A Prospective, Randomized Controlled Study of the Probiotics as Adjuvant Treatment for Bacterial Vaginosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2026-12-01

Brief Summary

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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

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Detailed Description

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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

Conditions

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Bacterial Vaginosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Metronidazole vaginal

Metronidazole vaginal suppositories (200 mg,2 capsules per day,7 days )

Group Type ACTIVE_COMPARATOR

Metronidazole vaginal suppositories

Intervention Type DRUG

Metronidazole vaginal suppositories (200 mg,2 capsules per day,7 days )

Metronidazole vagianl and Probiotics(Umeta-mimi)

Metronidazole:Metronidazole vaginal suppositories (200 mg,2 capsules per day,7 days ) Probiotics:Oral Umeta-mimi( 5×109cfu per day,30 days）

Group Type EXPERIMENTAL

Metronidazole vaginal suppositories and Probiotics(Umeta-mimi)

Intervention Type DRUG

Metronidazole vaginal suppositories (200 mg,2 capsules per day,7 days ) and Oral pobiotics(Umeta-mimi,5×109cfu per day,30 days）

Interventions

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Metronidazole vaginal suppositories

Metronidazole vaginal suppositories (200 mg,2 capsules per day,7 days )

Intervention Type 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）

Intervention Type DRUG

Other Intervention Names

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Metronidazole vaginal suppositories adn Probiotics(Umeta-mimi）

Eligibility Criteria

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Inclusion Criteria

1. Aged 18 to 55 years old, with history of sexual activity,
2. Amsel criterion for diagnosing BV
3. Sign informed consent

Exclusion Criteria

1. History of systemic organic diseases or psychiatric diseases
2. Planning for or during pregnancy, lactation, menstruation
3. within 5 days of onset of the disease, any antibiotics has been used
4. Long-term use of contraceptives or immunosuppressant
5. Anaphylactic constitution or allergic to known ingredients of research drugs
6. No same fixed partner (RSP) before and after treatment

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes