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CompletedNCT04471116Updated Jul 16, 2020

Influence of Probiotics on the Vaginal Microbiota

An interventional study of OMNi-BiOTiC® FLORA plus+ in Vaginal Microbiome, sponsored by Kinderwunsch Institut GmbH. Completed at 1 site in Austria. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2020-07-16.

Sponsored by Kinderwunsch Institut GmbH · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 2 years 3 months after the study started (first participant enrolled Mar 2018, registered Jul 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

Read the 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).

02

Conditions studied

  • Vaginal Microbiome

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Keywords

  • infertility
  • dysbiosis
  • probiotics
  • Lactobacillus
  • microbiome
03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's enrollment of 80 is below the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Kinderwunsch Institut GmbH is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • patients with primary or secondary infertility
  • age between 18 and 40
  • signed informed consent
  • BMI between 19 and 29.9

Exclusion criteria

Exclusion Criteria:

  • Patients with severe, acute and / or chronic diseases
  • obesity
  • hirsutism
  • current intake of antibiotics
  • State after hysterectomy
  • Simultaneous use of other probiotics
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • Active comparator
    Therapy group

    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

    Dietary Supplement: OMNi-BiOTiC® FLORA plus+

  • No intervention
    Control group

    Patients in the control group received no additional medication.

Interventions

  • Dietary supplementOMNi-BiOTiC® FLORA plus+

    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

06

What researchers measure

Primary outcomes

  1. vaginal microbiome

    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

    Time frame: 1 month

07

Study locations

1 site
  • Das Kinderwunsch Institut Schenk GmbH
    Dobl, Styria 8143, Austria
08

References and documents

Publications

  • Inhorn MC, Patrizio P. Infertility around the globe: new thinking on gender, reproductive technologies and global movements in the 21st century. Hum Reprod Update. 2015 Jul-Aug;21(4):411-26. doi: 10.1093/humupd/dmv016. Epub 2015 Mar 22. PubMed 25801630 ↗
  • Moreno I, Codoner FM, Vilella F, Valbuena D, Martinez-Blanch JF, Jimenez-Almazan J, Alonso R, Alama P, Remohi J, Pellicer A, Ramon D, Simon C. Evidence that the endometrial microbiota has an effect on implantation success or failure. Am J Obstet Gynecol. 2016 Dec;215(6):684-703. doi: 10.1016/j.ajog.2016.09.075. Epub 2016 Oct 4. PubMed 27717732 ↗
  • Miles SM, Hardy BL, Merrell DS. Investigation of the microbiota of the reproductive tract in women undergoing a total hysterectomy and bilateral salpingo-oopherectomy. Fertil Steril. 2017 Mar;107(3):813-820.e1. doi: 10.1016/j.fertnstert.2016.11.028. Epub 2017 Jan 6. PubMed 28069180 ↗
  • Haahr T, Jensen JS, Thomsen L, Duus L, Rygaard K, Humaidan P. Abnormal vaginal microbiota may be associated with poor reproductive outcomes: a prospective study in IVF patients. Hum Reprod. 2016 Apr;31(4):795-803. doi: 10.1093/humrep/dew026. Epub 2016 Feb 23. PubMed 26911864 ↗
  • van Oostrum N, De Sutter P, Meys J, Verstraelen H. Risks associated with bacterial vaginosis in infertility patients: a systematic review and meta-analysis. Hum Reprod. 2013 Jul;28(7):1809-15. doi: 10.1093/humrep/det096. Epub 2013 Mar 29. PubMed 23543384 ↗

Individual participant data

Plan to share: No — Data will be available within a publication of the study

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04471116
Lead sponsor
Kinderwunsch Institut GmbH
Collaborators
Institut AllergoSan
Responsible party
Sponsor
First posted
Jul 15, 2020
Start date
Mar 30, 2018
Primary completion
Jul 19, 2019
Completion
Nov 12, 2019
Last update
Jul 16, 2020

Study contacts

Michael Schenk, MD
principal investigator · Kinderwunsch Institut GmbH

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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