Oral Metronidazole With Lactobacillus Vaginal Suppositories to Prevent Recurrence of Bacterial Vaginosis

NCT03099408 | Completed Phase 4

• 1 other identifier: 2016PUSZH001
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

We are trying to determine if Oral Metronidazole with Lactobacillus Vaginal Suppositories is better than Oral Metronidazole in Preventing the Recurrence of Bacterial Vaginosis

Conditions

Bacterial Vaginosis; Recurrence

Keywords

Recurrence; Lactobacillus Vaginal Suppositories

Outcome Measures

Primary Outcomes (1)

• Cure rate of BV

  Nugent score

  4 weeks

Secondary Outcomes (2)

• Recurrence of BV

  12 weeks

• Recurrence of BV

  24 weeks

Study Arms (2)

Metronidazole Oral

ACTIVE COMPARATOR

Metronidazole Oral

Drug: Metronidazole Oral

"Metronidazole" and "Lactobacillus"

ACTIVE COMPARATOR

"Metronidazole" and "Lactobacillus"

Drug: "Metronidazole" and "Lactobacillus"

Interventions

Metronidazole Oral DRUG

Oral metronidazole 400 mg BID for 7 days at first month.

Metronidazole Oral

"Metronidazole" and "Lactobacillus" DRUG

Oral metronidazole metronidazole 400 mg BID for 7 days at first month and Lactobacillus vaginal suppositories for 10 days at first month,second month and third month.

"Metronidazole" and "Lactobacillus"

Eligibility Criteria

• Age: 18 Years - 48 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women be at least 18 years of age
• Have symptoms of vaginal odor and or/discharge
• Meet the clinical (Amsel) criteria for BV
• Willing to participate in research

You may not qualify if:

• Presence of another vaginal infection or STD
• Allergy to metronidazole
• Pregnant or nursing
• Use of oral or intravaginal antibiotics within the past 2 weeks
• HIV or other chronic disease
• Inability to keep return appointments
• Contraindications for Lactobacillus Vaginal Suppositories（those without sexual history）

Sponsors & Collaborators

• Peking University Shenzhen Hospital: lead

Study Sites (1)

Dept Obstetrics and Gynecology

Shenzhen, Guangdong, 518036, China

Location

MeSH Terms

Conditions

Vaginosis, Bacterial; Recurrence

Interventions

Metronidazole; Lacteol

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Shangrong Fan, M.D.

  Peking University Shenzhen Hospital

  PRINCIPAL INVESTIGATOR

• Salvatore Giovanni Vitale, M.D.

  Department of Human Pathology in Adulthood and Childhood, University of Messina (Italy)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profesor

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: April 4, 2017
• Study Start: July 1, 2017
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: February 1, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)