Probiotics as Adjuvant Treatment for Bacterial Vaginosis
- Conditions
- Bacterial Vaginosis
- Interventions
- Drug: "Probiotics" and "Metronidazole"
- Registration Number
- NCT03894813
- Lead Sponsor
- Peking University Shenzhen Hospital
- Brief Summary
The investigators are trying to determine if oral probiotics (Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (30 days)with metronidazole vaginal suppositories(7 days) is better than using metronidazole vaginal suppositories only in preventing the recurrence of bacterial vaginosis (BV).
- Detailed Description
Studies have shown that oral probiotics 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-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (30 days) with metronidazole vaginal suppositories(7 days) in the treatment of bacterial vaginosis 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, the first month after treatment, the third month after treatment and the sixth month after treatment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 126
- Aged 18 to 65 years old, with history of sexual activity, premenopausal women；
- Nugent Score ≥ 7 for diagnosing BV；
- Sign informed consent.
- mixed vaginitis, such as vulvovaginal candidiasis (VVC), Trichomonas vaginalis (TV) infection, Chlamydia trachomatis (CT) infection or gonococcal vaginitis;
- History of systemic organic diseases or psychiatric diseases;
- Planning for or during pregnancy, lactation, menstruation;
- within 5 days of onset of the disease, any antibiotics has been used;
- Long-term use of contraceptives or immunosuppressant;
- Anaphylactic constitution or allergic to known ingredients of research drugs.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Probiotics and Metronidazole "Probiotics" and "Metronidazole" Probiotics: Oral probiotics(Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) ) (qd, 30 days); Metronidazole: Metronidazole vaginal suppositories (qd,7 days) Metronidazole vaginal Metronidazole Vaginal Metronidazole vaginal suppositories(1 suppositories,qd,7 days )
- Primary Outcome Measures
Name Time Method Number of Participants With Related Clinical Signs or Symptoms at Baseline 1 day before starting treatment Clinical signs and symptoms of bacteria vaginosis (BV), including homogeneous and thin vaginal discharge, unpleasant odour (such as a "fishy" smell) and vulvar discomfort (such as itching or burning), were recorded at baseline, the number of participants with related clinical signs or symptoms at Baseline were calculated.
Number of Participants With Clinically Effective in Each Study Arm in the 30-day Follow-up the 30th day after starting treatment Clinical signs and symptoms of BV, including homogeneous and thin vaginal discharge, unpleasant odour (such as a "fishy" smell) and vulvar discomfort (such as itching or burning), were recorded at the 30-day, the number of participants with clinically effective (with the sign or symptoms disappeared or released compared with the baseline data) were calculated.
Number of Participants With Clinically Effective in Each Study Arm at the 90-day Follow-up the 90th day after starting treatment Clinical signs and symptoms of BV, including homogeneous and thin vaginal discharge, unpleasant odour (such as a "fishy" smell) and vulvar discomfort (such as itching or burning), were recorded at the 30-day, the number of participants with clinically effective (with the sign or symptoms disappeared or released compared with the 30-day follow-up data) were calculated.
Number of Participants With Bacteriological Cure in Each Study Arm at the 30-day Follow-up the 30th day after starting treatment A vaginal swab for bacteriological assessment of BV by Nugent criteria was performed. The Nugent score can range from 0 to 10. Bacteriological cure of BV was defined as a normal Nugent score of 0-6. Participants who were clinical failures, or had a Nugent score ≥ 7 were therapeutic failures.
Number of Participants With Bacteriological Cure in Each Study Arm at the 90-day Follow-up the 90th day after starting treatment A vaginal swab for bacteriological assessment of BV by Nugent criteria was performed. The Nugent score can range from 0 to 10. Bacteriological cure of BV was defined as a normal Nugent score of 0-6. Participants who were clinical failures, or had a Nugent score ≥ 7 were therapeutic failures.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Peking University Shenzhen Hospital
🇨🇳Shenzhen, Guangdong, China