A Prospective, Randomized Controlled Study of the Probiotics as Adjuvant Treatment for Bacterial Vaginosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Metronidazole vaginal suppositories, Metronidazole vaginal suppositories and Probiotics(Umeta-mimi).
- Who it may be relevant to
- Registry conditions: Bacterial Vaginosis. Basic parameters: 18 years — 55 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital
Overview
The investigators are trying to determine if oral Probiotics(Umeta-mimi,30 days) with Metronidazole vaginal suppositories (7 days) is better than using Metronidazole vaginal suppositories(7 days) only in preventing the recurrence of bacterial vaginosis
Detailed description
Studies have shown that oral Probiotics(Umeta-mimi) can significantly promote the recovery of vaginal flora mainly because intestinal microbiota can migrate and affect vaginal microecology. This project aims to evaluate the efficacy of oral Probiotics(Umeta-mimi,30 days) with Metronidazole vaginal suppositories(7 days) in the treatment of bacterial vaginosis (BV) and to explore the correlation between vaginal flora and fecal flora by detecting the metagenomics of vaginal secretions and intestinal feces at the time of baseline phase,14 days after treatment， the first month after treatment, 5-7 days after third menstruation after treatment and 5-7 days after sixth menstruation after treatment
Interventions
- Drug Metronidazole vaginal suppositories
Metronidazole vaginal suppositories (200 mg,2 capsules per day,7 days ) - Drug Metronidazole vaginal suppositories and Probiotics(Umeta-mimi)
Metronidazole vaginal suppositories (200 mg,2 capsules per day,7 days ) and Oral pobiotics(Umeta-mimi,5×109cfu per day,30 days）
Primary outcome measures
- Cure rate of BV [Time frame: 14 days after treatment]
Secondary outcome measures (3)
- Recurrence of BV [Time frame: The first month after treatment]
- Recurrence of BV [Time frame: 5-7 days after third menstruation after treatment]
- Recurrence of BV [Time frame: 5-7 days after sixth menstruation after treatment]
Eligibility criteria
Inclusion criteria
- Aged 18 to 55 years old, with history of sexual activity,
- Amsel criterion for diagnosing BV
- Sign informed consent
Exclusion criteria
- History of systemic organic diseases or psychiatric diseases
- Planning for or during pregnancy, lactation, menstruation
- within 5 days of onset of the disease, any antibiotics has been used
- Long-term use of contraceptives or immunosuppressant
- Anaphylactic constitution or allergic to known ingredients of research drugs
- No same fixed partner (RSP) before and after treatment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University Shenzhen Hosptal — Shenzhen
Publications
- Qi F, Fan S, Fang C, Ge L, Lyu J, Huang Z, Zhao S, Zou Y, Huang L, Liu X, Liang Y, Zhang Y, Zhong Y, Zhang H, Xiao L, Zhang X. Orally administrated Lactobacillus gasseri TM13 and Lactobacillus crispatus LG55 can restore the vaginal health of patients recovering from bacterial vaginosis. Front Immunol. 2023 Jul 27;14:1125239. doi: 10.3389/fimmu.2023.1125239. eCollection 2023. PMID 37575226
Identifiers
NCT: NCT04771728 · PUshenzhenH2020-0310