Evidence map›Paper›PMID 34829967›Full record

ArticleBiomedicines2021

Clinical Effects of Oral Bacteriotherapy on Anal HPV Infection and Related Dysplasia in HIV-Positive MSM: Results from the "HPVinHIV" Trial.

Eugenio Nelson Cavallari, Giancarlo Ceccarelli, Letizia Santinelli, Giuseppe Pietro Innocenti, Gabriella De Girolamo, Cristian Borrazzo, Ornella Spagnolello, Carolina Scagnolari, Stefano Arcieri, Antonio Ciardi and 3 more

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Biomedicines, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04099433 (HPVinHIV), which is not on this map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 27% 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.

NCT04099433 naunknown statusnot on this map

HPVinHIV: Study of Anal HPV Infection in the Setting of HIV Infected Individuals

TypeinterventionalSponsorUniversity of Roma La SapienzaRan2019 to 2020Enrolled40ConditionsHIV, Anal DysplasiaArmsVivomixx, Placebo
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. Pooled it
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

13 authors at 2 institutions in 1 country.

Eugenio Nelson CavallariDepartment of Public Health and Infectious Diseases, "Sapienza" University of Rome, 00161 Rome, Italy.ORCID 0000-0002-6021-484X
Giancarlo CeccarelliDepartment of Public Health and Infectious Diseases, "Sapienza" University of Rome, 00161 Rome, Italy.ORCID 0000-0001-5921-3180
Letizia SantinelliDepartment of Public Health and Infectious Diseases, "Sapienza" University of Rome, 00161 Rome, Italy.ORCID 0000-0002-5621-058X
Giuseppe Pietro InnocentiDepartment of Public Health and Infectious Diseases, "Sapienza" University of Rome, 00161 Rome, Italy.ORCID 0000-0002-9975-9871
Gabriella De GirolamoDepartment of Public Health and Infectious Diseases, "Sapienza" University of Rome, 00161 Rome, Italy.
Cristian BorrazzoDepartment of Public Health and Infectious Diseases, "Sapienza" University of Rome, 00161 Rome, Italy.ORCID 0000-0002-2346-898X
Ornella SpagnolelloDepartment of Public Health and Infectious Diseases, "Sapienza" University of Rome, 00161 Rome, Italy.
Carolina ScagnolariDepartment of Molecular Medicine, "Sapienza" University of Rome, 00161 Rome, Italy.ORCID 0000-0003-1044-1478
Stefano ArcieriDepartment of Surgical Sciences, "Sapienza" University of Rome, 00161 Rome, Italy.
Antonio CiardiDepartment of Radiology, Oncology and Human Pathology, "Sapienza" University of Rome, 00161 Rome, Italy.
Alessandra PierangeliDepartment of Molecular Medicine, "Sapienza" University of Rome, 00161 Rome, Italy.ORCID 0000-0003-0633-360X
Claudio Maria MastroianniDepartment of Public Health and Infectious Diseases, "Sapienza" University of Rome, 00161 Rome, Italy.ORCID 0000-0002-1286-467X
Gabriella d'EttorreDepartment of Public Health and Infectious Diseases, "Sapienza" University of Rome, 00161 Rome, Italy.ORCID 0000-0002-3571-5677
Sapienza University of Rome · ITPoliclinico Umberto I · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAnal HPV infection, anal dysplasia and, ultimately, anal cancer are particularly common in HIV-infected men who have sex with men. Treatment of anal dysplasia, aiming to prevent evolution to squamous cell carcinoma of the anus, is currently limited to direct ablation and/or application of topical therapy. The aim of the present study is to investigate the effect of oral bacteriotherapy (Vivomixx® in EU, Visbiome® in USA) on anal HPV infection and HPV-related dysplasia of the anal canal in HIV-infected men who have sex with men.

methodsIn this randomized, placebo-controlled, quadruple-blinded trial (NCT04099433), HIV-positive men who have sex with men with anal HPV infection and HPV-related dysplasia were randomized to receive oral bacteriotherapy or placebo for 6 months. Anal HPV test, anal cytology and high resolution anoscopy with biopsies of anal lesions were performed at baseline and at the end of the study. Safety and tolerability of oral bacteriotherapy were also evaluated. Interim analysis results were presented.

results20 participants concluded the study procedures to date. No serious adverse events were reported. In respect to participants randomized to placebo, individuals in the experimental arm showed higher rate of anal dysplasia regression (

conclusionBeing an interim analysis, we limit ourselves to report the preliminary results of the current study. We refer the conclusions relating to the possible effectiveness of the intervention to the analysis of the definitive data.

Indexed as

anal dysplasiaHIVHPVMSMoral bacteriotherapyprobiotics

Identifiers

PMID34829967
PMCPMC8615833
OpenAlexW3216647387

What OpenQuestion holds

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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.