
dcterms.identifierhttps://ror.org/03yxnpp24
dc.type.versioninfo:eu-repo/semantics/publishedVersiones
dc.rights.accessRightsinfo:eu-repo/semantics/openAccesses
dc.contributor.affiliationUniversidad de Sevilla. Departamento de Medicinaes
dc.relation.projectIDPI16/02010es
dc.relation.projectIDPI16/02010es
dc.relation.projectIDPI16/02010es
dc.relation.projectIDPT17/0017/0012es
dc.relation.publisherversionhttps://bmjopen.bmj.com/content/10/7/e034570es
dc.identifier.doi10.1136/bmjopen-2019-034570es
dc.journaltitleBMJ Openes
dc.publication.volumen10es
dc.publication.issue7es
dc.publication.initialPagee034570es
dc.contributor.funderEuropean Union (ERDF/ESF, `Investing in your future')es
dc.contributor.funderInstituto de Salud Carlos III - European Regional Development Fund/European Social Fund A way to make Europe'/`Investing in your future'es
dc.contributor.funderInstituto de Salud Carlos III (ISCIII)es
dc.contributor.funderInstituto de Salud Carlos III through the project - European Regional Development Fund/European Social Fundes
dc.contributor.funderPlan Nacional de I+D+ i 2013-2016 and Instituto de Salud Carlos III, Subdireccion General de Evaluacion y Fomento de la Investigacion, Ministerio de Economia, Industria y Competitividad, Spanish Clinical Research and Clinical Trials Platform (SCReN)es
dc.contributor.funderSubdireccion General de Redes y Centros de Investigacion Cooperativa, Ministerio de Economia, Industria y Competitividad, Spanish Network for Research in Infectious Diseases (REIPI) - European Development Regional Fundes

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