Influence of Probiotics on the Vaginal Microbiota
Condition: Vaginal Microbiome
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The study aims to assess the influence of a probiotic supplement (OMNi-BiOTiC® FLORA plus +)
      on the vaginal microbiome composition of women suffering from infertility.
    

Detailed description: 
      Infertility is a global phenomenon affecting around 186 millions of people worldwide. Many
      circumstances have been identified to cause infertile conditions, with age being one of the
      most limiting factors. However, in recent years the microbiome has gained importance in the
      treatment of infertility and is considered as another important player to improve success
      rate of reproductive medicine treatments like in-vitro-fertilization (IVF).

      Within the female reproductive tract the dominance of Lactobacilli is associated with a
      healthy vaginal microbial community in healthy reproductive-aged women. Since the microbiome
      has gained so much importance, its influence in IVF treatments is still controversially
      discussed. While some studies suggest a negative influence of vaginal dysbiosis on pregnancy
      rates a current meta-analysis showed no association between abnormal vaginal flora and
      conception rates following IVF treatment. One therapeutic approach is the administration of
      beneficial microorganisms (probiotics), mainly Lactobacillus species. The supplementation of
      exogenous lactobacilli strains has been suggested as cure for a dysbiotic vaginal flora to
      re-establish healthy conditions and improving female fertility health.

      Hence, in the present study we wanted to investigate the impact of 4 probiotic strains
      (Lactobacillus crispatus LBV88, Lactobacillus rhamnosus LBV96, Lactobacillus gasseri LBV150N
      and Lactobacillus jensenii LBV116) on the relative abundance of vaginal microbiata species in
      women suffering from infertility.

      80 infertile women suffering from infertility were included in the study within fertility
      treatment. 40 patients with IVF / ICSI were examined (20 with OMNi-BiOTiC® FLORA plus +, 20
      as a control) and 40 patients with IUI / VZO (20 with OMNi-BiOTiC® FLORA plus +, 20 as a
      control). The control patients were selected from the routine patient collective of the
      Kinderwunsch Institut Schenk GmbH and receive no treatment with probiotics or placebo.
      Patients in the therapy group took 1 sachet of OMNi-BiOTiC® FLORA plus + (= 2 g) dissolved in
      1/8 l of water once a day. Patients in the control group received no additional medication
      for routine treatment. Patients were randomized after inclusion in the study (block
      randomization).

      On day 20 in the pre-cycle of hormonal stimulation, a vaginal smear sample was taken from the
      patient. The investigator introduced a sterile swab (eSwabTM, Copan Diagnostics Inc., USA),
      and took material from the mucosal surface. The eSwab was transferred to a sterile Falcon
      tube, stored at -72 ° C and then handed over to the company biovis Diagnostik MVZ GmbH
      (Germany) for 16s rRNA gene analysis. On day 20 in the stimulated cycle or subsequent cycle
      of the fertility treatment, another vaginal smear sample was taken and also stored in a
      sterile Falcon tube at -72 ° C.

      The microbiota was determined using 16s rRNA gene analysis. The bacterial genomic DNA was
      isolated from the samples and the region V3-V4 was sequenced (Nextera XT, DNA Library
      Preparation Kit; Illumina MiSeq, Illumina, The Netherlands).
    

Intervention name(s): OMNi-BiOTiC® FLORA plus+
Intervention type(s): Dietary Supplement
Intervention description(s): OMNi-BiOTiC® FLORA plus + is a dietary supplement for the treatment of a disturbed vaginal flora (dysbiosis). The product combines probiotic bacterial strains with a special fiber mixture. The product contains the following strains: Lactobacillus crispatus LBV88, Lactobacillus rhamnosus LBV96, Lactobacillus gasseri LBV150N and Lactobacillus jensenii LBV116
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: infertility; dysbiosis; probiotics; Lactobacillus; microbiome