Probiotic Efficacy in Postmenopausal Women with Bacterial Vaginosis

Официальное название

Modulation of Vaginal Microbiota by Lactobacillus Sp As a Probiotic and Immunomodulatory Agent in Postmenopausal Women with Bacterial Vaginosis

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка 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.
• Пищевая добавка Metronidazole + Cal95
  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 m
• Пищевая добавка 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.

Первичные конечные точки

• Bacterial Vaginosis Status [Срок оценки: At 0, 1, and 7 weeks duration of trial]

Вторичные конечные точки (6)

• Total Leukocyte Count [Срок оценки: 0 and 7 weeks duration of trial]
• Eosinophil Levels [Срок оценки: 0 and 7 weeks duration of trial]
• Monocytes level [Срок оценки: 0 and 7 weeks duration of trial]
• Lymphocytes level [Срок оценки: 0 and 7 weeks duration of trial]
• Interleukin-6 level [Срок оценки: 0 and 7 weeks duration of trial]
• Interleukin-10 level [Срок оценки: 0 and 7 weeks duration of trial]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Индонезия · 1 центр

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

Публикации

• 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
• 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
• 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
• 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
• Carlson 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/ PMID 29939603
• 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

Идентификаторы

NCT: NCT06659380 · B3/UN4.6.4.5.31-1/ PP36 / 2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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