Oral Metronidazole With Lactobacillus Vaginal Suppositories to Prevent Recurrence of Bacterial Vaginosis
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|ClinicalTrials.gov Identifier: NCT03099408|
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : June 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Bacterial Vaginosis Recurrence||Drug: Metronidazole Oral Drug: "Metronidazole" and "Lactobacillus"||Phase 4|
Bacterial vaginosis (BV) is the most prevalent cause of symptomatic vaginal discharge in the U.S. and has been associated with complications including preterm delivery of infants, pelvic inflammatory disease (PID), urinary tract infections (UTI) and acquisition/transmission of sexually transmitted diseases (STDs) including human immunodeficiency virus (HIV).
Control of BV has been advocated as a means of decreasing the prevalence of these complications. However, the etiology of BV remains unknown and the current treatment regimens are inadequate in terms of initial cure and recurrence rates.
Based on currently national guidelines by using oral metronidazole 400 BID for 7 days, a high recurrence rate of BV were reported.
We hypothesize that the Oral Metronidazole with Lactobacillus Vaginal Suppositories is better than Oral Metronidazole in Preventing the Recurrence of Bacterial Vaginosis
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Efficacy and Safety of Oral Metronidazole Versus Oral Metronidazole With Lactobacillus Vaginal Suppositories to Prevent the Recurrence of Bacterial Vaginosis|
|Actual Study Start Date :||July 1, 2017|
|Estimated Primary Completion Date :||December 30, 2020|
|Estimated Study Completion Date :||December 30, 2020|
Active Comparator: Metronidazole Oral
Drug: Metronidazole Oral
Oral metronidazole 400 mg BID for 7 days at first month.
Active Comparator: "Metronidazole" and "Lactobacillus"
"Metronidazole" and "Lactobacillus"
Drug: "Metronidazole" and "Lactobacillus"
Oral metronidazole metronidazole 400 mg BID for 7 days at first month and Lactobacillus vaginal suppositories for 10 days at first month,second month and third month.
- Cure rate of BV [ Time Frame: 4 weeks ]Nugent score
- Recurrence of BV [ Time Frame: 12 weeks ]Nugent score
- Recurrence of BV [ Time Frame: 24 weeks ]Nugent score
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03099408
|Contact: Ping Liu, M.D.||86-755-83923333 ext firstname.lastname@example.org|
|Contact: Yiheng Liang, M.D.||86-755-83923333 ext email@example.com|
|Dept Obstetrics and Gynecology||Recruiting|
|Shenzhen, Guangdong, China, 518036|
|Contact: Ping Liu, M.D. 86-755-83923333 ext 5502 firstname.lastname@example.org|
|Contact: Yiheng Liang, M.D. 86-755-83923333 ext 5505 email@example.com|
|Sub-Investigator: Shangrong Fan, M.D.|
|Principal Investigator:||Shangrong Fan, M.D.||Peking University Shenzhen Hospital|
|Principal Investigator:||Salvatore Giovanni Vitale, M.D.||Department of Human Pathology in Adulthood and Childhood, Gaetano Barresi, University of Messina (Italy)|