RecruitingPhase 4NCT04771728

A Prospective, Randomized Controlled Study of the Probiotics as Adjuvant Treatment for Bacterial Vaginosis

Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital


Sponsor

Peking University Shenzhen Hospital

Enrollment

140 participants

Start Date

Feb 1, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

The investigators are trying to determine if oral Probiotics(Umeta-mimi,30 days) with Metronidazole vaginal suppositories (7 days) is better than using Metronidazole vaginal suppositories(7 days) only in preventing the recurrence of bacterial vaginosis


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 55 Years

Inclusion Criteria3

  • Aged 18 to 55 years old, with history of sexual activity,
  • Amsel criterion for diagnosing BV
  • Sign informed consent

Exclusion Criteria6

  • 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
  • No same fixed partner (RSP) before and after treatment

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Interventions

DRUGMetronidazole vaginal suppositories

Metronidazole vaginal suppositories (200 mg,2 capsules per day,7 days )

DRUGMetronidazole vaginal suppositories and Probiotics(Umeta-mimi)

Metronidazole vaginal suppositories (200 mg,2 capsules per day,7 days ) and Oral pobiotics(Umeta-mimi,5×109cfu per day,30 days)


Locations(1)

Peking University Shenzhen Hosptal

Shenzhen, Guangdong, China

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NCT04771728


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