Evidence map›Paper›PMID 41903526›Full record

Trial reportCell host & microbe2026

Vaginal microbiota impacts of a Lactobacillus crispatus live biotherapeutic and predictors of colonization in randomized controlled trial.

Seth M Bloom, Laura Symul, Joseph Elsherbini, Jiawu Xu, Salina Hussain, Johnathan Shih, Ashley Sango, Caroline M Mitchell, Anke Hemmerling, Thomas P Parks and 5 more

Abstract readRandomized Controlled TrialClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cell host & microbe, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. The Gut-Vagina Axis.Microorganisms · 2026
    Review
  3. Review
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

15 authors.

Seth M BloomRagon Institute of Mass General Brigham, MIT, and Harvard, Cambridge, MA 02139, USA; Infectious Diseases Division, Massachusetts General Hospital, Boston, MA 02114, USA; Harvard Medical School, Boston, MA 02115, USA.
Laura SymulInstitute of Statistics, Biostatistics and Actuarial Sciences, Louvain Institute of Data Analysis and Modelling, UCLouvain, 1348 Louvain-la-Neuve, Belgium.
Joseph ElsherbiniRagon Institute of Mass General Brigham, MIT, and Harvard, Cambridge, MA 02139, USA.
Jiawu XuRagon Institute of Mass General Brigham, MIT, and Harvard, Cambridge, MA 02139, USA.
Salina HussainRagon Institute of Mass General Brigham, MIT, and Harvard, Cambridge, MA 02139, USA.
Johnathan ShihRagon Institute of Mass General Brigham, MIT, and Harvard, Cambridge, MA 02139, USA.
Ashley SangoRagon Institute of Mass General Brigham, MIT, and Harvard, Cambridge, MA 02139, USA.
Caroline M MitchellRagon Institute of Mass General Brigham, MIT, and Harvard, Cambridge, MA 02139, USA; Harvard Medical School, Boston, MA 02115, USA; Department of Obstetrics & Gynecology, Massachusetts General Hospital, Boston, MA 02114, USA; Vincent Center for Reproductive Biology, Massachusetts General Hospital, Boston, MA 02114, USA.
Anke HemmerlingDepartment of Obstetrics, Gynecology, & Reproductive Sciences, University of California, San Francisco, San Francisco, CA 94158, USA.
Thomas P ParksOsel, Inc., Mountain View, CA 94043, USA.
Aditi KannanRagon Institute of Mass General Brigham, MIT, and Harvard, Cambridge, MA 02139, USA.
Fatima A HussainRagon Institute of Mass General Brigham, MIT, and Harvard, Cambridge, MA 02139, USA; Harvard Medical School, Boston, MA 02115, USA.
Craig R CohenDepartment of Obstetrics, Gynecology, & Reproductive Sciences, University of California, San Francisco, San Francisco, CA 94158, USA.
Susan P HolmesDepartment of Statistics, Stanford University, Stanford, CA 94305, USA.
Douglas S KwonRagon Institute of Mass General Brigham, MIT, and Harvard, Cambridge, MA 02139, USA; Infectious Diseases Division, Massachusetts General Hospital, Boston, MA 02114, USA; Harvard Medical School, Boston, MA 02115, USA. Electronic address: dkwon@mgh.harvard.edu.

Funding

Inflammation and the vaginal metagenome in HIV acquisitionR01AI111918 · NIAID · MASSACHUSETTS GENERAL HOSPITAL · PI KWON, DOUGLAS, VIRGIN, HERBERT W · 2014 to 2017
$2.5M
Identifying drivers of genital inflammation and HIV acquisition in women living in sub-Saharan AfricaR01AI184095 · NIAID · MASSACHUSETTS GENERAL HOSPITAL · PI Scott A. Handley, Douglas Kwon · 2024 to 2026
$2.4M
Mechanistic characterization of vaginal microbiome-metabolome associations and metabolite-mediated host inflammationK08AI171166 · NIAID · MASSACHUSETTS GENERAL HOSPITAL · PI SETH MICHAEL BLOOM · 2023 to 2026
$729k
Bill & Melinda Gates Foundation INV-033690NIAID NIH HHS K08 AI171166NIAID NIH HHS R01 AI111918NIAID NIH HHS R01 AI184095
6 · The paper itself

Abstract

Bacterial vaginosis (BV) affects >25% of women worldwide and often recurs after standard-of-care metronidazole (MTZ) treatment. LACTIN-V, a live biotherapeutic product (LBP) containing Lactobacillus crispatus strain CTV-05, significantly reduced recurrent BV in a phase 2b clinical trial, but efficacy was incomplete. Here, we characterize microbiota and immune effects using multi-omics and define correlates of treatment success. By week 12, an L. crispatus-dominant microbiota was achieved in 30% of LBP recipients compared with 9% of placebo recipients (benefit ratio: 3.31; p < 0.005). This is primarily due to CTV-05, but native L. crispatus strains are also present and increase over time. Inflammatory cytokines decrease in both arms after MTZ but return to baseline in placebo recipients. Successful L. crispatus colonization is associated with pre-MTZ microbiota, baseline inflammatory profiles, post-MTZ bacterial load, and clinical and behavioral variables. These findings elucidate LBP microbiota effects and identify predictors of treatment success, informing improved intervention strategies to advance women's health.

Indexed as

Lactobacillus crispatusMicrobiotaProbioticsVaginaVaginosis, BacterialBacterial LoadCytokinesFemaleHumansMetronidazoleMultiomicsTreatment OutcomeCytokinesMetronidazolebacterial vaginosisLactobacilluslive biotherapeutic productvaginal microbiomewomen’s health

Identifiers

PMID41903526
PMCPMC13525762

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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 Socratic graph.