Probiotics as Adjuvant Treatment for Bacterial Vaginosis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-26

Study Completion Date

2020-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Efficacy of a Vaginally Administered Probiotic Lactobacilli Delivery System.

NCT00752193

Bacterial Vaginosis

COMPLETED NA

Analysis of Ameliorative Effects of Oral Probiotics on Bacterial Vaginosis

NCT03116789

Bacterial Vaginosis

COMPLETED NA

Role of Oral Lactobacilli on Vaginal Flora of Pregnant Women

NCT04638257

Bacterial Vaginosis

COMPLETED PHASE1

Effects of Oral Probiotic Product on Vaginal Microbial Community and Parameters of Vaginal Health

NCT03543982

Vaginal Health

COMPLETED NA

Probiotic on Prevention of GBS Vaginal Infection During Pregnancy

NCT03688321

Infection, Bacterial

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bacterial Vaginosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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)

Group Type EXPERIMENTAL

"Probiotics" and "Metronidazole"

Intervention Type DRUG

Oral probiotics (Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (qd, 30 days)+Metronidazole Suppositories (qd, 7 days)

Metronidazole vaginal

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

Group Type ACTIVE_COMPARATOR

Metronidazole Vaginal

Intervention Type DRUG

Metronidazole Suppositories,qd, 7 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

"Probiotics" and "Metronidazole"

Oral probiotics (Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (qd, 30 days)+Metronidazole Suppositories (qd, 7 days)

Intervention Type DRUG

Metronidazole Vaginal

Metronidazole Suppositories,qd, 7 days

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Umeta-Miyue, Lactobacillus rhamnosus GR-1 & Lactobacillus reuteri RC-14 and Metronidazole Suppositories Metronidazole Suppositories

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No