Bacterial Vaginosis (BV)NCT06659380
Probiotic Efficacy in Postmenopausal Women with Bacterial Vaginosis
A study testing Metronidazole + Floragyn® probiotic tablets (Lapi, Indonesia), Metronidazole + Cal95 and Floragyn® probiotic tablets (Lapi, Indonesia) in people with Bacterial Vaginosis (BV) and Menopause, run by Hasanuddin University at 1 site in Indonesia.
Trial summary
This study is a double-blind, randomized, controlled trial (RCT) aimed at evaluating the effects of Lactobacillus sp. probiotic administration on the vaginal microbiota changes in postmenopausal women with bacterial vaginosis and how its affect to immunology profile. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bacterial Vaginosis (BV), Menopause
- What is being tested?
- Metronidazole + Floragyn® probiotic tablets (Lapi, Indonesia), Metronidazole + Cal95 and Floragyn® probiotic tablets (Lapi, Indonesia)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteIndonesia
- Study dates
- 26 Jun 2024to 31 Dec 2024
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Postmenopausal with estradiol levels < 25 mg/ml
- Diagnosed have bacterial vaginosis by an obstetrician and gynecologist
Who cannot join
- Medically unable to perform a pap smear examination
- Experiencing vaginal bleeding of unknown cause
- Diagnosed or suspected of having a malignant disease
- Hypersensitivity to the research treatment to be carried out
- In the last 3 months have received hormone therapy
- Suffering from acute infectious diseases of the genital organs
- Using vaginal therapy in any form
- Suffering from systemic diseases
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Alfa Farma Health Clinic, Obstetrics and Gynecology Doctor's Practice.
Kendari, South East Sulawesi, 93117
Juminten Sp.OG(K), Professor, +6282197276207, inten_azis@yahoo.com
About this study
Official title: Modulation of Vaginal Microbiota by Lactobacillus Sp As a Probiotic and Immunomodulatory Agent in Postmenopausal Women with Bacterial Vaginosis
This study is a double-blind, randomized, controlled trial (RCT) aimed at evaluating the effects of Lactobacillus sp. probiotic administration on the vaginal microbiota changes in postmenopausal women with bacterial vaginosis and how its affect to immunology profile. Postmenopausal women diagnosed with bacterial vaginosis will be recruited as subjects as long as collected period in this study. All patients will receive Metronidazole antibiotic treatment then blind-randomly be divided into two groups: the treatment group, receiving Floragyn® probiotic tablets (Lapi, Indonesia), and the placebo group, receiving Cal 95® (Lapi, Indonesia). As a control, postmenopausal women without bacterial vaginosis will also be included and receive Floragyn® probiotic tablets only.
Read the detailed description
Postmenopausal women experience hormonal changes, particularly in estrogen and progesterone levels. The reduction or even cessation of estrogen secretion in postmenopausal women leads to an increased dominance of pathogenic bacteria in the vagina, which during the premenopausal period was inhibited by Lactobacillus sp. The presence of Lactobacillus in the vaginal epithelium acts as a barrier against external pathogens and produces metabolic byproducts that are unfavorable for the growth of other bacteria. The availability of glycogen, which is influenced by estrogen levels, supports the presence of Lactobacillus as an energy source. This association explains why women entering menopause are at increased risk of developing bacterial vaginosis. In addition, it is known that female reproductive hormones regulate both innate and adaptive immune responses and modulate endocrine functions that influence Th1 and Th2 cytokines, suppress excessive inflammation, and restore homeostasis.
This study conduct to investigate the effects of probiotic therapy on the vaginal microbiota changes in menopausal women and its impact on immunological profiles. Administering Lactobacillus sp. probiotics is expected to modulate bacterial growth disrupted during perimenopause and help restore homeostasis.
All postmenopausal women, during sample collected period, who meet the inclusion criteria will be enrolled as research subjects. Initially, vaginal swabs and venous blood samples will be collected to assess the bacterial vaginosis condition and hematological profiles. Once bacterial vaginosis is diagnosed, subjects will receive standard antibiotic therapy, metronidazole oral 400-500 mg twice daily or 0,75% metronidazole gel 5 grams intravaginally once daily for 5 days. 48 hours after antibiotic administration, participants will be randomly divided into two groups: the treatment group, receiving Floragyn® probiotics, and the placebo group, receiving Cal95®. Probiotic or placebo treatment will be administered orally once daily for two weeks. A healthy control group will also be included for comparison and will receive Floragyn® for two weeks.
Four weeks after the last probiotic dose, vaginal swabs and venous blood samples will be collected. The analysis will include pH, glucose, protein levels, and microbiome composition from the vaginal swabs, while venous blood samples will be analyzed for interleukin 6 and 10 levels, as well as inflammatory markers such as platelets, leukocytes, and differential leukocyte counts. The collected data will be analyzed to evaluate microbiome alterations and inflammatory markers in the treatment and placebo groups.
- Conditions
- Bacterial Vaginosis (BV), Menopause
- Being tested
- Metronidazole + Floragyn® probiotic tablets (Lapi, Indonesia), Metronidazole + Cal95, Floragyn® probiotic tablets (Lapi, Indonesia)
- Keywords
- NO
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metronidazole + Floragyn® probiotic tablets (Lapi, Indonesia)Dietary supplement
Metronidazole, sold under the brand name Flagyl among others, is an antibiotic and antiprotozoal medication. It is used either alone or with other antibiotics to treat pelvic inflammatory disease, endocarditis, and bacterial vaginosis. It is effective for dracunculiasis, giardiasis, trichomoniasis, and amebiasis.
One tablet Floragyn contains Lactobacillus rhamnosus and lactobacillus reuteri, bacteria that are normal flora (good bacteria) of the vagina.
Metronidazole + Cal95Dietary supplement
Metronidazole, sold under the brand name Flagyl among others, is an antibiotic and antiprotozoal medication. It is used either alone or with other antibiotics to treat pelvic inflammatory disease, endocarditis, and bacterial vaginosis. It is effective for dracunculiasis, giardiasis, trichomoniasis, and amebiasis.
Cal 95 is a supplement containing multivitamins and minerals including: Calcium, Zinc, Boron and Magnesium. This tablet is used to help meet calcium needs and maintain bone health in menopausal women.
Floragyn® probiotic tablets (Lapi, Indonesia)Dietary supplement
Given to the control group to ensure the ability of probiotics to maintain a healthy vaginal ecosystem and not the opposite.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This group consist of postmenopausal women diagnosed with bacterial vaginosis. All subjects will receive metronidazole oral 400-500 mg twice daily or 0,75% metronidazole gel 5 grams intravaginally once daily for 5 days, then blind-randomly including to the treatment group and will receive Floragyn® probiotic tablets (Lapi, Indonesia) orally once daily for two weeks. Receives: Dietary Supplement: Metronidazole + Floragyn® probiotic tablets (Lapi, Indonesia) |
| Placebo | Placebo comparator | This group consist of postmenopausal women diagnosed with bacterial vaginosis. All subjects will receive metronidazole oral 400-500 mg twice daily or 0,75% metronidazole gel 5 grams intravaginally once daily for 5 days, then blind-randomly including to the placebo group and will receive Cal95® probiotic tablets (Lapi, Indonesia) orally once daily for two weeks. Receives: Dietary Supplement: Metronidazole + Cal95 |
| Control | Active comparator | This group consist of postmenopausal women with no bacterial vaginosis. All subjects will receive Floragyn® probiotic tablets (Lapi, Indonesia) orally once daily for two weeks. Receives: Dietary Supplement: Floragyn® probiotic tablets (Lapi, Indonesia) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial Vaginosis Status
A health status of woman reproduction diagnosed by nugent score. Nugent score calculations are carried out by looking at bacterial morphology ie Lactobacillus (parallel - sided, gram positive rods), Mobilincus (curved - Gram negative rods), and Gardnerella / Bacteriodes (tiny, gram-variable cocobacilli and rounded, pleomorphic, gram-negative rods with vacuoles). Score 0-3 is normal flora, score 4-6 is intermediate, score 7-10 is bacterial vaginosis.
