Bacterial VaginosisNCT01993524
Supplementation of Standard Antibiotic Therapy With Oral Probiotics for Bacterial Vaginosis
A study testing probiotic in people with Bacterial Vaginosis and Bacterial Vaginitis, run by IBSS Biomed S.A..
Trial summary
The purpose of this study was to determine whether supplementation of standard antibiotic therapy with oral probiotic preparation prOVag containing lactic acid bacteria influences recurrence of bacterial vaginosis/vaginitis. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Bacterial Vaginosis, Bacterial Vaginitis
- What is being tested?
- probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 594 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Feb 2012
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Informed Consent Form
- Subjects aged more than or equal 18 and less than or equal 50 years
- Women of the Caucasian race
- Regularly menstruating premenopausal women (normal menstrual function (Eumenorrhoea) shall mean regular menstrual bleeding pattern every 28 plus/minus 10 days)
- No irregularities identified in gynaecological examination (no pathology of reproductive organs, such as myomas, ovarian cysts)
- Susceptibility to recurrent vaginitis and/or urinary tract infections, as well as bacterial vaginitis confirmed at visit I
Who cannot join
- Subjects aged less than 18 and more than 50 years
- Hypersensitivity to any ingredient of the investigational product, metronidazole or antibiotic(s).
- Bleeding from genital tract of unknown aetiology
- Pregnancy
- Breastfeeding
- Congenital and acquired immunodeficiencies
Show all 18Show fewer
- Diabetes
- Mental illness
- Neoplastic disease
- Application of mechanical contraceptives, such as: diaphragms, intrauterine contraceptive insert (except for Mirena intrauterine device)
- Application of NuvaRing hormonal contraceptive vaginal ring
- Application of hormonal preparations, such as: Vagifem, Ovestin and vaginal estrogens in reproductive period
- Application of another oral and/or vaginal probiotic at Subject qualification to the Study
- Participation in another clinical study / less than thirty-day interval from the last clinical study
- Mycotic vaginitis
- Antibiotic therapy for other reasons
- Pathology of reproductive organs (myomas, ovarian cysts, etc.)
- Scheduled surgery or hospitalization
About this study
Official title: Efficacy and Safety Assessment of prOVag Dietary Supplement in Recurrent Bacterial Vaginitis. Multi-centre, Randomized, Double-blind, Placebo-controlled Clinical Study.
The purpose of this study was to determine whether supplementation of standard antibiotic therapy with oral probiotic preparation prOVag containing lactic acid bacteria influences recurrence of bacterial vaginosis/vaginitis.
Read the detailed description
Bacterial vaginosis is the most common vaginal infection in women of reproductive age. This condition is caused by an overgrowth of anaerobic bacteria with concomitant reductions in Lactobacillus populations in the vagina, i.e. disruption of the vaginal microbiota. Aerobic vaginitis is related to the suppression of lactobacilli by various aerobic bacteria, mostly originating from the anal microbiota.
Previous open-label study confirmed that probiotic strains - Lactobacillus fermentum 57A, Lactobacillus plantarum 57B, and Lactobacillus gasseri 57C given orally to women with intermediate/abnormal vaginal flora and no clinical symptoms had the ability to colonize rectum and vagina and contributed to the maintenance of pH level and Nugent score. The colonisation of women with tested strains had been confirmed by microbiological and molecular methods.
The purpose of this multicentre, randomized study was to investigate whether the use of a probiotic preparation containing Lactobacillus fermentum 57A, Lactobacillus plantarum 57B, and Lactobacillus gasseri 57C together with standard treatment for bacterial vaginosis/vaginitis could reduce the recurrence rates of these conditions, as assessed using clinical and microbiological criteria, in comparison with standard treatment alone. The study took place between March 2009 and February 2012 in nine private out-patient gynaecological clinics in the Krakow area and Katowice (Silesia) in Poland. It was conducted in accordance with the original protocol and according to ICH-GCP requirements. The duration of subject's participation in the trial was approximately 5-6 months (follow-up visit included). As the trial did not concern medicinal product but the foodstuff (dietary supplement) it did not require Authority approval but was only subject to relevant Ethics Committee approval.
