Candidiasis, Vaginosis, Bacterial
Conditions
Brief summary
The purpose of this study is to determine whether a formula of boric acid and probiotics for vaginal application is effective in the treatment of symptomatic episodes of vulvovaginitis in comparison to pharmacological reference controls (depending on the suspected diagnosis).
Detailed description
Multicentre, Open, Prospective, Randomized, Controlled. Women with suspected vaginal infection will be randomized and distributed into two groups (control or boric acid + probiotics). Follow-up will last for three months and consists in 3 visits and a telephone interview.
Interventions
DEVICEBoric acid and probiotics
Vaginal capsules administered once a day during 7 days.
DRUGAntibiotic (Clindamycin)
Vaginal capsules containing a reference antibiotic (when bacterial vaginosis is suspected) administered once a day during 3 days.
DRUGAntifungal (Clotrimazole)
Vaginal capsules containing a reference anti-fungal (when candidiasis is suspected) administered once a day during 6 days.
Sponsors
Clever Instruments S.L.
Laboratorios Ordesa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age over 18 years and agreement to participate by signing the consent form. * Women with clinical manifestations of acute infectious vulvovaginitis (burning, pruritus, erythema, oedema, and abnormal vaginal discharge).
Exclusion criteria
* Clinical findings compatible with Chlamydia trachomatis, Neisseria gonorrhoeae or Trichomonas vaginalis infection. * Use of anti-fungal, antibiotic or probiotic medication within last 2 weeks prior to the study. * Patients receiving other treatment (drug, probiotics or vitamin supplements) that can significantly interfere with study evaluations during the 3 months of follow-up. * Pregnant or high risk for pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Presence of Vaginitis Clinical Symptoms Determined by Sobel Score. | Baseline and at 2 weeks after treatment finalization | Semi-quantitative scale where itching, erythema, edema, stinging and abnormal vaginal discharge are scored from 0 to 3: absent (0), mild (1), moderate (2), severe (3). Worse result is 3 (severe) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Level of Lactobacillus in Vaginal Flora Determined by Vaginal Cultures. | Baseline and 2 weeks after treatment finalization | Lactobacillus spp count. in vaginal discharge at baseline and at visit 1, determined by vaginal cultures. |
| Number of Participants With Recurrent Infections | At 3 months after recruitment | Descriptive of the proportion of patients with vulvovaginitis recurrence |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Boric Acid and Probiotics Boric acid with L.gasseri and L.rhamnosus
Boric acid and probiotics: Vaginal capsules administered once a day during 7 days. | 24 |
| Antibiotic/Antifungal Antibiotic: Clindamicine Antifungal: Clotrimazol
Antibiotic (Clindamycin): Vaginal capsules containing a reference antibiotic (when bacterial vaginosis is suspected) administered once a day during 3 days.
Antifungal (Clotrimazole): Vaginal capsules containing a reference anti-fungal (when candidiasis is suspected) administered once a day during 6 days. | 24 |
| Total | 48 |
Baseline characteristics
| Characteristic | Boric Acid and Probiotics | Antibiotic/Antifungal | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 24 Participants | 48 Participants |
| Age, Continuous | 36.36 years STANDARD_DEVIATION 8.2 | 37.7 years STANDARD_DEVIATION 6.1 | 36.83 years STANDARD_DEVIATION 7.22 |
| Race/Ethnicity, Customized Latino | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White, non latino | 23 Participants | 24 Participants | 47 Participants |
| Region of Enrollment Spain | 24 participants | 24 participants | 48 participants |
| Sex: Female, Male Female | 24 Participants | 24 Participants | 48 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 24 |
| other Total, other adverse events | 0 / 24 | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 |
Outcome results
Primary
Change in the Presence of Vaginitis Clinical Symptoms Determined by Sobel Score.
