Bacterial Vaginosis
Conditions
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 (BV).
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 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.
Interventions
DRUGProbiotics and Metronidazole
Oral probiotics (Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (qd, 30 days)+Metronidazole Suppositories (qd, 7 days)
Metronidazole Suppositories,qd, 7 days
Sponsors
BGI, China
Peking University Shenzhen Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18 to 65 years old, with history of sexual activity, premenopausal women； 2. Nugent Score ≥ 7 for diagnosing BV； 3. Sign informed consent.
Exclusion criteria
1. mixed vaginitis, such as vulvovaginal candidiasis (VVC), Trichomonas vaginalis (TV) infection, Chlamydia trachomatis (CT) infection or gonococcal vaginitis; 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Related Clinical Signs or Symptoms at Baseline | 1 day before starting treatment | 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. |
| Number of Participants With Clinically Effective in Each Study Arm in the 30-day Follow-up | the 30th day after starting treatment | 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. |
| Number of Participants With Clinically Effective in Each Study Arm at the 90-day Follow-up | the 90th day after starting treatment | 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. |
| Number of Participants With Bacteriological Cure in Each Study Arm at the 30-day Follow-up | 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 0-6. Participants who were clinical failures, or had a Nugent score ≥ 7 were therapeutic failures. |
| Number of Participants With Bacteriological Cure in Each Study Arm at the 90-day Follow-up | 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 0-6. Participants who were clinical failures, or had a Nugent score ≥ 7 were therapeutic failures. |
Countries
China
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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) | 52 |
| Metronidazole Vaginal Metronidazole vaginal suppositories(1 suppositories,qd,7 days )
Metronidazole Vaginal: Metronidazole Suppositories,qd, 7 days | 47 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Complain of the research staff and refused to continue the trial | 0 | 1 |
| Overall Study | Lack of Efficacy | 3 | 3 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Pregnancy | 2 | 1 |
| Overall Study | Protocol Violation | 3 | 7 |
| Overall Study | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | Probiotics and Metronidazole | Metronidazole Vaginal | Total |
|---|---|---|---|
| Age, Continuous | 34.2 years STANDARD_DEVIATION 7 | 33.3 years STANDARD_DEVIATION 7.5 | 33.8 years STANDARD_DEVIATION 7.1 |
| Childbirth history At least one previous birth | 31 Participants | 26 Participants | 57 Participants |
| Childbirth history No birth before | 21 Participants | 21 Participants | 42 Participants |
| Current relationship status Married | 36 Participants | 26 Participants | 62 Participants |
| Current relationship status Single, divorced or separated | 16 Participants | 21 Participants | 37 Participants |
| Employment status Stable job | 43 Participants | 41 Participants | 84 Participants |
| Employment status Unemployed or unstable work | 9 Participants | 6 Participants | 15 Participants |
| Race/Ethnicity, Customized Caucasian | 52 Participants | 47 Participants | 99 Participants |
| Sex: Female, Male Female | 52 Participants | 47 Participants | 99 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Sexual activity Had no sexual activity in the last half of the year or vaginal sex less than 3 times per one month | 24 Participants | 27 Participants | 51 Participants |
| Sexual activity Sexual activity (vaginal sex) ≥ 3 times per one month | 28 Participants | 20 Participants | 48 Participants |
| Smoking | 5 Participants | 2 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 63 | 0 / 63 |
| other Total, other adverse events | 5 / 63 | 6 / 63 |
| serious Total, serious adverse events | 0 / 63 | 0 / 63 |
Outcome results
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.
Time frame: the 30th day after starting treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Probiotics and Metronidazole | Number of Participants With Bacteriological Cure in Each Study Arm at the 30-day Follow-up | 30 Participants |
| Metronidazole Vaginal | Number of Participants With Bacteriological Cure in Each Study Arm at the 30-day Follow-up | 28 Participants |
p-value: <0.01Chi-squared
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.
Time frame: the 90th day after starting treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Probiotics and Metronidazole | Number of Participants With Bacteriological Cure in Each Study Arm at the 90-day Follow-up | 19 Participants |
| Metronidazole Vaginal | Number of Participants With Bacteriological Cure in Each Study Arm at the 90-day Follow-up | 23 Participants |
p-value: <0.01Chi-squared
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.
Time frame: the 90th day after starting treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Probiotics and Metronidazole | Number of Participants With Clinically Effective in Each Study Arm at the 90-day Follow-up | 19 Participants |
| Metronidazole Vaginal | Number of Participants With Clinically Effective in Each Study Arm at the 90-day Follow-up | 23 Participants |
p-value: <0.01Chi-squared
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.
Time frame: the 30th day after starting treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Probiotics and Metronidazole | Number of Participants With Clinically Effective in Each Study Arm in the 30-day Follow-up | 30 Participants |
| Metronidazole Vaginal | Number of Participants With Clinically Effective in Each Study Arm in the 30-day Follow-up | 28 Participants |
p-value: <0.01Chi-squared
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.
Time frame: 1 day before starting treatment
Population: Full analysis set of all randomized participants, that is 126, who had baseline samples were tested.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Probiotics and Metronidazole | Number of Participants With Related Clinical Signs or Symptoms at Baseline | 63 Participants |
| Metronidazole Vaginal | Number of Participants With Related Clinical Signs or Symptoms at Baseline | 63 Participants |
p-value: <0.01Chi-squared