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

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ClinicalTrials.gov Identifier: NCT03099408
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
Shangrong Fan, Peking University Shenzhen Hospital

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

Condition or disease Intervention/treatment Phase
Bacterial Vaginosis Recurrence Drug: Metronidazole Oral Drug: "Metronidazole" and "Lactobacillus" Phase 4

Detailed Description:

Bacterial vaginosis (BV) is the most prevalent cause of symptomatic vaginal discharge in the U.S. and has been associated with complications including preterm delivery of infants, pelvic inflammatory disease (PID), urinary tract infections (UTI) and acquisition/transmission of sexually transmitted diseases (STDs) including human immunodeficiency virus (HIV).

Control of BV has been advocated as a means of decreasing the prevalence of these complications. However, the etiology of BV remains unknown and the current treatment regimens are inadequate in terms of initial cure and recurrence rates.

Based on currently national guidelines by using oral metronidazole 400 BID for 7 days, a high recurrence rate of BV were reported.

We hypothesize that the Oral Metronidazole with Lactobacillus Vaginal Suppositories is better than Oral Metronidazole in Preventing the Recurrence of Bacterial Vaginosis


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Efficacy and Safety of Oral Metronidazole Versus Oral Metronidazole With Lactobacillus Vaginal Suppositories to Prevent the Recurrence of Bacterial Vaginosis
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases

Arm Intervention/treatment
Active Comparator: Metronidazole Oral
Metronidazole Oral
Drug: Metronidazole Oral
Oral metronidazole 400 mg BID for 7 days at first month.

Active Comparator: "Metronidazole" and "Lactobacillus"
"Metronidazole" and "Lactobacillus"
Drug: "Metronidazole" and "Lactobacillus"
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.




Primary Outcome Measures :
  1. Cure rate of BV [ Time Frame: 4 weeks ]
    Nugent score


Secondary Outcome Measures :
  1. Recurrence of BV [ Time Frame: 12 weeks ]
    Nugent score

  2. Recurrence of BV [ Time Frame: 24 weeks ]
    Nugent score



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Ages Eligible for Study:   18 Years to 48 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03099408


Contacts
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Contact: Ping Liu, M.D. 86-755-83923333 ext 5505 253783006@qq.com
Contact: Yiheng Liang, M.D. 86-755-83923333 ext 5502 13510331823@163.com

Locations
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China, Guangdong
Dept Obstetrics and Gynecology Recruiting
Shenzhen, Guangdong, China, 518036
Contact: Ping Liu, M.D.    86-755-83923333 ext 5502    253783006@qq.com   
Contact: Yiheng Liang, M.D.    86-755-83923333 ext 5505    13510331823@163.com   
Sub-Investigator: Shangrong Fan, M.D.         
Sponsors and Collaborators
Peking University Shenzhen Hospital
Investigators
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Principal Investigator: Shangrong Fan, M.D. Peking University Shenzhen Hospital
Principal Investigator: Salvatore Giovanni Vitale, M.D. Department of Human Pathology in Adulthood and Childhood, Gaetano Barresi, University of Messina (Italy)

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Responsible Party: Shangrong Fan, Profesor, Peking University Shenzhen Hospital
ClinicalTrials.gov Identifier: NCT03099408     History of Changes
Other Study ID Numbers: 2016PUSZH001
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shangrong Fan, Peking University Shenzhen Hospital:
Recurrence
Lactobacillus Vaginal Suppositories
Additional relevant MeSH terms:
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Vaginosis, Bacterial
Vaginal Diseases
Recurrence
Disease Attributes
Pathologic Processes
Genital Diseases, Female
Bacterial Infections
Vaginitis
Metronidazole
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents