Fecal microbiota transplantation in HIV: A pilot placebo-controlled study

Sergio Serrano-Villar*, Alba Talavera-Rodríguez, María José Gosalbes, Nadia Madrid, José A. Pérez-Molina, Ryan J. Elliott, Beatriz Navia, Val F. Lanza, Alejandro Vallejo, Majdi Osman, Fernando Dronda, Shrish Budree, Javier Zamora, Carolina Gutiérrez, Mónica Manzano, María Jesús Vivancos, Raquel Ron, Javier Martínez-Sanz, Sabina Herrera, Uxua AnsaAndrés Moya, Santiago Moreno

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

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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.

Original languageEnglish
Article number1139
JournalNature Communications
Issue number1
Publication statusPublished - 18 Feb 2021

Bibliographical note

Funding Information:
We thank all the study participants who contributed to this work, subjects who helped to disseminate the crowdfunding campaign to raise funds for this project, those who altruistically contributed with donations, as well as the clinical research staff who made this research possible. We especially thank Laura Luna and María Helena Álvarez for their technical support throughout the study. This work was supported by the Instituto de Salud Carlos III (Plan Estatal de I + D + i 2013–2016, project PI18/00154, a Gilead Fellowship (GLD16-00030), the SPANISH AIDS Research Network RD16/0025/ 0001project), and co-financed by the European Development Regional Fund ‘A way to achieve Europe’ (ERDF). The present investigation was also funded by the Instituto de Salud Carlos III and the Fundación Asociación Española contra el Cáncer within the ERANET TRANSCAN-2 program, grant number AC17/00022, a crowdfunding project from the precipita platform of the Fundación Española para la Ciencia y la Tecnología (FECYT) and a restricted grant from Finch Therapeutics. The SEIMC-GESIDA Foundation supported this study with safety and data monitoring (GESIDA 9116). The funder of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication.

Funding Information:
Outside the submitted work, S.S.-V. reports personal fees from ViiV Healthcare, Janssen Cilag, Gilead Sciences, and MSD as well as non-financial support from ViiV Healthcare and Gilead Sciences and research grants from MSD and Gilead Sciences. J.M.-S. reports non-financial support from ViiV Healthcare, Gilead Sciences, and Jannsen Cilag. J.P. reports grants, personal fees and non-financial support from ViiV Healthcare; grants, personal fees, and non-financial support from Gilead Sciences; grants, personal fees, and non-financial support from Janssen Cilag; personal fees from MSD; and personal fees from Abbvie. F.D. reports personal fees from Gilead. J.M.S. reports personal fees from ViiV Healthcare, Janssen Cilag, and Gilead Sciences. MJ.V. reports personal fees from Gilead Sciences, non-financial support from ViiV Healthcare, and Gilead Sciences, and grants from ViiV Healthcare. S.M. reports personal fees and non-financial from ViiV Healthcare, Janssen, Gilead Sciences, and MSD, as well as grants from MSD, ViiV Healthcare, and Gilead Sciences. S.B. and M.O. work for OpenBiome. R.E. was an employee at OpenBiome during the conduct of this study. A.T.-R., M.J.G., N.M., B.N., V.L., A.V., J.Z., C.G., M.M., R.R., S.H., U.A., and A.M. report no conflicts of interest.

Publisher Copyright:
© 2021, The Author(s).

ASJC Scopus subject areas

  • Chemistry(all)
  • Biochemistry, Genetics and Molecular Biology(all)
  • Physics and Astronomy(all)


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