Bacterial VaginosisNCT03601429
Dietary Supplementation of Lactogyn in Women With Bacterial Vaginosis
A study testing Lactogyn in people with Bacterial Vaginosis, run by Vesale Pharmaceutica at 1 site in Ukraine.
Trial summary
The objective of the study is to determine clinical efficacy of Lactogyn (Lactobacillus Crispatus, L. brevis, L.acidophilus) in prevention of recurrent BV Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- Lactogyn
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 166 participants
- Where
- 1 siteUkraine
- Study dates
- 1 Jan 2018to 31 Aug 2018
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Informed consent form signed;
- Age: 18-45 years;
- Able to swallow capsules;
- Recent symptomatic BV successfully treated with metronidazole tablets in a dose of 500 mg 2 times daily for 7 days;
- Less than 48 hours after treatment of acute BV defined as three out of four Amsel criteria;
- Willing to communicate intimate history for the study purposes;
- Consent not to use spermicides for 4 months after starting TDC;
- Stated availability throughout the study period and a mobile phone.
Who cannot join
- Post-menopausal;
- Pregnancy or high risk of;
- Breast feeding;
- Currently active STD as determined by history, physical examination, and laboratory tests;
- Diabetes mellitus;
- Inflammatory bowel disease;
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- Alcohol or drug addiction as guessed by investigator;
- Absence of refrigerator;
- Known moderate to severe disease of any systems;
- Difficulty to comprehend study requirements as judged by physician;
- Any erosions, herpes like lesions, cervicitis during vaginal examination;
- Treatment of BV with other than metronidazole antibiotic;
- Use of any investigational drug within the previous 30 days;
- Use of drugs that suppress the immune system.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dietary Supplementation of Lactogyn in Women With Bacterial Vaginosis: a Randomized Clinical Trial
The objective of the study is to determine clinical efficacy of Lactogyn (Lactobacillus Crispatus, L. brevis, L.acidophilus) in prevention of recurrent BV
Read the detailed description
According to classification, this is a phase 2 randomized parallel group prospective controlled dietary study to evaluate efficacy of a dietary supplement, a combination of L. crispatus LMG S-29995, L. brevis, and L. acidophilus in women aged from 18 through 45 years suffering from rBV. The 2 phase of the study has been ascribed as there is no evidence that oral capsules with L. crispatus LMG S-29995, L. brevis, and L. acidophilus have a potential efficacy in rBV.
Qualifying women received a combination of the three probiotic strains with a half daily recommended dose of vitamin C or just vitamin C without probiotics, a control supplementation, via oral route of administration for up to 120 days. During the intake of active or control formulations, participants kept a structured 120-DSD, where they recorded test capsules intake, screen for symptoms of bacterial vaginosis, and food intolerance events.
Based on repeat physical examination with application of Amsel and Nugent criteria the main conclusions over the efficacy of probiotic strains were made.
- Conditions
- Bacterial Vaginosis
- Being tested
- Lactogyn, Placebo
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LactogynDietary supplement
capsules
PlaceboDietary supplement
capsules
| Study group | Role | What they receive |
|---|---|---|
| Lactogyn | Experimental | 1 capsule of Lactogyn 2 times daily for the first 7 days then 1 time daily for 4 months Receives: Dietary Supplement: Lactogyn |
| Placebo | Placebo comparator | 1 capsule of Placebo Comparator 2 times daily for the first 7 days then 1 time daily for 4 months Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in recurrence of BV during Lactogyn supplementation
Percent change in recurrence of BV during the 4 months of dietary supplementation
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Jan 2018
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial VaginosisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vesale Pharmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karl Richir, Study director, Vesale Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03601429
- Sponsor's protocol ID
- BV-SVG-A001
- Status last verified
- Apr 2019
- First submitted
- 4 Jul 2018
- Last updated
- 29 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Supplementation of Lactogyn in Women With Bacterial Vaginosis: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03601429
- Acronym / sponsor ID
- BV-SVG-A001
- Conditions
- Bacterial Vaginosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Vesale PharmaceuticaIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 26 Jul 2018 (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 objective of the study is to determine clinical efficacy of Lactogyn (Lactobacillus Crispatus, L. brevis, L.acidophilus) in prevention of recurrent BV
Detailed description
According to classification, this is a phase 2 randomized parallel group prospective controlled dietary study to evaluate efficacy of a dietary supplement, a combination of L. crispatus LMG S-29995, L. brevis, and L. acidophilus in women aged from 18 through 45 years suffering from rBV. The 2 phase of the study has been ascribed as there is no evidence that oral capsules with L. crispatus LMG S-29995, L. brevis, and L. acidophilus have a potential efficacy in rBV.
Qualifying women received a combination of the three probiotic strains with a half daily recommended dose of vitamin C or just vitamin C without probiotics, a control supplementation, via oral route of administration for up to 120 days. During the intake of active or control formulations, participants kept a structured 120-DSD, where they recorded test capsules intake, screen for symptoms of bacterial vaginosis, and food intolerance events.
Based on repeat physical examination with application of Amsel and Nugent criteria the main conclusions over the efficacy of probiotic strains were made.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactogyn | Experimental | Dietary Supplement: Lactogyn1 capsule of Lactogyn 2 times daily for the first 7 days then 1 time daily for 4 months |
| Placebo | Placebo comparator | Dietary Supplement: Placebo1 capsule of Placebo Comparator 2 times daily for the first 7 days then 1 time daily for 4 months |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Informed consent form signed;
- Age: 18-45 years;
- Able to swallow capsules;
- Recent symptomatic BV successfully treated with metronidazole tablets in a dose of 500 mg 2 times daily for 7 days;
- Less than 48 hours after treatment of acute BV defined as three out of four Amsel criteria;
Key exclusion criteria (14 listed)
- Post-menopausal;
- Pregnancy or high risk of;
- Breast feeding;
- Currently active STD as determined by history, physical examination, and laboratory tests;
- Diabetes mellitus;
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 |
|---|---|---|
| Lactogyncapsules | Dietary supplement | Lactogyn |
| Placebocapsules | Dietary supplement | Placebo |
Primary outcome
Percent change in recurrence of BV during Lactogyn supplementation
Time frame: 4 months
Percent change in recurrence of BV during the 4 months of dietary supplementation
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 29 Apr 2019.
- Individual participant dataSharing planned: No
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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.
Karl Richir study director
Vesale Pharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactogyn in people with Bacterial Vaginosis, run by Vesale Pharmaceutica at 1 site in Ukraine.
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 8 inclusion and 14 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 29 Apr 2019. 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 Ukraine. 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. Some participants in this study may receive a placebo. 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?
Percent change in recurrence of BV during Lactogyn supplementation (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2019.