Semi-quantitative scale where itching, erythema, edema, stinging and abnormal vaginal discharge are scored from 0 to 3: absent (0), mild (1), moderate (2), severe (3). Worse result is 3 (severe)
Time frame: Baseline and at 2 weeks after treatment finalization
Population: Subscore Sobel Score values at baseline and visit 1 (from 0 to 3)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Boric Acid and Probiotics Baseline | Change in the Presence of Vaginitis Clinical Symptoms Determined by Sobel Score. | Edema Sobel Score | 0.5 score on a scale | Standard Deviation 0.78 |
| Boric Acid and Probiotics Baseline | Change in the Presence of Vaginitis Clinical Symptoms Determined by Sobel Score. | Itching Sobel Score | 1.63 score on a scale | Standard Deviation 0.85 |
| Boric Acid and Probiotics Baseline | Change in the Presence of Vaginitis Clinical Symptoms Determined by Sobel Score. | abnormal vaginal discharge | 1.67 score on a scale | Standard Deviation 0.96 |
| Boric Acid and Probiotics Baseline | Change in the Presence of Vaginitis Clinical Symptoms Determined by Sobel Score. | Erythema Sobel Score | 0.92 score on a scale | Standard Deviation 0.93 |
| Boric Acid and Probiotics Baseline | Change in the Presence of Vaginitis Clinical Symptoms Determined by Sobel Score. | Stinging sobel score | 1.13 score on a scale | Standard Deviation 0.85 |
| Antibiotic/Antifungal Baseline | Change in the Presence of Vaginitis Clinical Symptoms Determined by Sobel Score. | Erythema Sobel Score | 0.96 score on a scale | Standard Deviation 1.12 |
| Antibiotic/Antifungal Baseline | Change in the Presence of Vaginitis Clinical Symptoms Determined by Sobel Score. | Edema Sobel Score | 0.42 score on a scale | Standard Deviation 0.72 |
| Antibiotic/Antifungal Baseline | Change in the Presence of Vaginitis Clinical Symptoms Determined by Sobel Score. | abnormal vaginal discharge | 1.96 score on a scale | Standard Deviation 1.08 |
| Antibiotic/Antifungal Baseline | Change in the Presence of Vaginitis Clinical Symptoms Determined by Sobel Score. | Itching Sobel Score | 1.58 score on a scale | Standard Deviation 1.02 |
| Antibiotic/Antifungal Baseline | Change in the Presence of Vaginitis Clinical Symptoms Determined by Sobel Score. | Stinging sobel score | 1.21 score on a scale | Standard Deviation 1.06 |
| Boric Acid and Probiotics Visit 1 | Change in the Presence of Vaginitis Clinical Symptoms Determined by Sobel Score. | Erythema Sobel Score | 0.14 score on a scale | Standard Deviation 0.64 |
| Boric Acid and Probiotics Visit 1 | Change in the Presence of Vaginitis Clinical Symptoms Determined by Sobel Score. | Stinging sobel score | 0.18 score on a scale | Standard Deviation 0.5 |
| Boric Acid and Probiotics Visit 1 | Change in the Presence of Vaginitis Clinical Symptoms Determined by Sobel Score. | Itching Sobel Score | 0.41 score on a scale | Standard Deviation 0.8 |
| Boric Acid and Probiotics Visit 1 | Change in the Presence of Vaginitis Clinical Symptoms Determined by Sobel Score. | Edema Sobel Score | 0.05 score on a scale | Standard Deviation 0.21 |
| Boric Acid and Probiotics Visit 1 | Change in the Presence of Vaginitis Clinical Symptoms Determined by Sobel Score. | abnormal vaginal discharge | 0.23 score on a scale | Standard Deviation 0.53 |
| Antibiotic/Antifungal Visit 1 | Change in the Presence of Vaginitis Clinical Symptoms Determined by Sobel Score. | Edema Sobel Score | 0 score on a scale | Standard Deviation 0 |
| Antibiotic/Antifungal Visit 1 | Change in the Presence of Vaginitis Clinical Symptoms Determined by Sobel Score. | Itching Sobel Score | 0.57 score on a scale | Standard Deviation 0.95 |
| Antibiotic/Antifungal Visit 1 | Change in the Presence of Vaginitis Clinical Symptoms Determined by Sobel Score. | Stinging sobel score | 0.22 score on a scale | Standard Deviation 0.67 |
| Antibiotic/Antifungal Visit 1 | Change in the Presence of Vaginitis Clinical Symptoms Determined by Sobel Score. | Erythema Sobel Score | 0.17 score on a scale | Standard Deviation 0.65 |
| Antibiotic/Antifungal Visit 1 | Change in the Presence of Vaginitis Clinical Symptoms Determined by Sobel Score. | abnormal vaginal discharge | 0.35 score on a scale | Standard Deviation 0.83 |
Secondary
Change in the Level of Lactobacillus in Vaginal Flora Determined by Vaginal Cultures.
Lactobacillus spp count. in vaginal discharge at baseline and at visit 1, determined by vaginal cultures.
Time frame: Baseline and 2 weeks after treatment finalization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Boric Acid and Probiotics Baseline | Change in the Level of Lactobacillus in Vaginal Flora Determined by Vaginal Cultures. | 51.59 Count of Organism/counting chamber | Standard Deviation 50.74 |
| Antibiotic/Antifungal Baseline | Change in the Level of Lactobacillus in Vaginal Flora Determined by Vaginal Cultures. | 49.30 Count of Organism/counting chamber | Standard Deviation 59.77 |
| Boric Acid and Probiotics Visit 1 | Change in the Level of Lactobacillus in Vaginal Flora Determined by Vaginal Cultures. | 81.82 Count of Organism/counting chamber | Standard Deviation 84.34 |
| Antibiotic/Antifungal Visit 1 | Change in the Level of Lactobacillus in Vaginal Flora Determined by Vaginal Cultures. | 66.09 Count of Organism/counting chamber | Standard Deviation 77.27 |
Secondary
Number of Participants With Recurrent Infections
Descriptive of the proportion of patients with vulvovaginitis recurrence
Time frame: At 3 months after recruitment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boric Acid and Probiotics Baseline | Number of Participants With Recurrent Infections | No recurrence | 17 Participants |
| Boric Acid and Probiotics Baseline | Number of Participants With Recurrent Infections | Recurrence | 5 Participants |
| Antibiotic/Antifungal Baseline | Number of Participants With Recurrent Infections | Recurrence | 9 Participants |
| Antibiotic/Antifungal Baseline | Number of Participants With Recurrent Infections | No recurrence | 14 Participants |