Probiotic Efficacy in Postmenopausal Women with Bacterial Vaginosis

NCT06659380 | Recruiting DMC

• 1 other identifier: B3/UN4.6.4.5.31-1/ PP36 / 2024
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Bacterial Vaginosis (BV); Menopause

Keywords

NO

Outcome Measures

Primary Outcomes (1)

• 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.

  At 0, 1, and 7 weeks duration of trial

Secondary Outcomes (6)

• Total Leukocyte Count

  0 and 7 weeks duration of trial

• Eosinophil Levels

  0 and 7 weeks duration of trial

• Monocytes level

  0 and 7 weeks duration of trial

• Lymphocytes level

  0 and 7 weeks duration of trial

• Interleukin-6 level

  0 and 7 weeks duration of trial

Study Arms (3)

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.

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.

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.

Dietary Supplement: Floragyn® probiotic tablets (Lapi, Indonesia)

Interventions

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.

Intervention

Metronidazole + Cal95 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. 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.

Placebo

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.

Control

Eligibility Criteria

• Gender Eligibility Details: Menopausal women with cessation of menopausal cycles for at least 12 months
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal with estradiol levels \< 25 mg/ml
• Diagnosed have bacterial vaginosis by an obstetrician and gynecologist

You may not qualify if:

• 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

Sponsors & Collaborators

• Hasanuddin University: lead

Study Sites (1)

Alfa Farma Health Clinic, Obstetrics and Gynecology Doctor's Practice.

Kendari, South East Sulawesi, 93117, Indonesia

RECRUITING

Related Publications (6)

• 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.

  PMID: 34439028 BACKGROUND

• Cohen 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.

  PMID: 32402161 BACKGROUND

• France 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.

  PMID: 35246662 BACKGROUND

• Laniewski 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.

  PMID: 35246661 BACKGROUND

• Peacock K, Carlson K, Ketvertis KM. Menopause. 2023 Dec 21. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK507826/

  PMID: 29939603 BACKGROUND

• Peebles 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.

  PMID: 30624309 BACKGROUND

Related Links

• Moulton Vaishall R (2018). Sex Hormones in Acquired Immunity and Autoimmune Disease. Frontiers in Immunology. Doi: 10.3389/fimmu.2018.02279
• 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.2019.00193

MeSH Terms

Conditions

Vaginosis, Bacterial

Interventions

Metronidazole

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Yenti Purnamasari

CONTACT

+628114058258; yenti.purnamasari@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participant, care provider, investigator, and outcomes assessor are blind to treatment status as well as patients and families.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 26, 2024
• Study Start: June 26, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 28, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)