Measured: At 0, 1, and 7 weeks duration of trial
Secondary outcomes (6)
Total Leukocyte Count
Leukocytes function to detect and fight microorganisms or foreign pathogens that can cause disease, such as viruses, fungi, bacteria, and parasites. Increased levels in the body can be a sign of an ongoing inflammatory process. Leukocyte levels in this study were taken using venous blood samples. its level is expressed in units of 10^3/uL and normal values are 4-10 10^3/uL.
Measured: 0 and 7 weeks duration of trial
Eosinophil Levels
Eosinophils are white blood cells that have a primary function in fighting infections and responding to various types of allergens in the body. Eosinophil levels that exceed the normal range should be watched out for because they can indicate an inflammatory disease. Calculation of eosinophil levels is done using venous blood samples. Eosinophil levels are expressed in % units and normal values are 2-4%.
Measured: 0 and 7 weeks duration of trial
Monocytes level
This type of white blood cell functions to capture and fight attacks by fungi, bacteria, viruses, or parasites that enter the body. The normal level of monocytes is around 2-8% of the total number of white blood cells in the body. The sample used for measurement is venous blood.
Measured: 0 and 7 weeks duration of trial
Lymphocytes level
Lymphocytes are white blood cells that play an important role in protecting the body from various infectious diseases. In addition, the level of lymphocytes in the body can also be a sign of certain medical conditions such as infection and inflammation. The normal level of monocytes is around 20-40% of the total number of white blood cells in the body. The sample used for measurement is venous blood.
Measured: 0 and 7 weeks duration of trial
Interleukin-6 level
Interleukin-6 is a cytokine secreted from body tissues into blood plasma, especially in acute or chronic infection phases, and induces an inflammatory response. The sample used to assess interleukin 6 levels is venous blood with a normal value of interleukin 6 in the blood being <4 pg/ml.
Measured: 0 and 7 weeks duration of trial
Interleukin-10 level
Interleukin-10 is a cytokine abundantly secreted by monocytes, which has pleiotropic effects on the immune system and inflammation by inhibiting the activation and effector functions of T cells, monocytes and macrophages. The sample used to assess interleukin 10 levels is venous blood with a normal value of interleukin 10 in the blood being <18 pg/ml.
Measured: 0 and 7 weeks duration of trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start26 Jun 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Bacterial Vaginosis (BV)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All patients will receive Metronidazole antibiotic treatment then blind-randomly be divided into two groups: the treatment group, receiving Floragyn® probiotic tablets (Lapi, Indonesia), and the placebo group, receiving Cal 95® (Lapi, Indonesia). As a control, postmenopausal women without bacterial vaginosis will also be included and receive Floragyn® probiotic tablets only. Patients are assessed at T0, T1 and T7 week.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasanuddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yenti Purnamasari, Hasanuddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06659380
- Sponsor's protocol ID
- B3/UN4.6.4.5.31-1/ PP36 / 2024
- Status last verified
- Oct 2024
- First submitted
- 23 Oct 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Munoz-Barreno A, Cabezas-Mera F, Tejera E, Machado A. Comparative Effectiveness of Treatments for Bacterial Vaginosis: A Network Meta-Analysis. Antibiotics (Basel). 2021 Aug 13;10(8):978. doi: 10.3390/antibiotics10080978.
PubMed 34439028Cohen CR, Wierzbicki MR, French AL, Morris S, Newmann S, Reno H, Green L, Miller S, Powell J, Parks T, Hemmerling A. Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis. N Engl J Med. 2020 May 14;382(20):1906-1915. doi: 10.1056/NEJMoa1915254.
