Journal of lower genital tract disease · 2020
Oral Intake of Lactobacilli Can Be Helpful in Symptomatic Bacterial Vaginosis: A Randomized Clinical Study.
Клиническое исследование II фазыСтатьяРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Reznichenko Halyna, Henyk Nataliya, Maliuk Viktor, Khyzhnyak Tetyana, Tynna Yevhenia, Filipiuk Ihor, Veresniuk Nataliia, Zubrytska Larysa, Quintens Johan, Richir Karl, Gerasymov Sergiy
Аннотация
OBJECTIVE: The aim of the study was to explore a role of oral intake of a mixture of 3 Lactobacillus species in recurrence of bacterial vaginosis (BV).
MATERIALS AND METHODS: A phase 2 randomized parallel group prospective placebo-controlled study conducted at 7 clinical centers enrolled 18- to 45-years-old women with recent symptomatic BV cured with metronidazole. Within 48 hours after completion of metronidazole therapy, eligible women received 1 capsule of the verum (5.4 billion Lactobacillus crispatus LMG S-29995, Lactobacillus brevis, and Lactobacillus acidophilus in proportion of 60%, 20%, and 20%, respectively), or the placebo supplement 2 times daily for the first 7 days and 1 time daily for the next 8 to 120 days. The primary outcome measure was the percentage of recurrence of BV, which was defined as 3 of 4 Amsel criteria plus abnormal vaginal discharge/vulvar odor during 4 months of intake of the test dietary supplement. Differences between the groups were assessed with Z test for proportions.
RESULTS: One hundred sixty-six women were analyzed in the verum (82 patients) and the placebo group (82 patients). Recurrence of BV was documented in 15 (18.3%) of 82 women in the verum group and 27 (32.1%) of 84 in the placebo group (p = .014). Rates of survival without BV rates were higher in the verum group (Cox F test, p = .018). Both verum and placebo supplements were well tolerated.
CONCLUSIONS: Oral intake of L. crispatus LMG S-29995, L. brevis, and L. acidophilus can significantly decrease percent of recurrences of BV in recently treated women and prolong time to recurrence of the disease.
MATERIALS AND METHODS: A phase 2 randomized parallel group prospective placebo-controlled study conducted at 7 clinical centers enrolled 18- to 45-years-old women with recent symptomatic BV cured with metronidazole. Within 48 hours after completion of metronidazole therapy, eligible women received 1 capsule of the verum (5.4 billion Lactobacillus crispatus LMG S-29995, Lactobacillus brevis, and Lactobacillus acidophilus in proportion of 60%, 20%, and 20%, respectively), or the placebo supplement 2 times daily for the first 7 days and 1 time daily for the next 8 to 120 days. The primary outcome measure was the percentage of recurrence of BV, which was defined as 3 of 4 Amsel criteria plus abnormal vaginal discharge/vulvar odor during 4 months of intake of the test dietary supplement. Differences between the groups were assessed with Z test for proportions.
RESULTS: One hundred sixty-six women were analyzed in the verum (82 patients) and the placebo group (82 patients). Recurrence of BV was documented in 15 (18.3%) of 82 women in the verum group and 27 (32.1%) of 84 in the placebo group (p = .014). Rates of survival without BV rates were higher in the verum group (Cox F test, p = .018). Both verum and placebo supplements were well tolerated.
CONCLUSIONS: Oral intake of L. crispatus LMG S-29995, L. brevis, and L. acidophilus can significantly decrease percent of recurrences of BV in recently treated women and prolong time to recurrence of the disease.