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Protocol: Faecal microbiota transfer in liver cancer to overcome resistance to atezolizumab/bevacizumab - a multicentre, randomised, placebo-controlled, double-blind phase II trial (the FLORA trial).

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Title: Protocol: Faecal microbiota transfer in liver cancer to overcome resistance to atezolizumab/bevacizumab - a multicentre, randomised, placebo-controlled, double-blind phase II trial (the FLORA trial).
Authors: Rauber C; Department of Gastroenterology, Hepatology, Infectious Diseases and Intoxication, University Hospital Heidelberg, Heidelberg, Germany conrad.rauber@med.uni-heidelberg.de.; Liver Cancer Center Heidelberg (LCCH), Heidelberg, Germany., Roberti MP; Clinical Cooperation Unit Applied Tumor Immunity, DKFZ, Heidelberg, Germany.; Department of Medical Oncology and Internal Medicine VI, Medical Faculty Heidelberg, University Hospital Heidelberg, Heidelberg, Germany.; NCT Heidelberg, a partnership between DKFZ and Heidelberg University Hospital, NCT, Heidelberg, Germany., Vehreschild MJ; Department of Internal Medicine, Infectious Diseases, Goethe University Frankfurt, University Hospital Frankfurt, Department of Internal Medicine, Frankfurt, Germany.; Partner Site Bonn-Cologne, German Center for Infection Research (DZIF), Cologne, Germany.; Department I of Internal Medicine, University Hospital Cologne, Cologne, Germany., Tsakmaklis A; Department I of Internal Medicine, University of Cologne, Cologne, Germany.; German Center for Infection Research, Cologne, Germany., Springfeld C; Liver Cancer Center Heidelberg (LCCH), Heidelberg, Germany.; Department of Medical Oncology and Internal Medicine VI, Medical Faculty Heidelberg, University Hospital Heidelberg, Heidelberg, Germany.; NCT Heidelberg, a partnership between DKFZ and Heidelberg University Hospital, NCT, Heidelberg, Germany., Teufel A; Liver Cancer Center Heidelberg (LCCH), Heidelberg, Germany.; Department of Medicine II, Heidelberg University Medical Faculty Mannheim, Mannheim, Germany., Ettrich T; Department of Internal Medicine I, Ulm University Hospital, Ulm, Germany., Jochheim L; Department of Gastroenterology, Hepatology and Transplant Medicine, University of Duisburg-Essen, Duisburg, Germany., Kandulski A; Department of Internal Medicine I, Gastroenterology, Hepatology, Endocrinology, Rheumatology, and Infectious Diseases, University Hospital Regensburg, Regensburg, Germany., Missios P; Department of Internal Medicine I, University Hospital Tübingen, Tübingen, Germany., Mohr R; Department of Hepatology and Gastroenterology, Charité - UniversitätsmedizinBerlin, Campus Virchow Klinikum (CVK) and Campus Charité Mitte (CCM), Charite Universitatsmedizin Berlin, Berlin, Germany., Reichart A; Department of Gastroenterology, University Hospital Augsburg, Augsburg, Germany., Waldschmidt DT; Department for Gastroenterology and Hepatology, University Hospital Cologne, Cologne, Germany., Sauer LD; Institute of Medical Biometry (IMBI), Heidelberg University, Heidelberg, Germany., Sander A; Institute of Medical Biometry (IMBI), Heidelberg University, Heidelberg, Germany., Schirmacher P; Liver Cancer Center Heidelberg (LCCH), Heidelberg, Germany.; Institute of Pathology, University Hospital Heidelberg, Heidelberg, Germany., Jäger D; Clinical Cooperation Unit Applied Tumor Immunity, DKFZ, Heidelberg, Germany.; Department of Medical Oncology and Internal Medicine VI, Medical Faculty Heidelberg, University Hospital Heidelberg, Heidelberg, Germany.; NCT Heidelberg, a partnership between DKFZ and Heidelberg University Hospital, NCT, Heidelberg, Germany., Michl P; Department of Gastroenterology, Hepatology, Infectious Diseases and Intoxication, University Hospital Heidelberg, Heidelberg, Germany.; Liver Cancer Center Heidelberg (LCCH), Heidelberg, Germany., Dill MT; Department of Gastroenterology, Hepatology, Infectious Diseases and Intoxication, University Hospital Heidelberg, Heidelberg, Germany.; Liver Cancer Center Heidelberg (LCCH), Heidelberg, Germany.; NCT Heidelberg, a partnership between DKFZ and Heidelberg University Hospital, NCT, Heidelberg, Germany.; Research Group Experimental Hepatology, Inflammation and Cancer, DKFZ, Heidelberg, Germany.
Source: BMJ open [BMJ Open] 2025 Sep 09; Vol. 15 (9), pp. e097802. Date of Electronic Publication: 2025 Sep 09.
Publication Type: Journal Article; Clinical Trial Protocol
Journal Info: Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE
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  Data: Protocol: Faecal microbiota transfer in liver cancer to overcome resistance to atezolizumab/bevacizumab - a multicentre, randomised, placebo-controlled, double-blind phase II trial (the FLORA trial).
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  Data: <searchLink fieldCode="AU" term="%22Rauber+C%22">Rauber C</searchLink>; Department of Gastroenterology, Hepatology, Infectious Diseases and Intoxication, University Hospital Heidelberg, Heidelberg, Germany conrad.rauber@med.uni-heidelberg.de.; Liver Cancer Center Heidelberg (LCCH), Heidelberg, Germany.<br /><searchLink fieldCode="AU" term="%22Roberti+MP%22">Roberti MP</searchLink>; Clinical Cooperation Unit Applied Tumor Immunity, DKFZ, Heidelberg, Germany.; Department of Medical Oncology and Internal Medicine VI, Medical Faculty Heidelberg, University Hospital Heidelberg, Heidelberg, Germany.; NCT Heidelberg, a partnership between DKFZ and Heidelberg University Hospital, NCT, Heidelberg, Germany.<br /><searchLink fieldCode="AU" term="%22Vehreschild+MJ%22">Vehreschild MJ</searchLink>; Department of Internal Medicine, Infectious Diseases, Goethe University Frankfurt, University Hospital Frankfurt, Department of Internal Medicine, Frankfurt, Germany.; Partner Site Bonn-Cologne, German Center for Infection Research (DZIF), Cologne, Germany.; Department I of Internal Medicine, University Hospital Cologne, Cologne, Germany.<br /><searchLink fieldCode="AU" term="%22Tsakmaklis+A%22">Tsakmaklis A</searchLink>; Department I of Internal Medicine, University of Cologne, Cologne, Germany.; German Center for Infection Research, Cologne, Germany.<br /><searchLink fieldCode="AU" term="%22Springfeld+C%22">Springfeld C</searchLink>; Liver Cancer Center Heidelberg (LCCH), Heidelberg, Germany.; Department of Medical Oncology and Internal Medicine VI, Medical Faculty Heidelberg, University Hospital Heidelberg, Heidelberg, Germany.; NCT Heidelberg, a partnership between DKFZ and Heidelberg University Hospital, NCT, Heidelberg, Germany.<br /><searchLink fieldCode="AU" term="%22Teufel+A%22">Teufel A</searchLink>; Liver Cancer Center Heidelberg (LCCH), Heidelberg, Germany.; Department of Medicine II, Heidelberg University Medical Faculty Mannheim, Mannheim, Germany.<br /><searchLink fieldCode="AU" term="%22Ettrich+T%22">Ettrich T</searchLink>; Department of Internal Medicine I, Ulm University Hospital, Ulm, Germany.<br /><searchLink fieldCode="AU" term="%22Jochheim+L%22">Jochheim L</searchLink>; Department of Gastroenterology, Hepatology and Transplant Medicine, University of Duisburg-Essen, Duisburg, Germany.<br /><searchLink fieldCode="AU" term="%22Kandulski+A%22">Kandulski A</searchLink>; Department of Internal Medicine I, Gastroenterology, Hepatology, Endocrinology, Rheumatology, and Infectious Diseases, University Hospital Regensburg, Regensburg, Germany.<br /><searchLink fieldCode="AU" term="%22Missios+P%22">Missios P</searchLink>; Department of Internal Medicine I, University Hospital Tübingen, Tübingen, Germany.<br /><searchLink fieldCode="AU" term="%22Mohr+R%22">Mohr R</searchLink>; Department of Hepatology and Gastroenterology, Charité - UniversitätsmedizinBerlin, Campus Virchow Klinikum (CVK) and Campus Charité Mitte (CCM), Charite Universitatsmedizin Berlin, Berlin, Germany.<br /><searchLink fieldCode="AU" term="%22Reichart+A%22">Reichart A</searchLink>; Department of Gastroenterology, University Hospital Augsburg, Augsburg, Germany.<br /><searchLink fieldCode="AU" term="%22Waldschmidt+DT%22">Waldschmidt DT</searchLink>; Department for Gastroenterology and Hepatology, University Hospital Cologne, Cologne, Germany.<br /><searchLink fieldCode="AU" term="%22Sauer+LD%22">Sauer LD</searchLink>; Institute of Medical Biometry (IMBI), Heidelberg University, Heidelberg, Germany.<br /><searchLink fieldCode="AU" term="%22Sander+A%22">Sander A</searchLink>; Institute of Medical Biometry (IMBI), Heidelberg University, Heidelberg, Germany.<br /><searchLink fieldCode="AU" term="%22Schirmacher+P%22">Schirmacher P</searchLink>; Liver Cancer Center Heidelberg (LCCH), Heidelberg, Germany.; Institute of Pathology, University Hospital Heidelberg, Heidelberg, Germany.<br /><searchLink fieldCode="AU" term="%22Jäger+D%22">Jäger D</searchLink>; Clinical Cooperation Unit Applied Tumor Immunity, DKFZ, Heidelberg, Germany.; Department of Medical Oncology and Internal Medicine VI, Medical Faculty Heidelberg, University Hospital Heidelberg, Heidelberg, Germany.; NCT Heidelberg, a partnership between DKFZ and Heidelberg University Hospital, NCT, Heidelberg, Germany.<br /><searchLink fieldCode="AU" term="%22Michl+P%22">Michl P</searchLink>; Department of Gastroenterology, Hepatology, Infectious Diseases and Intoxication, University Hospital Heidelberg, Heidelberg, Germany.; Liver Cancer Center Heidelberg (LCCH), Heidelberg, Germany.<br /><searchLink fieldCode="AU" term="%22Dill+MT%22">Dill MT</searchLink>; Department of Gastroenterology, Hepatology, Infectious Diseases and Intoxication, University Hospital Heidelberg, Heidelberg, Germany.; Liver Cancer Center Heidelberg (LCCH), Heidelberg, Germany.; NCT Heidelberg, a partnership between DKFZ and Heidelberg University Hospital, NCT, Heidelberg, Germany.; Research Group Experimental Hepatology, Inflammation and Cancer, DKFZ, Heidelberg, Germany.
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  Data: <searchLink fieldCode="JN" term="%22101552874%22">BMJ open</searchLink> [BMJ Open] 2025 Sep 09; Vol. 15 (9), pp. e097802. <i>Date of Electronic Publication: </i>2025 Sep 09.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22BMJ+Publishing+Group+Ltd%22">BMJ Publishing Group Ltd </searchLink><i>Country of Publication: </i>England <i>NLM ID: </i>101552874 <i>Publication Model: </i>Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>2044-6055 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2220446055%22">20446055 </searchLink><i>NLM ISO Abbreviation: </i>BMJ Open <i>Subsets: </i>MEDLINE
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