PubMed 32402161France M, Alizadeh M, Brown S, Ma B, Ravel J. Towards a deeper understanding of the vaginal microbiota. Nat Microbiol. 2022 Mar;7(3):367-378. doi: 10.1038/s41564-022-01083-2. Epub 2022 Mar 4.
PubMed 35246662Laniewski P, Herbst-Kralovetz MM. Connecting microbiome and menopause for healthy ageing. Nat Microbiol. 2022 Mar;7(3):354-358. doi: 10.1038/s41564-022-01071-6.
PubMed 35246661Carlson K, Vadakekut ES. Menopause. 2026 Mar 23. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK507826/
PubMed 29939603Peebles K, Velloza J, Balkus JE, McClelland RS, Barnabas RV. High Global Burden and Costs of Bacterial Vaginosis: A Systematic Review and Meta-Analysis. Sex Transm Dis. 2019 May;46(5):304-311. doi: 10.1097/OLQ.0000000000000972.
PubMed 30624309
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Vaginal Microbiota by Lactobacillus Sp As a Probiotic and Immunomodulatory Agent in Postmenopausal Women with Bacterial Vaginosis
- ClinicalTrials.gov ID
- NCT06659380
- Acronym / sponsor ID
- B3/UN4.6.4.5.31-1/ PP36 / 2024
- Conditions
- Bacterial Vaginosis (BV), Menopause
- Keywords
- NO
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Hasanuddin UniversityUniversity, hospital or other
- Study start
- 26 Jun 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Oct 2024 (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.
This study is a double-blind, randomized, controlled trial (RCT) aimed at evaluating the effects of Lactobacillus sp. probiotic administration on the vaginal microbiota changes in postmenopausal women with bacterial vaginosis and how its affect to immunology profile. Postmenopausal women diagnosed with bacterial vaginosis will be recruited as subjects as long as collected period in this study. All patients will receive Metronidazole antibiotic treatment then blind-randomly be divided into two groups: the treatment group, receiving Floragyn® probiotic tablets (Lapi, Indonesia), and the placebo group, receiving Cal 95® (Lapi, Indonesia). As a control, postmenopausal women without bacterial vaginosis will also be included and receive Floragyn® probiotic tablets only.
Detailed description
Postmenopausal women experience hormonal changes, particularly in estrogen and progesterone levels. The reduction or even cessation of estrogen secretion in postmenopausal women leads to an increased dominance of pathogenic bacteria in the vagina, which during the premenopausal period was inhibited by Lactobacillus sp. The presence of Lactobacillus in the vaginal epithelium acts as a barrier against external pathogens and produces metabolic byproducts that are unfavorable for the growth of other bacteria. The availability of glycogen, which is influenced by estrogen levels, supports the presence of Lactobacillus as an energy source. This association explains why women entering menopause are at increased risk of developing bacterial vaginosis. In addition, it is known that female reproductive hormones regulate both innate and adaptive immune responses and modulate endocrine functions that influence Th1 and Th2 cytokines, suppress excessive inflammation, and restore homeostasis.
This study conduct to investigate the effects of probiotic therapy on the vaginal microbiota changes in menopausal women and its impact on immunological profiles. Administering Lactobacillus sp. probiotics is expected to modulate bacterial growth disrupted during perimenopause and help restore homeostasis.
All postmenopausal women, during sample collected period, who meet the inclusion criteria will be enrolled as research subjects. Initially, vaginal swabs and venous blood samples will be collected to assess the bacterial vaginosis condition and hematological profiles. Once bacterial vaginosis is diagnosed, subjects will receive standard antibiotic therapy, metronidazole oral 400-500 mg twice daily or 0,75% metronidazole gel 5 grams intravaginally once daily for 5 days. 48 hours after antibiotic administration, participants will be randomly divided into two groups: the treatment group, receiving Floragyn® probiotics, and the placebo group, receiving Cal95®. Probiotic or placebo treatment will be administered orally once daily for two weeks. A healthy control group will also be included for comparison and will receive Floragyn® for two weeks.
