RT Journal Article T1 Fecal microbiota transplantation in HIV: A pilot placebo-controlled study A1 Serrano-Villar, Sergio A1 Talavera-Rodríguez, Alba A1 Gosalbes, María José A1 Madrid, Nadia A1 Pérez-Molina, José Antonio A1 Elliott, Ryan J A1 Navia Lombán, Beatriz A1 Lanza, Val F A1 Vallejo, Alejandro A1 Osman, Majdi A1 Dronda, Fernando A1 Budree, Shrish A1 Zamora, Javier A1 Gutiérrez, Carolina A1 Manzano, Mónica A1 Vivancos, María Jesús A1 Ron, Raquel A1 Martínez-Sanz, Javier A1 Herrera, Sabina A1 Ansa, Uxua A1 Moya, A A1 Moreno, Santiago AB Changes in the microbiota have been linked to persistent inflammation during treated HIV infection. In this pilot double-blind study, we study 30 HIV-infected subjects on antiretroviral therapy (ART) with a CD4/CD8 ratio < 1 randomized to either weekly fecal microbiota capsules or placebo for 8 weeks. Stool donors were rationally selected based on their microbiota signatures. We report that fecal microbiota transplantation (FMT) is safe, not related to severe adverse events, and attenuates HIV-associated dysbiosis. FMT elicits changes in gut microbiota structure, including significant increases in alpha diversity, and a mild and transient engraftment of donor’s microbiota during the treatment period. The greater engraftment seems to be achieved by recent antibiotic use before FMT. The Lachnospiraceae and Ruminococcaceae families, which are typically depleted in people with HIV, are the taxa more robustly engrafted across time-points. In exploratory analyses, we describe a significant amelioration in the FMT group in intestinal fatty acid-binding protein (IFABP), a biomarker of intestinal damage that independently predicts mortality. Gut microbiota manipulation using a non-invasive and safe strategy of FMT delivery is feasible and deserves further investigation. Trial number: NCT03008941. PB Springer Nature YR 2021 FD 2021-02-18 LK https://hdl.handle.net/20.500.14352/93106 UL https://hdl.handle.net/20.500.14352/93106 LA eng NO Serrano-Villar S, Talavera-Rodríguez A, Gosalbes MJ, Madrid N, Pérez-Molina JA, Elliott RJ, Navia B, Lanza VF, Vallejo A, Osman M, Dronda F, Budree S, Zamora J, Gutiérrez C, Manzano M, Vivancos MJ, Ron R, Martínez-Sanz J, Herrera S, Ansa U, Moya A, Moreno S. Fecal microbiota transplantation in HIV: A pilot placebo-controlled study. Nat Commun. 2021 Feb 18;12(1):1139. NO Instituto de Salud Carlos III NO SPANISH AIDS Research Network NO European Development Regional Fund ‘A way to achieve Europe’ (ERDF) NO Fundación Asociación Española contra el Cáncer NO Fundación Española para la Ciencia y la Tecnología(FECYT) NO Finch Therapeutics DS Docta Complutense RD 5 abr 2025