Women with history of recurrent bacterial vaginosis/vaginitis, aged 18 - 50 years, who complied with inclusion and exclusion criteria and who signed informed consent form were enrolled and randomized into one of the study groups.
Efficacy parameters were based on the evaluation of clinical symptoms during gynaecological examinations, as well as the determination of vaginal pH, Nugent score, total Lactobacillus counts and presence/numbers of vaginal pathogens in cultures from vaginal swabs collected at each visit. Data obtained at the third-fifth visits were compared with those obtained at the first visit. Clinical samples were transported to central laboratory for further analysis.
Safety parameters were analysed using information recorded in 'patient's diaries' throughout the study period, as well as the investigator's assessments at each visit.
- Conditions
- Bacterial Vaginosis, Bacterial Vaginitis
- Being tested
- probiotic, 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.
probioticDietary supplement
antibiotic plus probiotic
placeboOther
antibiotic plus placebo
| Study group | Role | What they receive |
|---|---|---|
| probiotic | Experimental | At I visit standard treatment(500mg oral metronidazole twice daily for 7 days) and probiotic twice daily for 10 days. At II visit, participants were checked for signs of vaginal infection; if they were still present they were given a targeted antibiotic according to the microbiological analysis. Antibiotic was taken together with probiotic twice daily for 10 days. Participants showing positive response to metronidazole treatment on the II visit were given only the probiotic once daily for 10 days in the peri-menstrual period for the next 3 months. Participants with targeted antibiotic were to come to the visit IIbis, and if treatment was successful they were to proceed for the next 3 months in the same manner as those successfully treated with metronidazole, as described above. Receives: Dietary Supplement: probiotic |
| placebo | Placebo comparator | At I visit standard treatment (500mg oral metronidazole twice daily for 7 days) and placebo twice daily for 10 days. At the II visit, participants were checked for signs of vaginal infection; if they were present they were given a targeted antibiotic according to the microbiological analysis. Antibiotic was taken together with placebo twice daily for 10 days. Participants showing positive responses to metronidazole on the II visit were given only placebo once daily for 10 days in the peri-menstrual period for the next 3 months. Participants with targeted antibiotic were to come to the visit IIbis, and if treatment was successful they were to proceed for the next 3 months in the same manner as those successfully treated with metronidazole, as described above. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced probability of recurrent bacterial vaginosis/vaginitis.
Recurrence of bacterial vaginosis/vaginitis at the third-fifth visits was considered to be the study endpoint (participant's withdrawal). The reduced probability of recurrent bacterial vaginal infection, confirmed by clinical and/or microbiological symptoms, was the parameter used to assess primary efficacy.
Measured: assesed on visits III-V (assesed monthly within three months)
Secondary outcomes (4)
Change in vaginal pH level.
Determination of pH level of vaginal discharge using indicator paper at each visit, comparison of the test outcome with the test result at Visit I.
Measured: assesed monthly within five-six months
Change in Nugent score level.
Assessment according to the Nugent score at each visit; comparison of the outcomes with the assessment at Visit I.
Measured: assesed monthly within five-six months
Change in total Lactobacillus counts a in cultures from vaginal swabs.
Total count of Lactobacillus bacteria in vaginal flora in material collected at each visit.Data obtained at the third-fifth visits were compared with those obtained at the first visit.
Measured: assesed monthly within five-six months
The time to bacterial vaginosis/vaginitis recurrence
The time to bacterial vaginosis/vaginitis recurrence was measured from the visit on which a participant showed no symptoms: the second visit for participants on standard metronidazole treatment and the second visit bis for participants treated with metronidazole and targeted antibiotics.
Measured: assesed on visits III-V (assesed monthly within three months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startMar 2009
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 594 participants (actual)
Sponsor and investigators
- Lead sponsor
- IBSS Biomed S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zbigniew Chelmicki, MD, PhD, Principal investigator, "Polis CLINIC" Prywatna Opieka Lekarska Specjalistyczna Sp. z o.o, ul. 1-go Maja 88, 40-240 Katowice, PolandAleksandra M Cichonska, PhD, Study director, IBSS Biomed S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01993524
- Sponsor's protocol ID
- PB-DM/SBK-prOVag2-01/08
- Status last verified
- Nov 2013
- First submitted
- 29 Oct 2013
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Heczko PB, Tomusiak A, Adamski P, Jakimiuk AJ, Stefanski G, Mikolajczyk-Cichonska A, Suda-Szczurek M, Strus M. Supplementation of standard antibiotic therapy with oral probiotics for bacterial vaginosis and aerobic vaginitis: a randomised, double-blind, placebo-controlled trial. BMC Womens Health. 2015 Dec 3;15:115. doi: 10.1186/s12905-015-0246-6.
PubMed 26635090
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Assessment of prOVag Dietary Supplement in Recurrent Bacterial Vaginitis. Multi-centre, Randomized, Double-blind, Placebo-controlled Clinical Study.
- ClinicalTrials.gov ID
- NCT01993524
- Acronym / sponsor ID
- PB-DM/SBK-prOVag2-01/08
- Conditions
- Bacterial Vaginosis, Bacterial Vaginitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 594 participants (actual)
- Lead sponsor
- IBSS Biomed S.A.Industry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 25 Nov 2013 (estimated)
- 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 purpose of this study was to determine whether supplementation of standard antibiotic therapy with oral probiotic preparation prOVag containing lactic acid bacteria influences recurrence of bacterial vaginosis/vaginitis.
Detailed description
Bacterial vaginosis is the most common vaginal infection in women of reproductive age. This condition is caused by an overgrowth of anaerobic bacteria with concomitant reductions in Lactobacillus populations in the vagina, i.e. disruption of the vaginal microbiota. Aerobic vaginitis is related to the suppression of lactobacilli by various aerobic bacteria, mostly originating from the anal microbiota.
Previous open-label study confirmed that probiotic strains - Lactobacillus fermentum 57A, Lactobacillus plantarum 57B, and Lactobacillus gasseri 57C given orally to women with intermediate/abnormal vaginal flora and no clinical symptoms had the ability to colonize rectum and vagina and contributed to the maintenance of pH level and Nugent score. The colonisation of women with tested strains had been confirmed by microbiological and molecular methods.
The purpose of this multicentre, randomized study was to investigate whether the use of a probiotic preparation containing Lactobacillus fermentum 57A, Lactobacillus plantarum 57B, and Lactobacillus gasseri 57C together with standard treatment for bacterial vaginosis/vaginitis could reduce the recurrence rates of these conditions, as assessed using clinical and microbiological criteria, in comparison with standard treatment alone. The study took place between March 2009 and February 2012 in nine private out-patient gynaecological clinics in the Krakow area and Katowice (Silesia) in Poland. It was conducted in accordance with the original protocol and according to ICH-GCP requirements. The duration of subject's participation in the trial was approximately 5-6 months (follow-up visit included). As the trial did not concern medicinal product but the foodstuff (dietary supplement) it did not require Authority approval but was only subject to relevant Ethics Committee approval.
Women with history of recurrent bacterial vaginosis/vaginitis, aged 18 - 50 years, who complied with inclusion and exclusion criteria and who signed informed consent form were enrolled and randomized into one of the study groups.
Efficacy parameters were based on the evaluation of clinical symptoms during gynaecological examinations, as well as the determination of vaginal pH, Nugent score, total Lactobacillus counts and presence/numbers of vaginal pathogens in cultures from vaginal swabs collected at each visit. Data obtained at the third-fifth visits were compared with those obtained at the first visit. Clinical samples were transported to central laboratory for further analysis.
