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

Phase 4

Recruiting

• Conditions: Bacterial Vaginosis
• Interventions: Drug: Metronidazole vaginal suppositories; Drug: Metronidazole vaginal suppositories and Probiotics(Umeta-mimi)

• Registration Number: NCT04771728
• Lead Sponsor: Peking University Shenzhen Hospital

Brief Summary

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

Study Timeline

• Study Start: 2020-02-01
• Study First Submitted: 2020-09-28
• Study First Submitted QC: 2021-02-24
• Study First Posted: 2021-02-25
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-08
• Last Update Posted: 2024-06-11
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metronidazole vaginal	Metronidazole vaginal suppositories	Metronidazole vaginal suppositories (200 mg,2 capsules per day,7 days )
Metronidazole vagianl and Probiotics(Umeta-mimi)	Metronidazole vaginal suppositories 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）

Primary Outcome Measures

Name	Time	Method
Cure rate of BV	14 days after treatment	Assessments with different Units of Measure:clinical symptoms such as itching or burning; "fishy" smell; homogeneous thin vaginal discharge;Nugent score; pH\>4.5; clue cell.

Secondary Outcome Measures

Name	Time	Method
Recurrence of BV	5-7 days after sixth menstruation after treatment	Nugent score

Trial Locations

Locations (1)

Peking University Shenzhen Hosptal; 🇨🇳 Shenzhen, Guangdong, China