Evidence map›Paper›PMID 21992977›Full record

Trial reportSexually transmitted diseases2011

Effects of bacterial vaginosis-associated bacteria and sexual intercourse on vaginal colonization with the probiotic Lactobacillus crispatus CTV-05.

Benjamin M Ngugi, Anke Hemmerling, Elizabeth A Bukusi, Gideon Kikuvi, Joseph Gikunju, Stephen Shiboski, David N Fredricks, Craig R Cohen

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

Trial report in Sexually transmitted diseases, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05022212 (Phase 2 Placebo-controlled Randomized Trial of LACTIN-V), which is not on this map. Cited by 38 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 1 pooled it
2.2field-weighted citation impact, top 14% 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.

NCT05022212 phase2completednot on this mapstarted 2021, after this paper: background citation

Phase 2 Placebo-controlled Randomized Trial of LACTIN-V (Lactobacillus Crispatus CTV-05) Among Women at High Risk of HIV Acquisition in Durban, South Africa

TypeinterventionalSponsorUniversity of California, San FranciscoRan2021 to 2023Enrolled45ConditionsBacterial Vaginosis, HIV InfectionsArmsLACTIN-V, Placebo
3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 1 synthesis or guideline pooled it, 68 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Review
  7. Review
  8. Review
  9. Review
  10. Bacterial vaginosis.Nature reviews. Disease primers · 2025
    Review
  11. Review
  12. Article
  13. Review
  14. Review
  15. Article
  16. Fabrication and characterization of bioprints with Lactobacillus crispatus for vaginal application.Journal of controlled release : official journal of the Controlled Release Society · 2023
    Article
  17. Article
  18. Article
  19. Article
  20. 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

8 authors at 4 institutions in 2 countries.

Benjamin M NgugiCentre for Microbiology Research, Kenya Medical Research Institute (KEMRI), Nairobi, Kenya. bm_ngugi@yahoo.com
Anke Hemmerling
Elizabeth A Bukusi
Gideon Kikuvi
Joseph Gikunju
Stephen Shiboski
David N Fredricks
Craig R Cohen
Jomo Kenyatta University of Agriculture and Technology · KEUniversity of California, San Francisco · USKenya Medical Research Institute · KEUniversity of Washington · US

Funding

UCSF CLINICAL AND TRANSLATIONAL SCIENCE INSTITUTEUL1RR024131 · NCRR · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI JOHNSTON, S. CLAIBORNE · 2006 to 2011
$111.2M
Virology CoreP30AI027763 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI STEVEN Grant DEEKS · 1988 to 2026
$93.6M
KEMRI-UCSF Sexually Transmitted Infections Training ProgramD43TW007388 · FIC · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI COHEN, CRAIG R · 2005 to 2009
$736k
FIC NIH HHS D43 TW007388NCRR NIH HHS UL1 RR024131NIAID NIH HHS P30 AI027763
6 · The paper itself

Abstract

objectiveSeveral fastidious bacteria have been associated with bacterial vaginosis (BV), but their role in lactobacilli recolonization failure is unknown. We studied the effect of 7 BV-associated bacterial species and 2 Lactobacillus species on vaginal colonization with Lactobacillus crispatus CTV-05 (LACTIN-V).

methodsTwenty-four women with BV were given a 5-day course of metronidazole vaginal gel and then randomized 3:1 to receive either LACTIN-V or placebo applied vaginally once daily for 5 initial consecutive days, followed by a weekly application over 2 weeks. Vaginal swabs for L. crispatus CTV-05 culture and 9 bacterium-specific 16S rRNA gene quantitative polymerase chain reaction assays were analyzed on several study visits for the 18 women receiving LACTIN-V.

resultsVaginal colonization with CTV-05 was achieved in 61% of the participants receiving LACTIN-V at either day 10 or day 28 visit and 44% at day 28. Participants not colonized with CTV-05 had generally higher median concentrations of BV-associated bacteria compared to those who colonized. Between enrollment and day 28, the median concentration of Gardnerella vaginalis minimally reduced from 10 to 10 16S rRNA gene copies per swab in women who colonized with CTV-05 but increased from 10 to 10 in those who failed to colonize (P = 0.19). Similarly, the median concentration of Atopobium spp. reduced from 10 16S rRNA gene copies per swab to below limit of detection in women who colonized with CTV-05, but increased from 10 to 10 in those who failed to colonize (P = 0.04). The presence of endogenous L. crispatus at enrollment was found to be significantly associated with a reduced odds of colonization with CTV-05 on day 28 (P = 0.003), and vaginal intercourse during the study significantly impaired successful CTV-05 colonization (P = 0.018).

conclusionVaginal concentration of certain BV-associated bacteria, vaginal intercourse during treatment, and the presence of endogenous L. crispatus at enrollment predict colonization with probiotic lactobacilli.

Indexed as

CoitusProbioticsAdolescentAdultAnti-Bacterial AgentsBacteriaDNA, BacterialFemaleGardnerella vaginalisHumansLactobacillusMetronidazolePolymerase Chain ReactionRNA, Ribosomal, 16STreatment OutcomeVaginaAnti-Bacterial AgentsDNA, BacterialMetronidazoleRNA, Ribosomal, 16S

Identifiers

PMID21992977
PMCPMC3193282
OpenAlexW2090620868

What OpenQuestion holds

Textmetadata
LicenceTDM
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.