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Probiotics as Adjuvant Treatment for Bacterial Vaginosis

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ClinicalTrials.gov Identifier: NCT03894813
Recruitment Status : Recruiting
First Posted : March 29, 2019
Last Update Posted : March 29, 2019
Sponsor:
Collaborator:
BGI, China
Information provided by (Responsible Party):
Shangrong Fan, Peking University Shenzhen Hospital

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Bacterial Vaginosis Drug: "Probiotics" and "Metronidazole" Drug: Metronidazole Vaginal Phase 4

Detailed Description:
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 (BV) 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases

Arm Intervention/treatment
Experimental: 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)
Drug: "Probiotics" and "Metronidazole"
Oral probiotics (Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (qd, 30 days)+Metronidazole Suppositories (qd, 7 days)
Other Name: Umeta-Miyue, Lactobacillus rhamnosus GR-1 & Lactobacillus reuteri RC-14 and Metronidazole Suppositories

Active Comparator: Metronidazole vaginal
Metronidazole vaginal suppositories(1 suppositories,qd,7 days )
Drug: Metronidazole Vaginal
Metronidazole Suppositories,qd, 7 days
Other Name: Metronidazole Suppositories




Primary Outcome Measures :
  1. Baseline data of BV [ Time Frame: 1 day before starting treatment ]
    Amsel criterion for diagnosing BV, stated that the presence of 3 of the following four criteria shows diagnosis of BV: Increased homogeneous thin vaginal discharge; pH of the secretion greater than 4.5; Amine odor when potassium hydroxide 10% solution is added to a drop of vaginal secretions. The baseline data including: clinical symptoms such as itching or burning; "fishy" smell; homogeneous thin vaginal discharge; laboratory examination such as Nugent score; pH; clue cell etc.

  2. Number of participants with clinically effective in each study arm [ Time Frame: the 30th day after starting treatment ]
    Clinically effective was defined by clinical symptoms & signs disappeared or alleviated and less than one laboratory examination is abnormal, including: no itching; normal physiological vaginal discharge; whiff test negative for any amine "fishy" odor; saline wet mount less than 20% for clue cells; and vaginal pH is <=4.5. A clinical failure was defined by persistent itching or homogeneous thin vaginal discharge and at least one laboratory examination is abnormal.

  3. Number of participants with clinically effective in each study arm [ Time Frame: the 90th day after starting treatment ]
    Clinically effective was defined by clinical symptoms & signs disappeared or alleviated and less than one laboratory examination is abnormal, including: no itching; normal physiological vaginal discharge; whiff test negative for any amine "fishy" odor; saline wet mount less than 20% for clue cells; and vaginal pH is <=4.5. A clinical failure was defined by persistent itching or homogeneous thin vaginal discharge and at least one laboratory examination is abnormal.

  4. Number of participants with clinically effective in each study arm [ Time Frame: the 180th day after starting treatment ]
    Clinically effective was defined by clinical symptoms & signs disappeared or alleviated and less than one laboratory examination is abnormal, including: no itching; normal physiological vaginal discharge; whiff test negative for any amine "fishy" odor; saline wet mount less than 20% for clue cells; and vaginal pH is <=4.5. A clinical failure was defined by persistent itching or homogeneous thin vaginal discharge and at least one laboratory examination is abnormal.

  5. Number of participants with bacteriological cure in each study arm [ Time Frame: the 30th day after starting treatment ]
    A vaginal swab for bacteriological assessment of BV by Nugent criteria was performed. The Nugent score can range from 0 to 10. Bacteriological cure of BV was defined as a normal Nugent score of 0-3. Participants who were clinical failures, or had a Nugent score >3 were therapeutic failures.

  6. Number of participants with bacteriological cure in each study arm [ Time Frame: the 90th day after starting treatment ]
    A vaginal swab for bacteriological assessment of BV by Nugent criteria was performed. The Nugent score can range from 0 to 10. Bacteriological cure of BV was defined as a normal Nugent score of 0-3. Participants who were clinical failures, or had a Nugent score >3 were therapeutic failures.

