Vaginal MicrobiomeNCT04471116
Influence of Probiotics on the Vaginal Microbiota
A study testing OMNi-BiOTiC® FLORA plus+ in people with Vaginal Microbiome, run by Kinderwunsch Institut GmbH at 1 site in Austria.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Vaginal Microbiome
- What is being tested?
- OMNi-BiOTiC® FLORA plus+
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteAustria
- Study dates
- 30 Mar 2018to 12 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- patients with primary or secondary infertility
- age between 18 and 40
- signed informed consent
- BMI between 19 and 29.9
Who cannot join
- Patients with severe, acute and / or chronic diseases
- obesity
- hirsutism
- current intake of antibiotics
- State after hysterectomy
- Simultaneous use of other probiotics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of OMNi-BiOTiC® FLORA Plus+ on the Vaginal Microbiome of Patients Suffering From Infertility
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).
- Conditions
- Vaginal Microbiome
- Being tested
- OMNi-BiOTiC® FLORA plus+
- Keywords
- infertility, dysbiosis, probiotics, Lactobacillus, microbiome
- Medical subject headings
- Infertility, Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: OMNi-BiOTiC® FLORA plus+ |
| Control group | No intervention | Patients in the control group received no additional medication. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start30 Mar 2018
- Primary completion19 Jul 2019
- Study completion12 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Vaginal MicrobiomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kinderwunsch Institut GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Institut AllergoSan Pharma GmbH
- Responsible party
- Sponsor
- Investigators
- Michael Schenk, MD, Principal investigator, Kinderwunsch Institut GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04471116
- Sponsor's protocol ID
- FRED002
- Status last verified
- Jul 2020
- First submitted
- 10 Jul 2020
- Last updated
- 16 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available within a publication of the study
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 25801630Moreno 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 27717732Miles 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 28069180Haahr 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 26911864van 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of OMNi-BiOTiC® FLORA Plus+ on the Vaginal Microbiome of Patients Suffering From Infertility
- ClinicalTrials.gov ID
- NCT04471116
- Acronym / sponsor ID
- FRED002
- Conditions
- Vaginal Microbiome
- Keywords
- infertility, dysbiosis, probiotics, Lactobacillus, microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kinderwunsch Institut GmbHUniversity, hospital or other
- Collaborators
- Institut AllergoSan Pharma GmbH
- Study start
- 30 Mar 2018 (actual)
- Primary completion
- 19 Jul 2019 (actual)
- Study completion
- 12 Nov 2019 (actual)
- First posted
- 15 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapy group | Active comparator | Dietary Supplement: OMNi-BiOTiC® FLORA plus+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 |
| Control group | No intervention | –Patients in the control group received no additional medication. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- patients with primary or secondary infertility
- age between 18 and 40
- signed informed consent
- BMI between 19 and 29.9
Key exclusion criteria (6 listed)
- Patients with severe, acute and / or chronic diseases
- obesity
- hirsutism
- current intake of antibiotics
- State after hysterectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OMNi-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 | Dietary supplement | Therapy group |
Primary outcome
vaginal microbiome
Time frame: 1 month
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
- Background: PubMed 25801630Inhorn 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.
- Background: PubMed 27717732Moreno 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.
- Background: PubMed 28069180Miles 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.
- Background: PubMed 26911864Haahr 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.
- Background: PubMed 23543384van 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.
- Individual participant dataSharing planned: No. Data will be available within a publication of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Schenk, MD principal investigator
Kinderwunsch Institut GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OMNi-BiOTiC® FLORA plus+ in people with Vaginal Microbiome, run by Kinderwunsch Institut GmbH at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vaginal microbiome (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04471116, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2020.