Evidence map›Paper›PMID 26137971›Full record

Trial reportBMC infectious diseases2015

Vaginal colonisation by probiotic lactobacilli and clinical outcome in women conventionally treated for bacterial vaginosis and yeast infection.

Sonal Pendharkar, Erik Brandsborg, Lennart Hammarström, Harold Marcotte, Per-Göran Larsson

Registry-linked trialOpen access · goldAbstract readClinical Trial
In one paragraph

Trial report in BMC infectious diseases, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02295579 (Vaginal Colonization After Treatment With Lactobacillus in Women With BV or Candida Will That Increase the Cure Rate After Treatment With Clindamycin for BV and Flucnazole for Candida), which is not on this map. Cited by 43 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 1 pooled it
3.9field-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.

NCT02295579 completednot on this map

Vaginal Colonization After Treatment With Lactobacillus in Women With BV or Candida Will That Increase the Cure Rate After Treatment With Clindamycin for BV and Flucnazole for Candida

Typeobservational_patient_registrySponsorSkaraborg HospitalRan2014 to 2015Enrolled50ConditionsBacterial VaginosisArmslactobacillus (EcoVag)
3 · Its place in the literature

Who cites it

43 citing papers in PubMed, 1 synthesis or guideline pooled it, 94 citations in OpenAlex.

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  12. The impact of fluconazole use on the fungal and bacterial microbiomes in recurrent Vulvovaginal Candidiasis (RVVC): a pilot study of vaginal and gastrointestinal site interplay.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2025
    Article
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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

5 authors at 3 institutions in 2 countries.

Sonal PendharkarDivision of Clinical Immunology, Department of Laboratory Medicine, Karolinska Institutet at Karolinska University Hospital Huddinge, Stockholm, Sweden. snlsll@gmail.com.
Erik BrandsborgBifodan AS, Hundested, Denmark. erb@bifodan.com.
Lennart HammarströmDivision of Clinical Immunology, Department of Laboratory Medicine, Karolinska Institutet at Karolinska University Hospital Huddinge, Stockholm, Sweden. Lennart.Hammarstrom@ki.se.
Harold MarcotteDivision of Clinical Immunology, Department of Laboratory Medicine, Karolinska Institutet at Karolinska University Hospital Huddinge, Stockholm, Sweden. Harold.Marcotte@ki.se.
Per-Göran LarssonDepartment of Obstetrics and Gynaecology Kärnsjukhuset, Skaraborg hospital and University of Skövde, Skövde, Sweden. p-g.larsson@telia.com.
Karolinska University Hospital · SEBifodan (Denmark) · DKUniversity of Skövde · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe aim of this study was to investigate the colonisation by lactobacilli and clinical outcome in women with bacterial vaginosis (BV) and recurrent vulvovaginal candidiasis (R-VVC) receiving antibiotic or anti-fungal treatment in combination with the probiotic EcoVag® capsules.

methodsA total of 40 Scandinavian women diagnosed with BV or VVC on the basis of Amsel's criteria or clinical symptoms were consecutively recruited in two pilot open label clinical trials. In trial I, women with BV were treated with clindamycin and metronidazole followed by vaginal EcoVag® capsules, containing Lactobacillus rhamnosus DSM 14870 and Lactobacillus gasseri DSM 14869, for 5 consecutive days after each antibiotic treatment. In trial II, women were recruited in three groups as follows: women with BV receiving clindamycin and metronidazole treatment together with a prolonged administration of EcoVag® (10 consecutive days after each antibiotic treatment followed by weekly administration of capsules for next four months), women with R-VVC receiving extended fluconazole and EcoVag® treatment, and women receiving extended fluconazole treatments only. The difference in frequency of isolation of EcoVag® strains or other lactobacilli between groups was compared by Fisher's exact test.

resultsThe 6-month cure rate for BV was 50 % in trial I while both the 6- and 12-month cure rates were 67 % in trial II. The 6- and 12-month cure rates for VVC were 100 % and 89 % in women receiving fluconazole and EcoVag®, and 100 % and 70 % in women receiving fluconazole only. The frequency of isolation of any Lactobacillus species during the course of the study was associated with cure of BV in trial I and II, whereas the frequency of isolation of EcoVag® strains was significantly associated with the cure of BV in trial II only. As previously observed, a change in sexual partner was associated with relapse of BV with an Odds ratio of 77 (95 % CI: 2.665 to 2225).

conclusionsThe study suggests that the treatment with antibiotics or anti-fungal medication in combination with EcoVag® capsules provide long-term cure against BV and R-VVC as compared to previous reports.

trial registrationClinicalTrials.gov NCT02295579 . Registered November 20, 2014.

Indexed as

Carrier StateAdministration, IntravaginalAdultAnti-Bacterial AgentsAntifungal AgentsCandidiasis, VulvovaginalClindamycinDrug Therapy, CombinationFemaleFluconazoleHumansLactobacillusMetronidazoleMiddle AgedProbioticsTreatment OutcomeAnti-Bacterial AgentsAntifungal AgentsClindamycinFluconazoleMetronidazole

Identifiers

PMID26137971
PMCPMC4489123
OpenAlexW1517994472

What OpenQuestion holds

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LicenceCC BY
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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.