Evidence map›Paper›PMID 27324341›Full record

Trial reportCurrent microbiology2016

Impact of Probiotic SYNBIO(®) Administered by Vaginal Suppositories in Promoting Vaginal Health of Apparently Healthy Women.

Maria Cristina Verdenelli, Cinzia Cecchini, Maria Magdalena Coman, Stefania Silvi, Carla Orpianesi, Giuliana Coata, Alberto Cresci, Gian Carlo Di Renzo

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Current microbiology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 1 pooled it
–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

29 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Effect of Oral ProbioticNutrients · 2020
    Trial
  5. Article
  6. Review
  7. Review
  8. Article
  9. Article
  10. Biomolecule-Producing Probiotic BacteriumJournal of functional biomaterials · 2024
    Article
  11. Article
  12. Review
  13. Review
  14. Oral Intake of the Commercial Probiotic Blend SynbioJournal of clinical medicine · 2022
    Article
  15. Review
  16. Influence of Lacidophilin Vaginal Capsules plus rh-IFN-Evidence-based complementary and alternative medicine : eCAM · 2022
    Article
  17. Review
  18. Review
  19. Review
  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.

Maria Cristina VerdenelliSynbiotec S.r.l., Spin-off of UNICAM, Via Gentile III Da Varano, 62032, Camerino, Italy. cristina.verdenelli@unicam.it.
Cinzia CecchiniSynbiotec S.r.l., Spin-off of UNICAM, Via Gentile III Da Varano, 62032, Camerino, Italy.
Maria Magdalena ComanSynbiotec S.r.l., Spin-off of UNICAM, Via Gentile III Da Varano, 62032, Camerino, Italy.
Stefania SilviSynbiotec S.r.l., Spin-off of UNICAM, Via Gentile III Da Varano, 62032, Camerino, Italy.
Carla OrpianesiSynbiotec S.r.l., Spin-off of UNICAM, Via Gentile III Da Varano, 62032, Camerino, Italy.
Giuliana CoataDepartment of Obstetrics and Gynecology, University of Perugia, Perugia, Italy.
Alberto CresciSynbiotec S.r.l., Spin-off of UNICAM, Via Gentile III Da Varano, 62032, Camerino, Italy.
Gian Carlo Di RenzoDepartment of Obstetrics and Gynecology, University of Perugia, Perugia, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The purpose of this study was to investigate whether vaginal administration of probiotic Lactobacillus results in their colonization and persistence in the vagina and whether it promotes normalization and maintenance of pH and Nugent score. A single-arm, open-label controlled towards the baseline (pre-post) study including 35 apparently healthy women was conducted. Each woman was examined three times during the study. Women were instructed to receive daily for 7 days, the probiotic suppositories SYNBIO(®) gin (Lactobacillus rhamnosus IMC 501(®) and Lactobacillus paracasei IMC 502(®)). Vaginal swabs were collected during visit 1, 2, and 3 to determine the total lactobacilli count, the presence of the two administered bacteria, the measure of the pH, and the estimation of Nugent score. Evaluation of treatment tolerability was based on analysis of the type and occurrence of adverse events. The probiotic vaginal suppository was well tolerated and no side effects were reported. Intermediate Nugent score was registered in 40 % of women at visit 1 and these intermediate scores reverted to normal at day 7 (end of treatment) in 20 % of subjects. Administration of SYNBIO(®) gin contributed to a significant increase in the lactobacilli level at visit 2. Molecular typing revealed the presence of the two strains originating from SYNBIO(®) gin in 100 % of women at visit 2 and 34 % at visit 3. No significant changes were registered for pH between visits. The SYNBIO(®) gin product is safe for daily use in healthy women and it could be useful to restore and maintain a normal vaginal microbiota.

Indexed as

MicrobiotaAdolescentAdultFemaleHealthy VolunteersHumansHydrogen-Ion ConcentrationLactobacillusMiddle AgedProbioticsSuppositoriesVaginaWomen's HealthYoung AdultSuppositories

Identifiers

What OpenQuestion 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 OpenQuestion graph.