Probiotics as Adjuvant Treatment for Bacterial Vaginosis

Peking University

Status and phase: Completed; Phase 4

Conditions: Bacterial Vaginosis

Treatments: Drug: "Probiotics" and "Metronidazole"; Drug: Metronidazole Vaginal

Study type: Interventional

Funder types: Other

Identifiers

NCT03894813

PUshenzhenH2018-016

Details and patient eligibility

About

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).

Full 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.

Enrollment: 126 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

Probiotics and Metronidazole

Experimental group

Description:

Probiotics: Oral probiotics(Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) ) (qd, 30 days); Metronidazole: Metronidazole vaginal suppositories (qd,7 days)

Treatment:

Drug: "Probiotics" and "Metronidazole"

Metronidazole vaginal

Active Comparator group

Description:

Metronidazole vaginal suppositories(1 suppositories,qd,7 days )

Treatment:

Drug: Metronidazole Vaginal