Four weeks after the last probiotic dose, vaginal swabs and venous blood samples will be collected. The analysis will include pH, glucose, protein levels, and microbiome composition from the vaginal swabs, while venous blood samples will be analyzed for interleukin 6 and 10 levels, as well as inflammatory markers such as platelets, leukocytes, and differential leukocyte counts. The collected data will be analyzed to evaluate microbiome alterations and inflammatory markers in the treatment and placebo groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- All patients will receive Metronidazole antibiotic treatment then blind-randomly be divided into two groups: the treatment group, receiving Floragyn® probiotic tablets (Lapi, Indonesia), and the placebo group, receiving Cal 95® (Lapi, Indonesia). As a control, postmenopausal women without bacterial vaginosis will also be included and receive Floragyn® probiotic tablets only. Patients are assessed at T0, T1 and T7 week.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Metronidazole + Floragyn® probiotic tablets (Lapi, Indonesia)This group consist of postmenopausal women diagnosed with bacterial vaginosis. All subjects will receive metronidazole oral 400-500 mg twice daily or 0,75% metronidazole gel 5 grams intravaginally once daily for 5 days, then blind-randomly including to the treatment group and will receive Floragyn® probiotic tablets (Lapi, Indonesia) orally once daily for two weeks. |
| Placebo | Placebo comparator | Dietary Supplement: Metronidazole + Cal95This group consist of postmenopausal women diagnosed with bacterial vaginosis. All subjects will receive metronidazole oral 400-500 mg twice daily or 0,75% metronidazole gel 5 grams intravaginally once daily for 5 days, then blind-randomly including to the placebo group and will receive Cal95® probiotic tablets (Lapi, Indonesia) orally once daily for two weeks. |
| Control | Active comparator | Dietary Supplement: Floragyn® probiotic tablets (Lapi, Indonesia)This group consist of postmenopausal women with no bacterial vaginosis. All subjects will receive Floragyn® probiotic tablets (Lapi, Indonesia) orally once daily for two weeks. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Postmenopausal with estradiol levels < 25 mg/ml
- Diagnosed have bacterial vaginosis by an obstetrician and gynecologist
Key exclusion criteria (8 listed)
- Medically unable to perform a pap smear examination
- Experiencing vaginal bleeding of unknown cause
- Diagnosed or suspected of having a malignant disease
- Hypersensitivity to the research treatment to be carried out
- In the last 3 months have received hormone therapy
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 |
|---|---|---|
| Metronidazole + Floragyn® probiotic tablets (Lapi, Indonesia)Metronidazole, sold under the brand name Flagyl among others, is an antibiotic and antiprotozoal medication. It is used either alone or with other antibiotics to treat pelvic inflammatory disease, endocarditis, and bacterial vaginosis. It is effective for dracunculiasis, giardiasis, trichomoniasis, and amebiasis. One tablet Floragyn contains Lactobacillus rhamnosus and lactobacillus reuteri, bacteria that are normal flora (good bacteria) of the vagina. | Dietary supplement | Intervention |
| Metronidazole + Cal95Metronidazole, sold under the brand name Flagyl among others, is an antibiotic and antiprotozoal medication. It is used either alone or with other antibiotics to treat pelvic inflammatory disease, endocarditis, and bacterial vaginosis. It is effective for dracunculiasis, giardiasis, trichomoniasis, and amebiasis. Cal 95 is a supplement containing multivitamins and minerals including: Calcium, Zinc, Boron and Magnesium. This tablet is used to help meet calcium needs and maintain bone health in menopausal women. | Dietary supplement | Placebo |
| Floragyn® probiotic tablets (Lapi, Indonesia)Given to the control group to ensure the ability of probiotics to maintain a healthy vaginal ecosystem and not the opposite. | Dietary supplement | Control |
Primary outcome
Bacterial Vaginosis Status
Time frame: At 0, 1, and 7 weeks duration of trial
A health status of woman reproduction diagnosed by nugent score. Nugent score calculations are carried out by looking at bacterial morphology ie Lactobacillus (parallel - sided, gram positive rods), Mobilincus (curved - Gram negative rods), and Gardnerella / Bacteriodes (tiny, gram-variable cocobacilli and rounded, pleomorphic, gram-negative rods with vacuoles). Score 0-3 is normal flora, score 4-6 is intermediate, score 7-10 is bacterial vaginosis.