  7. Number of participants with bacteriological cure in each study arm [ Time Frame: the 180th day after starting treatment ]
    A vaginal swab for bacteriological assessment of BV by Nugent criteria was performed. The Nugent score can range from 0 to 10. Bacteriological cure of BV was defined as a normal Nugent score of 0-3. Participants who were clinical failures, or had a Nugent score >3 were therapeutic failures.


Secondary Outcome Measures :
  1. Basic vaginal megagenomic and its reconstruction in clinical treatment in each study arm [ Time Frame: 1 day before starting treatment ]
    α-diversity and β-diversity can be used to indicate the reconstruction process of vaginal microecology. α-diversity is the mean species diversity in sites or habitats at a local scale, it can be calculated as a weighted generalized mean of the within-subunit species proportional abundances, and then take the inverse of this mean. β-diversity is the ratio between regional and local species diversity, it can be calculated as β = γ/α.

  2. Basic vaginal megagenomic and its reconstruction in clinical treatment in each [ Time Frame: the 30th day after starting treatment ]
    α-diversity and β-diversity can be used to indicate the reconstruction process of vaginal microecology. α-diversity is the mean species diversity in sites or habitats at a local scale, it can be calculated as a weighted generalized mean of the within-subunit species proportional abundances, and then take the inverse of this mean. β-diversity is the ratio between regional and local species diversity, it can be calculated as β = γ/α.

  3. Basic vaginal megagenomic and its reconstruction in clinical treatment in each [ Time Frame: the 90th day after starting treatment ]
    α-diversity and β-diversity can be used to indicate the reconstruction process of vaginal microecology. α-diversity is the mean species diversity in sites or habitats at a local scale, it can be calculated as a weighted generalized mean of the within-subunit species proportional abundances, and then take the inverse of this mean. β-diversity is the ratio between regional and local species diversity, it can be calculated as β = γ/α.

  4. Basic vaginal megagenomic and its reconstruction in clinical treatment in each [ Time Frame: the 180th day after starting treatment ]
    α-diversity and β-diversity can be used to indicate the reconstruction process of vaginal microecology. α-diversity is the mean species diversity in sites or habitats at a local scale, it can be calculated as a weighted generalized mean of the within-subunit species proportional abundances, and then take the inverse of this mean. β-diversity is the ratio between regional and local species diversity, it can be calculated as β = γ/α.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged 18 to 65 years old, with history of sexual activity, and clinically diagnosed as simple BV.
  2. Amsel criterion for diagnosing BV, stated that the presence of 3 of the following four criteria shows diagnosis of BV:

    • Increased homogeneous thin vaginal discharge;
    • pH of the secretion greater than 4.5;
    • Amine odor when potassium hydroxide 10% solution is added to a drop of vaginal secretions;
    • Presence of clue cells in wet preparations
  3. Sign informed consent

Exclusion Criteria:

  1. Mixed vaginitis such as combining with simple VVC, simple TC or gonococcal vaginitis etc.
  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

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): NCT03894813


Contacts
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Contact: Shangrong Fan, M.D. 86-755-83923333 ext 5502 fanshangrong@163.com
Contact: Yiheng Liang, M.D. 86-755-83923333 ext 5505 13510331823@163.com

Locations
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China, Guangdong
Peking University Shenzhen Hospital Recruiting
Shenzhen, Guangdong, China, 518036
Contact: Yiheng Liang, M.D.    96-0755-83923333 ext 5518    13510331823@163.com   
Contact: Ping Liu, M.D.    86-755-83923333 ext 5505    253783006@qq.com   
Principal Investigator: Shangrong Fan, M.D.         
Sponsors and Collaborators
Peking University Shenzhen Hospital
BGI, China
Investigators
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Study Director: Ruifang Wu, M.D. Dept of Obstetrics and Gynecology,Peking University Shenzhen Hospital

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Responsible Party: Shangrong Fan, Departmemt of Obstetrics and Gynecology, Peking University Shenzhen Hospital
ClinicalTrials.gov Identifier: NCT03894813     History of Changes
Other Study ID Numbers: PUshenzhenH2008-016
First Posted: March 29, 2019    Key Record Dates
Last Update Posted: March 29, 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

Additional relevant MeSH terms:
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Vaginal Diseases
Vaginosis, Bacterial
Genital Diseases, Female
Bacterial Infections
Vaginitis
Metronidazole
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents