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Fecal microbiota transplantation to reduce immune activation in ART-treated people with HIV with low CD4/CD8 ratio: protocol for the single-blind, randomized, placebo-controlled Gutsy study (CIHR/CTN PT038).

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Title: Fecal microbiota transplantation to reduce immune activation in ART-treated people with HIV with low CD4/CD8 ratio: protocol for the single-blind, randomized, placebo-controlled Gutsy study (CIHR/CTN PT038).
Authors: Isnard S; Infectious Diseases and Immunity in Global Health Program, Research Institute, McGill University Health Centre, Montréal, QC, Canada.; Department of Medicine, Division of Infectious Diseases and Chronic Viral Illness Service, McGill University Health Centre, Montréal, QC, Canada.; CIHR Canadian HIV Trials Network, Vancouver, BC, Canada., Berini CA; Infectious Diseases and Immunity in Global Health Program, Research Institute, McGill University Health Centre, Montréal, QC, Canada.; Department of Medicine, Division of Infectious Diseases and Chronic Viral Illness Service, McGill University Health Centre, Montréal, QC, Canada., Parvathy SN; Department of Medicine, Division of Infectious Diseases, Western University, London, Ontario, Canada.; Lawson Research Institute, St Joseph's Health Care, London, Ontario, Canada., Feng H; Infectious Diseases and Immunity in Global Health Program, Research Institute, McGill University Health Centre, Montréal, QC, Canada., Aiyana O; Infectious Diseases and Immunity in Global Health Program, Research Institute, McGill University Health Centre, Montréal, QC, Canada., Royston L; Infectious Diseases and Immunity in Global Health Program, Research Institute, McGill University Health Centre, Montréal, QC, Canada.; Department of Medicine, Division of Infectious Diseases and Chronic Viral Illness Service, McGill University Health Centre, Montréal, QC, Canada.; CIHR Canadian HIV Trials Network, Vancouver, BC, Canada.; Division of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland., Mabanga T; Infectious Diseases and Immunity in Global Health Program, Research Institute, McGill University Health Centre, Montréal, QC, Canada.; Department of Medicine, Division of Infectious Diseases and Chronic Viral Illness Service, McGill University Health Centre, Montréal, QC, Canada., Lakatos PL; Division of Gastroenterology, McGill University Health Center, Montréal, QC, Canada., Bessissow T; Division of Gastroenterology, McGill University Health Center, Montréal, QC, Canada., Klein MB; Infectious Diseases and Immunity in Global Health Program, Research Institute, McGill University Health Centre, Montréal, QC, Canada.; Department of Medicine, Division of Infectious Diseases and Chronic Viral Illness Service, McGill University Health Centre, Montréal, QC, Canada.; CIHR Canadian HIV Trials Network, Vancouver, BC, Canada., Lebouché B; Infectious Diseases and Immunity in Global Health Program, Research Institute, McGill University Health Centre, Montréal, QC, Canada.; Department of Medicine, Division of Infectious Diseases and Chronic Viral Illness Service, McGill University Health Centre, Montréal, QC, Canada.; Centre for Outcomes Research and Evaluation, Research Institute of the McGill University Health Centre, Montréal, QC, Canada.; Department of Family Medicine, McGill University Health Centre, Montréal, QC, Canada., Costiniuk CT; Infectious Diseases and Immunity in Global Health Program, Research Institute, McGill University Health Centre, Montréal, QC, Canada.; Department of Medicine, Division of Infectious Diseases and Chronic Viral Illness Service, McGill University Health Centre, Montréal, QC, Canada., Routy B; Centre de Recherche du Centre Hospitalier de L'Université de Montréal, Montreal, QC, Canada.; Hemato-oncology division, Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, QC, Canada., Silverman MS; Department of Medicine, Division of Infectious Diseases, Western University, London, Ontario, Canada.; Lawson Research Institute, St Joseph's Health Care, London, Ontario, Canada.; Division of Infectious Diseases, St Joseph's Health Care, London, ON, Canada., Routy JP; Infectious Diseases and Immunity in Global Health Program, Research Institute, McGill University Health Centre, Montréal, QC, Canada. jean-pierre.routy@mcgill.ca.; Department of Medicine, Division of Infectious Diseases and Chronic Viral Illness Service, McGill University Health Centre, Montréal, QC, Canada. jean-pierre.routy@mcgill.ca.; Division of Hematology, McGill University Health Centre, Montréal, QC, Canada. jean-pierre.routy@mcgill.ca.
Source: Trials [Trials] 2025 Dec 13; Vol. 27 (1), pp. 52. Date of Electronic Publication: 2025 Dec 13.
Publication Type: Journal Article; Clinical Trial Protocol
Journal Info: Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE
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  Data: Fecal microbiota transplantation to reduce immune activation in ART-treated people with HIV with low CD4/CD8 ratio: protocol for the single-blind, randomized, placebo-controlled Gutsy study (CIHR/CTN PT038).
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  Data: <searchLink fieldCode="AU" term="%22Isnard+S%22">Isnard S</searchLink>; Infectious Diseases and Immunity in Global Health Program, Research Institute, McGill University Health Centre, Montréal, QC, Canada.; Department of Medicine, Division of Infectious Diseases and Chronic Viral Illness Service, McGill University Health Centre, Montréal, QC, Canada.; CIHR Canadian HIV Trials Network, Vancouver, BC, Canada.<br /><searchLink fieldCode="AU" term="%22Berini+CA%22">Berini CA</searchLink>; Infectious Diseases and Immunity in Global Health Program, Research Institute, McGill University Health Centre, Montréal, QC, Canada.; Department of Medicine, Division of Infectious Diseases and Chronic Viral Illness Service, McGill University Health Centre, Montréal, QC, Canada.<br /><searchLink fieldCode="AU" term="%22Parvathy+SN%22">Parvathy SN</searchLink>; Department of Medicine, Division of Infectious Diseases, Western University, London, Ontario, Canada.; Lawson Research Institute, St Joseph's Health Care, London, Ontario, Canada.<br /><searchLink fieldCode="AU" term="%22Feng+H%22">Feng H</searchLink>; Infectious Diseases and Immunity in Global Health Program, Research Institute, McGill University Health Centre, Montréal, QC, Canada.<br /><searchLink fieldCode="AU" term="%22Aiyana+O%22">Aiyana O</searchLink>; Infectious Diseases and Immunity in Global Health Program, Research Institute, McGill University Health Centre, Montréal, QC, Canada.<br /><searchLink fieldCode="AU" term="%22Royston+L%22">Royston L</searchLink>; Infectious Diseases and Immunity in Global Health Program, Research Institute, McGill University Health Centre, Montréal, QC, Canada.; Department of Medicine, Division of Infectious Diseases and Chronic Viral Illness Service, McGill University Health Centre, Montréal, QC, Canada.; CIHR Canadian HIV Trials Network, Vancouver, BC, Canada.; Division of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland.<br /><searchLink fieldCode="AU" term="%22Mabanga+T%22">Mabanga T</searchLink>; Infectious Diseases and Immunity in Global Health Program, Research Institute, McGill University Health Centre, Montréal, QC, Canada.; Department of Medicine, Division of Infectious Diseases and Chronic Viral Illness Service, McGill University Health Centre, Montréal, QC, Canada.<br /><searchLink fieldCode="AU" term="%22Lakatos+PL%22">Lakatos PL</searchLink>; Division of Gastroenterology, McGill University Health Center, Montréal, QC, Canada.<br /><searchLink fieldCode="AU" term="%22Bessissow+T%22">Bessissow T</searchLink>; Division of Gastroenterology, McGill University Health Center, Montréal, QC, Canada.<br /><searchLink fieldCode="AU" term="%22Klein+MB%22">Klein MB</searchLink>; Infectious Diseases and Immunity in Global Health Program, Research Institute, McGill University Health Centre, Montréal, QC, Canada.; Department of Medicine, Division of Infectious Diseases and Chronic Viral Illness Service, McGill University Health Centre, Montréal, QC, Canada.; CIHR Canadian HIV Trials Network, Vancouver, BC, Canada.<br /><searchLink fieldCode="AU" term="%22Lebouché+B%22">Lebouché B</searchLink>; Infectious Diseases and Immunity in Global Health Program, Research Institute, McGill University Health Centre, Montréal, QC, Canada.; Department of Medicine, Division of Infectious Diseases and Chronic Viral Illness Service, McGill University Health Centre, Montréal, QC, Canada.; Centre for Outcomes Research and Evaluation, Research Institute of the McGill University Health Centre, Montréal, QC, Canada.; Department of Family Medicine, McGill University Health Centre, Montréal, QC, Canada.<br /><searchLink fieldCode="AU" term="%22Costiniuk+CT%22">Costiniuk CT</searchLink>; Infectious Diseases and Immunity in Global Health Program, Research Institute, McGill University Health Centre, Montréal, QC, Canada.; Department of Medicine, Division of Infectious Diseases and Chronic Viral Illness Service, McGill University Health Centre, Montréal, QC, Canada.<br /><searchLink fieldCode="AU" term="%22Routy+B%22">Routy B</searchLink>; Centre de Recherche du Centre Hospitalier de L'Université de Montréal, Montreal, QC, Canada.; Hemato-oncology division, Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, QC, Canada.<br /><searchLink fieldCode="AU" term="%22Silverman+MS%22">Silverman MS</searchLink>; Department of Medicine, Division of Infectious Diseases, Western University, London, Ontario, Canada.; Lawson Research Institute, St Joseph's Health Care, London, Ontario, Canada.; Division of Infectious Diseases, St Joseph's Health Care, London, ON, Canada.<br /><searchLink fieldCode="AU" term="%22Routy+JP%22">Routy JP</searchLink>; Infectious Diseases and Immunity in Global Health Program, Research Institute, McGill University Health Centre, Montréal, QC, Canada. jean-pierre.routy@mcgill.ca.; Department of Medicine, Division of Infectious Diseases and Chronic Viral Illness Service, McGill University Health Centre, Montréal, QC, Canada. jean-pierre.routy@mcgill.ca.; Division of Hematology, McGill University Health Centre, Montréal, QC, Canada. jean-pierre.routy@mcgill.ca.
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