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| Name | Class |
|---|---|
| BGI, China | OTHER |
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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 (BV).
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 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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotics and Metronidazole | Experimental | Probiotics: Oral probiotics(Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) ) (qd, 30 days); Metronidazole: Metronidazole vaginal suppositories (qd,7 days) |
|
| Metronidazole vaginal | Active Comparator | Metronidazole vaginal suppositories(1 suppositories,qd,7 days ) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "Probiotics" and "Metronidazole" | Drug | Oral probiotics (Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (qd, 30 days)+Metronidazole Suppositories (qd, 7 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Related Clinical Signs or Symptoms at Baseline | Clinical signs and symptoms of bacteria vaginosis (BV), including homogeneous and thin vaginal discharge, unpleasant odour (such as a "fishy" smell) and vulvar discomfort (such as itching or burning), were recorded at baseline, the number of participants with related clinical signs or symptoms at Baseline were calculated. | 1 day before starting treatment |
| Number of Participants With Clinically Effective in Each Study Arm in the 30-day Follow-up | Clinical signs and symptoms of BV, including homogeneous and thin vaginal discharge, unpleasant odour (such as a "fishy" smell) and vulvar discomfort (such as itching or burning), were recorded at the 30-day, the number of participants with clinically effective (with the sign or symptoms disappeared or released compared with the baseline data) were calculated. | the 30th day after starting treatment |
| Number of Participants With Clinically Effective in Each Study Arm at the 90-day Follow-up | Clinical signs and symptoms of BV, including homogeneous and thin vaginal discharge, unpleasant odour (such as a "fishy" smell) and vulvar discomfort (such as itching or burning), were recorded at the 30-day, the number of participants with clinically effective (with the sign or symptoms disappeared or released compared with the 30-day follow-up data) were calculated. | the 90th day after starting treatment |
| Number of Participants With Bacteriological Cure in Each Study Arm at the 30-day Follow-up | 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 0-6. Participants who were clinical failures, or had a Nugent score ≥ 7 were therapeutic failures. | the 30th day after starting treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ruifang Wu, M.D. | Dept of Obstetrics and Gynecology,Peking University Shenzhen Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Shenzhen Hospital | Shenzhen | Guangdong | 518036 | China |
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Women who came to the gynaecological clinic of Peking University Shenzhen Hospital, China, between March 2019 and June 2019 with abnormal vaginal discharge symptoms were recruited.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) "Probiotics" and "Metronidazole": Oral probiotics (Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (qd, 30 days)+Metronidazole Suppositories (qd, 7 days) |
| FG001 | Metronidazole Vaginal | Metronidazole vaginal suppositories(1 suppositories,qd,7 days ) Metronidazole Vaginal: Metronidazole Suppositories,qd, 7 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) "Probiotics" and "Metronidazole": Oral probiotics (Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (qd, 30 days)+Metronidazole Suppositories (qd, 7 days) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Related Clinical Signs or Symptoms at Baseline | Clinical signs and symptoms of bacteria vaginosis (BV), including homogeneous and thin vaginal discharge, unpleasant odour (such as a "fishy" smell) and vulvar discomfort (such as itching or burning), were recorded at baseline, the number of participants with related clinical signs or symptoms at Baseline were calculated. | Full analysis set of all randomized participants, that is 126, who had baseline samples were tested. | Posted | Count of Participants | Participants | 1 day before starting treatment |
|
6 months
All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none were observed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) "Probiotics" and "Metronidazole": Oral probiotics (Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (qd, 30 days)+Metronidazole Suppositories (qd, 7 days) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| vaginal itching or burning | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Shangrong Fan | Peking University Shenzhen Hospital | 86-0755-83923333 | fanshangrong@163.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 20, 2021 | May 24, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 20, 2021 | Jun 17, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D016585 | Vaginosis, Bacterial |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014627 | Vaginitis |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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|
| Metronidazole Vaginal | Drug | Metronidazole Suppositories,qd, 7 days |
|
|
| Number of Participants With Bacteriological Cure in Each Study Arm at the 90-day Follow-up |
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 0-6. Participants who were clinical failures, or had a Nugent score ≥ 7 were therapeutic failures. |
| the 90th day after starting treatment |
| Lost to Follow-up |
|
| Pregnancy |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Complain of the research staff and refused to continue the trial |
|
| BG001 | Metronidazole Vaginal | Metronidazole vaginal suppositories(1 suppositories,qd,7 days ) Metronidazole Vaginal: Metronidazole Suppositories,qd, 7 days |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Employment status | Count of Participants | Participants |
|
| Smoking | Count of Participants | Participants |
|
| Current relationship status | Count of Participants | Participants |
|
| Childbirth history | Count of Participants | Participants |
|
| Sexual activity | Count of Participants | Participants |
|
| OG001 | Metronidazole Vaginal | Metronidazole vaginal suppositories(1 suppositories,qd,7 days ) Metronidazole Vaginal: Metronidazole Suppositories,qd, 7 days |
|
|
|
| Primary | Number of Participants With Clinically Effective in Each Study Arm in the 30-day Follow-up | Clinical signs and symptoms of BV, including homogeneous and thin vaginal discharge, unpleasant odour (such as a "fishy" smell) and vulvar discomfort (such as itching or burning), were recorded at the 30-day, the number of participants with clinically effective (with the sign or symptoms disappeared or released compared with the baseline data) were calculated. | Posted | Count of Participants | Participants | the 30th day after starting treatment |
|
|
|
|
| Primary | Number of Participants With Clinically Effective in Each Study Arm at the 90-day Follow-up | Clinical signs and symptoms of BV, including homogeneous and thin vaginal discharge, unpleasant odour (such as a "fishy" smell) and vulvar discomfort (such as itching or burning), were recorded at the 30-day, the number of participants with clinically effective (with the sign or symptoms disappeared or released compared with the 30-day follow-up data) were calculated. | Posted | Count of Participants | Participants | the 90th day after starting treatment |
|
|
|
|
| Primary | Number of Participants With Bacteriological Cure in Each Study Arm at the 30-day Follow-up | 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 0-6. Participants who were clinical failures, or had a Nugent score ≥ 7 were therapeutic failures. | Posted | Count of Participants | Participants | the 30th day after starting treatment |
|
|
|
|
| Primary | Number of Participants With Bacteriological Cure in Each Study Arm at the 90-day Follow-up | 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 0-6. Participants who were clinical failures, or had a Nugent score ≥ 7 were therapeutic failures. | Posted | Count of Participants | Participants | the 90th day after starting treatment |
|
|
|
|
| 0 |
| 63 |
| 0 |
| 63 |
| 5 |
| 63 |
| EG001 | Metronidazole Vaginal | Metronidazole vaginal suppositories(1 suppositories,qd,7 days ) Metronidazole Vaginal: Metronidazole Suppositories,qd, 7 days | 0 | 63 | 0 | 63 | 6 | 63 |
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| D014623 |
| Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D019602 |
| Food and Beverages |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |