Evidence map›Paper›PMID 28903767›Full record

Trial reportMicrobiome2017

Treatment of biofilms in bacterial vaginosis by an amphoteric tenside pessary-clinical study and microbiota analysis.

Cornelia Gottschick, Zhi-Luo Deng, Marius Vital, Clarissa Masur, Christoph Abels, Dietmar H Pieper, Manfred Rohde, Werner Mendling, Irene Wagner-Döbler

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

Trial report in Microbiome, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02687789 (A Prospective Parallel-design, Double-blind, Randomised, Controlled Investigation to Gain Clinical Experience and Further Knowledge About the Certified Medical Device Vaginal Suppository WO 3191 With Respect to Safety, Tolerability and Efficacy in the Post-Treatment of Bacterial Vaginosis), which is not on this map. Cited by 33 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 6 pooled it
3.8field-weighted citation impact, top 7% 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.

NCT02687789 nacompletednot on this map

A Prospective Parallel-design, Double-blind, Randomised, Controlled Investigation to Gain Clinical Experience and Further Knowledge About the Certified Medical Device Vaginal Suppository WO 3191 With Respect to Safety, Tolerability and Efficacy in the Post-Treatment of Bacterial Vaginosis

TypeinterventionalSponsorDr. August Wolff GmbH & Co. KG ArzneimittelRan2014 to 2015Enrolled43ConditionsVaginosis, BacterialArmsMedical Device: WO3191, Medical Device: Vagisan® Lactic Acid
3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 6 syntheses or guidelines pooled it, 66 citations in OpenAlex.

  1. Systems analysis of the HPV-microbiome-biofilm triad.Frontiers in cellular and infection microbiology · 2026
    Pooled it
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  5. Contribution ofFrontiers in cellular and infection microbiology · 2021
    Pooled it
  6. Pooled it
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  8. Trial
  9. Vaginal Microbiota and Pelvic Floor Dysfunction: Mechanistic Insights and Therapeutic Implications.Medical science monitor : international medical journal of experimental and clinical research · 2026
    Review
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  11. Article
  12. Review
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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

9 authors at 2 institutions in 1 country.

Cornelia GottschickResearch Group Microbial Communication, Helmholtz Centre for Infection Research, Inhoffenstr. 7, 38124, Braunschweig, Germany.
Zhi-Luo DengResearch Group Microbial Communication, Helmholtz Centre for Infection Research, Inhoffenstr. 7, 38124, Braunschweig, Germany.
Marius VitalResearch Group Microbial Interactions and Processes, Helmholtz Centre for Infection Research, Inhoffenstr. 7, 38124, Braunschweig, Germany.
Clarissa MasurDr. August Wolff GmbH & Co. KG Arzneimittel, Sudbrackstrasse 56, 33611, Bielefeld, Germany.
Christoph AbelsDr. August Wolff GmbH & Co. KG Arzneimittel, Sudbrackstrasse 56, 33611, Bielefeld, Germany.
Dietmar H PieperResearch Group Microbial Interactions and Processes, Helmholtz Centre for Infection Research, Inhoffenstr. 7, 38124, Braunschweig, Germany.
Manfred RohdeCentral Facility for Microscopy, Helmholtz Centre for Infection Research, Inhoffenstr. 7, 38124, Braunschweig, Germany.
Werner MendlingGerman Center for Infections in Gynecology and Obstetrics, Wuppertal, Germany.
Irene Wagner-DöblerResearch Group Microbial Communication, Helmholtz Centre for Infection Research, Inhoffenstr. 7, 38124, Braunschweig, Germany. Irene.Wagner-Doebler@helmholtz-hzi.de.
Helmholtz Centre for Infection Research · DEDr. August Wolff (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBacterial vaginosis (BV) is the most common vaginal syndrome among women in their reproductive years. It is associated with an increased risk of acquiring sexually transmitted infections and complications like preterm labor. BV is characterized by a high recurrence rate for which biofilms frequently found on vaginal epithelial cells may be a reason.

resultsHere, we report a controlled randomized clinical trial that tested the safety and effectiveness of a newly developed pessary containing an amphoteric tenside (WO3191) to disrupt biofilms after metronidazole treatment of BV. Pessaries containing lactic acid were provided to the control group, and microbial community composition was determined via Illumina sequencing of the V1-V2 region of the 16S rRNA gene. The most common community state type (CST) in healthy women was characterized by Lactobacillus crispatus. In BV, diversity was high with communities dominated by either Lactobacillus iners, Prevotella bivia, Sneathia amnii, or Prevotella amnii. Women with BV and proven biofilms had an increased abundance of Sneathia sanguinegens and a decreased abundance of Gardnerella vaginalis. Following metronidazole treatment, clinical symptoms cleared, Nugent score shifted to Lactobacillus dominance, biofilms disappeared, and diversity (Shannon index) was reduced in most women. Most of the patients responding to therapy exhibited a L. iners CST. Treatment with WO 3191 reduced biofilms but did not prevent recurrence. Women with high diversity after antibiotic treatment were more likely to develop recurrence.

conclusionsStabilizing the low diversity healthy flora by promoting growth of health-associated Lactobacillus sp. such as L. crispatus may be beneficial for long-term female health.

trial registrationClinicalTrials.gov NCT02687789.

Indexed as

AdultAnti-Bacterial AgentsBiofilmsFemaleGardnerella vaginalisHigh-Throughput Nucleotide SequencingHumansLactobacillusLactobacillus crispatusMetronidazoleMicrobiotaMiddle AgedPessariesPrevotellaRNA, Ribosomal, 16SSurface-Active AgentsAnti-Bacterial AgentsMetronidazoleRNA, Ribosomal, 16SSurface-Active AgentsAmphoteric tensideBacterial vaginosisBiofilmsVaginal microbiomeVaginal microbiota

Identifiers

PMID28903767
PMCPMC5598074
OpenAlexW2754762515

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.