Safety parameters were analysed using information recorded in 'patient's diaries' throughout the study period, as well as the investigator's assessments at each visit.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| probiotic | Experimental | Dietary Supplement: probioticAt I visit standard treatment(500mg oral metronidazole twice daily for 7 days) and probiotic twice daily for 10 days. At II visit, participants were checked for signs of vaginal infection; if they were still present they were given a targeted antibiotic according to the microbiological analysis. Antibiotic was taken together with probiotic twice daily for 10 days. Participants showing positive response to metronidazole treatment on the II visit were given only the probiotic once daily for 10 days in the peri-menstrual period for the next 3 months. Participants with targeted antibiotic were to come to the visit IIbis, and if treatment was successful they were to proceed for the next 3 months in the same manner as those successfully treated with metronidazole, as described above. |
| placebo | Placebo comparator | Other: placeboAt I visit standard treatment (500mg oral metronidazole twice daily for 7 days) and placebo twice daily for 10 days. At the II visit, participants were checked for signs of vaginal infection; if they were present they were given a targeted antibiotic according to the microbiological analysis. Antibiotic was taken together with placebo twice daily for 10 days. Participants showing positive responses to metronidazole on the II visit were given only placebo once daily for 10 days in the peri-menstrual period for the next 3 months. Participants with targeted antibiotic were to come to the visit IIbis, and if treatment was successful they were to proceed for the next 3 months in the same manner as those successfully treated with metronidazole, as described above. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Informed Consent Form
- Subjects aged more than or equal 18 and less than or equal 50 years
- Women of the Caucasian race
- Regularly menstruating premenopausal women (normal menstrual function (Eumenorrhoea) shall mean regular menstrual bleeding pattern every 28 plus/minus 10 days)
- No irregularities identified in gynaecological examination (no pathology of reproductive organs, such as myomas, ovarian cysts)
Key exclusion criteria (18 listed)
- Subjects aged less than 18 and more than 50 years
- Hypersensitivity to any ingredient of the investigational product, metronidazole or antibiotic(s).
- Bleeding from genital tract of unknown aetiology
- Pregnancy
- Breastfeeding
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 |
|---|---|---|
| probioticantibiotic plus probiotic | Dietary supplement | probiotic |
| placeboantibiotic plus placebo | Other | placebo |
Primary outcome
Reduced probability of recurrent bacterial vaginosis/vaginitis.
Time frame: assesed on visits III-V (assesed monthly within three months)
Recurrence of bacterial vaginosis/vaginitis at the third-fifth visits was considered to be the study endpoint (participant's withdrawal). The reduced probability of recurrent bacterial vaginal infection, confirmed by clinical and/or microbiological symptoms, was the parameter used to assess primary efficacy.
4 secondary outcomes
Change in vaginal pH level.
Time frame: assesed monthly within five-six months
Change in Nugent score level.
Time frame: assesed monthly within five-six months
Change in total Lactobacillus counts a in cultures from vaginal swabs.
Time frame: assesed monthly within five-six months
The time to bacterial vaginosis/vaginitis recurrence
Time frame: assesed on visits III-V (assesed monthly within three months)
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 25 Nov 2013.
- Derived from this study: PubMed 26635090Heczko PB, Tomusiak A, Adamski P, Jakimiuk AJ, Stefanski G, Mikolajczyk-Cichonska A, Suda-Szczurek M, Strus M. Supplementation of standard antibiotic therapy with oral probiotics for bacterial vaginosis and aerobic vaginitis: a randomised, double-blind, placebo-controlled trial. BMC Womens Health. 2015 Dec 3;15:115. doi: 10.1186/s12905-015-0246-6.
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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.
Zbigniew Chelmicki, MD, PhD principal investigator
"Polis CLINIC" Prywatna Opieka Lekarska Specjalistyczna Sp. z o.o, ul. 1-go Maja 88, 40-240 Katowice, Poland
Aleksandra M Cichonska, PhD study director
IBSS Biomed S.A.
Questions about this trial
What is this clinical trial studying?
A study testing probiotic in people with Bacterial Vaginosis and Bacterial Vaginitis, run by IBSS Biomed S.A..
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 6 inclusion and 18 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 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Reduced probability of recurrent bacterial vaginosis/vaginitis. (time frame: assesed on visits III-V (assesed monthly within three months)). 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 NCT01993524, which also lists 1 linked publication.
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 25 Nov 2013.