Peking University Shenzhen Hosptal
Shenzhen, Guangdong, 518036, China
Location status: Recruiting
NCT Number: NCT04771728
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
Interested in participating?
Request Info18 year–55 year
Female
Interventional
Phase 4
Shenzhen, Guangdong, 518036, China
Location status: Recruiting
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Metronidazole vaginal suppositories (200 mg,2 capsules per day,7 days )
Metronidazole vaginal suppositories (200 mg,2 capsules per day,7 days ) and Oral pobiotics(Umeta-mimi,5×109cfu per day,30 days)
Other names: Metronidazole vaginal suppositories adn Probiotics(Umeta-mimi)
Time frame: 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.
Time frame: The first month after treatment
Nugent score
Time frame: 5-7 days after third menstruation after treatment
Nugent score
Time frame: 5-7 days after sixth menstruation after treatment
Nugent score
Contact information is provided by the study sponsor or research team.
Shangrong Fan, M.D.
CONTACT
86-755-83923333 ext. 5505
Yiheng Liang, M.D.
CONTACT
86-755-83923333 ext. 5505
Peking University Shenzhen Hospital
Other
Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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