6 secondary outcomes
Total Leukocyte Count
Time frame: 0 and 7 weeks duration of trial
Eosinophil Levels
Time frame: 0 and 7 weeks duration of trial
Monocytes level
Time frame: 0 and 7 weeks duration of trial
Lymphocytes level
Time frame: 0 and 7 weeks duration of trial
Interleukin-6 level
Time frame: 0 and 7 weeks duration of trial
Interleukin-10 level
Time frame: 0 and 7 weeks duration of trial
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Background: PubMed 34439028Munoz-Barreno A, Cabezas-Mera F, Tejera E, Machado A. Comparative Effectiveness of Treatments for Bacterial Vaginosis: A Network Meta-Analysis. Antibiotics (Basel). 2021 Aug 13;10(8):978. doi: 10.3390/antibiotics10080978.
- Background: PubMed 32402161Cohen CR, Wierzbicki MR, French AL, Morris S, Newmann S, Reno H, Green L, Miller S, Powell J, Parks T, Hemmerling A. Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis. N Engl J Med. 2020 May 14;382(20):1906-1915. doi: 10.1056/NEJMoa1915254.
- Background: PubMed 35246662France M, Alizadeh M, Brown S, Ma B, Ravel J. Towards a deeper understanding of the vaginal microbiota. Nat Microbiol. 2022 Mar;7(3):367-378. doi: 10.1038/s41564-022-01083-2. Epub 2022 Mar 4.
- Background: PubMed 35246661Laniewski P, Herbst-Kralovetz MM. Connecting microbiome and menopause for healthy ageing. Nat Microbiol. 2022 Mar;7(3):354-358. doi: 10.1038/s41564-022-01071-6.
- Background: PubMed 29939603Carlson K, Vadakekut ES. Menopause. 2026 Mar 23. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK507826/
- Background: PubMed 30624309Peebles K, Velloza J, Balkus JE, McClelland RS, Barnabas RV. High Global Burden and Costs of Bacterial Vaginosis: A Systematic Review and Meta-Analysis. Sex Transm Dis. 2019 May;46(5):304-311. doi: 10.1097/OLQ.0000000000000972.
- Moulton Vaishall R (2018). Sex Hormones in Acquired Immunity and Autoimmune Disease. Frontiers in Immunology. Doi: 10.3389/fimmu.2018.02279Link provided by the sponsor.
- Gliniewicz Karol et al (2019). Comparison of the Vaginal Microbiomes of Premenopausal and Postmenopausal Women. Frontiers in Microbiology. Front Microbiol. 2019;10:193. Doi: 10.3389/fmicb.2019.00193Link provided by the sponsor.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metronidazole + Floragyn® probiotic tablets (Lapi, Indonesia), Metronidazole + Cal95 and Floragyn® probiotic tablets (Lapi, Indonesia) in people with Bacterial Vaginosis (BV) and Menopause, run by Hasanuddin University at 1 site in Indonesia.
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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 28 Oct 2024. 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 Indonesia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yenti Purnamasari (+628114058258, yenti.purnamasari@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial Vaginosis Status (time frame: At 0, 1, and 7 weeks duration of trial). 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 NCT06659380, which also lists 6 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 28 Oct 2024.