NCT04471116

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 15, 2020

Completed
Last Updated

July 16, 2020

Status Verified

July 1, 2020

Enrollment Period

1.3 years

First QC Date

July 10, 2020

Last Update Submit

July 14, 2020

Conditions

Vaginal Microbiome

Keywords

infertilitydysbiosisprobioticsLactobacillusmicrobiome

Outcome Measures

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

    1 month

Study Arms (2)

Therapy group

ACTIVE COMPARATOR

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+

Control group

NO INTERVENTION

Patients in the control group received no additional medication.

Interventions

OMNi-BiOTiC® FLORA plus+DIETARY_SUPPLEMENT

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

Therapy group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Das Kinderwunsch Institut Schenk GmbH

Dobl, Styria, 8143, Austria

Location

Related Publications (5)

  • 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.

    PMID: 25801630BACKGROUND

  • 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.

    PMID: 27717732BACKGROUND

  • 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.

    PMID: 28069180BACKGROUND

  • 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.

    PMID: 26911864BACKGROUND

  • 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.

    PMID: 23543384BACKGROUND

MeSH Terms

Conditions

InfertilityDysbiosis

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Schenk, MD

    Kinderwunsch Institut GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2020

First Posted

July 15, 2020

Study Start

March 30, 2018

Primary Completion

July 19, 2019

Study Completion

November 12, 2019

Last Updated

July 16, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Data will be available within a publication of the study

Locations

AU(1)