Clinical trial NCT03894813: Probiotics as Adjuvant Treatment for Bacterial Vaginosis
Official title: Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bacterial Vaginosis
Lead sponsor: Peking University Shenzhen Hospital
Sponsor class: OTHER
Collaborators: name: BGI, China
First posted: 2019-03-29
Enrollment: 126
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Aged 18 to 65 years old, with history of sexual activity, premenopausal women；
2. Nugent Score ≥ 7 for diagnosing BV；
3. Sign informed consent.

Exclusion Criteria:

1. mixed vaginitis, such as vulvovaginal candidiasis (VVC), Trichomonas vaginalis (TV) infection, Chlamydia trachomatis (CT) infection or gonococcal vaginitis;
2. History of systemic organic diseases or psychiatric diseases;
3. Planning for or during pregnancy, lactation, menstruation;
4. within 5 days of onset of the disease, any antibiotics has been used;
5. Long-term use of contraceptives or immunosuppressant;
6. Anaphylactic constitution or allergic to known ingredients of research drugs.

Primary outcomes:
measure: Number of Participants With Related Clinical Signs or Symptoms at Baseline
timeFrame: 1 day before starting treatment
measure: Number of Participants With Clinically Effective in Each Study Arm in the 30-day Follow-up
timeFrame: the 30th day after starting treatment
measure: Number of Participants With Clinically Effective in Each Study Arm at the 90-day Follow-up
timeFrame: the 90th day after starting treatment
measure: Number of Participants With Bacteriological Cure in Each Study Arm at the 30-day Follow-up
timeFrame: the 30th day after starting treatment
measure: Number of Participants With Bacteriological Cure in Each Study Arm at the 90-day Follow-up
timeFrame: the 90th day after starting treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
state: Guangdong
Study officials:
affiliation: Dept of Obstetrics and Gynecology,Peking University Shenzhen Hospital
name: Ruifang Wu, M.D.
role: STUDY_DIRECTOR
References: