Evidence map›Paper›PMID 33602945›Full record

Trial reportNature communications2021

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 and 12 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Nature communications, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03008941 (A Phase I/II Randomized, Double-Blind, Placebo Controlled Study of Repeated Low-Dose Fecal Microbiota Restoration in HIV-Infected Subjects. The REFRESH Study), which is not on this map. Cited by 64 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
64citing papers in PubMed, 2 pooled it
4.5field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03008941 phase1 / phase2completednot on this map

A Phase I/II Randomized, Double-Blind, Placebo Controlled Study of Repeated Low-Dose Fecal Microbiota Restoration in HIV-Infected Subjects. The REFRESH Study

TypeinterventionalSponsorFundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalRan2017 to 2018Enrolled30ConditionsHIV InfectionArmsFMT, Placebo
3 · Its place in the literature

Who cites it

64 citing papers in PubMed, 2 syntheses or guidelines pooled it, 92 citations in OpenAlex.

  1. Efficacy of probiotics pretreatment inAnnals of medicine · 2025
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4 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors at 6 institutions in 3 countries.

Sergio Serrano-VillarDepartment of Infectious Diseases, Hospital Universitario Ramon y Cajal, and IRYCIS, Madrid, Spain. sergio.serrano@salud.madrid.org.ORCID 0000-0002-5447-3554
Alba Talavera-RodríguezBioinformatics Unit, Hospital Universitario Ramon y Cajal, IRYCIS, Madrid, Spain.
María José GosalbesArea of Genomics and Health, FISABIO-Salud Pública, Valencia, Spain.
Nadia MadridDepartment of Infectious Diseases, Hospital Universitario Ramon y Cajal, and IRYCIS, Madrid, Spain.
José A Pérez-MolinaDepartment of Infectious Diseases, Hospital Universitario Ramon y Cajal, and IRYCIS, Madrid, Spain.
Ryan J ElliottOpenBiome, Cambridge, MA, USA.ORCID 0000-0001-8053-4624
Beatriz NaviaDepartment of Nutrition, Facultad de Farmacia, Universidad Complutense, Madrid, Spain.
Val F LanzaBioinformatics Unit, Hospital Universitario Ramon y Cajal, IRYCIS, Madrid, Spain.
Alejandro VallejoDepartment of Infectious Diseases, Hospital Universitario Ramon y Cajal, and IRYCIS, Madrid, Spain.
Majdi OsmanOpenBiome, Cambridge, MA, USA.
Fernando DrondaDepartment of Infectious Diseases, Hospital Universitario Ramon y Cajal, and IRYCIS, Madrid, Spain.
Shrish BudreeOpenBiome, Cambridge, MA, USA.
Javier ZamoraBarts and the London School for Medicine and Dentistry. Queen Mary University of London, London, UK.
Carolina GutiérrezDepartment of Infectious Diseases, Hospital Universitario Ramon y Cajal, and IRYCIS, Madrid, Spain.
Mónica ManzanoDepartment of Nutrition, Facultad de Farmacia, Universidad Complutense, Madrid, Spain.ORCID 0000-0003-1697-1461
María Jesús VivancosDepartment of Infectious Diseases, Hospital Universitario Ramon y Cajal, and IRYCIS, Madrid, Spain.
Raquel RonDepartment of Infectious Diseases, Hospital Universitario Ramon y Cajal, and IRYCIS, Madrid, Spain.
Javier Martínez-SanzDepartment of Infectious Diseases, Hospital Universitario Ramon y Cajal, and IRYCIS, Madrid, Spain.
Sabina HerreraDepartment of Infectious Diseases, Hospital Universitario Ramon y Cajal, and IRYCIS, Madrid, Spain.
Uxua AnsaDepartment of Infectious Diseases, Hospital Universitario Ramon y Cajal, and IRYCIS, Madrid, Spain.
Andrés MoyaArea of Genomics and Health, FISABIO-Salud Pública, Valencia, Spain.ORCID 0000-0002-2867-1119
Santiago MorenoDepartment of Infectious Diseases, Hospital Universitario Ramon y Cajal, and IRYCIS, Madrid, Spain.
Instituto Ramón y Cajal de Investigación Sanitaria · ESOpenBiome · USUniversidad Complutense de Madrid · ESConsejo Superior de Investigaciones Científicas · ESFundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana · ESQueen Mary University of London · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

Fecal Microbiota TransplantationBiodiversityBiomarkersDiscriminant AnalysisGastrointestinal MicrobiomeHIV InfectionsHumansMaleMiddle AgedPhylogenyPilot ProjectsPlacebosTissue DonorsBiomarkersPlacebos

Identifiers

PMID33602945
PMCPMC7892558
OpenAlexW3130310492

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.