Health TrialsbyHealthPanel

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

ConditionBacterial Vaginosis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorPeking University Shenzhen Hospital

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Aged 18 to 55 years old, with history of sexual activity,

Amsel criterion for diagnosing BV

Sign informed consent

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Metronidazole vaginal suppositories

    Drug

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

  • Metronidazole vaginal suppositories and Probiotics(Umeta-mimi)

    Drug

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

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Metronidazole vaginalActive comparator 1 intervention
Group B: Metronidazole vagianl and Probiotics(Umeta-mimi)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Cure rate of BV

Assessments with different Units of Measure:clinical symptoms such as itching or burning; "fishy" smell; homogeneous thin vaginal discharge;Nugent score; pH\>4.5; clue cell.

Time frame
14 days after treatment

Secondary outcomes

1

Recurrence of BV

Nugent score

Time frame
The first month after treatment
2

Recurrence of BV

Nugent score

Time frame
5-7 days after third menstruation after treatment
3

Recurrence of BV

Nugent score

Time frame
5-7 days after sixth menstruation after treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University Shenzhen Hospital

Lead sponsor

BGI, China

Collaborator

Source ClinicalTrials.gov
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