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

Bacterial Vaginosis Clinical Trial

Official title:

Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04771728
• Other study ID #: PUshenzhenH2020-0310
• Status: Recruiting
• Phase: Phase 4
• Start date: February 1, 2020
• Est. completion date: December 1, 2024

Study information

• Verified date: June 2024
• Source: Peking University Shenzhen Hospital
• Contact: Shangrong Fan, M.D.
• Phone: 86-755-83923333
• Email: fanshangrong[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

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

Locations

Country	Name	City	State
China	Peking University Shenzhen Hosptal	Shenzhen	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Peking University Shenzhen Hospital	BGI, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cure rate of BV	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.	14 days after treatment
Secondary	Recurrence of BV	Nugent score	The first month after treatment
Secondary	Recurrence of BV	Nugent score	5-7 days after third menstruation after treatment
Secondary	Recurrence of BV	Nugent score	5-7 days after sixth menstruation after treatment