Trial Outcomes & Findings for Use of Boric Acid in Combination With Probiotics for the Treatment of Vaginal Infections (NCT NCT02860845)
NCT ID: NCT02860845
Last Updated: 2019-11-19
Results Overview
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)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
48 participants
Primary outcome timeframe
Baseline and at 2 weeks after treatment finalization
Results posted on
2019-11-19
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
|
Overall Study
Analyzed Patients
|
22
|
23
|
|
Overall Study
COMPLETED
|
22
|
23
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of Boric Acid in Combination With Probiotics for the Treatment of Vaginal Infections
Baseline characteristics by cohort
| Measure |
Boric Acid and Probiotics
n=24 Participants
Boric acid with L.gasseri and L.rhamnosus
Boric acid and probiotics: Vaginal capsules administered once a day during 7 days.
|
Antibiotic/Antifungal
n=24 Participants
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.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
36.36 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
37.7 years
STANDARD_DEVIATION 6.1 • n=7 Participants
|
36.83 years
STANDARD_DEVIATION 7.22 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, non latino
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
24 participants
n=5 Participants
|
24 participants
n=7 Participants
|
48 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and at 2 weeks after treatment finalizationPopulation: Subscore Sobel Score values at baseline and visit 1 (from 0 to 3)
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)
Outcome measures
| Measure |
Boric Acid and Probiotics Baseline
n=24 Participants
Boric acid with L.gasseri and L.rhamnosus
Boric acid and probiotics: Vaginal capsules administered once a day during 7 days.
|
Antibiotic/Antifungal Baseline
n=24 Participants
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.
|
Boric Acid and Probiotics Visit 1
n=22 Participants
Boric acid with L.gasseri and L.rhamnosus
Boric acid and probiotics: Vaginal capsules administered once a day during 7 days.
|
Antibiotic/Antifungal Visit 1
n=23 Participants
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.
|
|---|---|---|---|---|
|
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
|
1.21 score on a scale
Standard Deviation 1.06
|
0.18 score on a scale
Standard Deviation 0.50
|
0.22 score on a scale
Standard Deviation 0.67
|
|
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
|
1.58 score on a scale
Standard Deviation 1.02
|
0.41 score on a scale
Standard Deviation 0.80
|
0.57 score on a scale
Standard Deviation 0.95
|
|
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
|
0.96 score on a scale
Standard Deviation 1.12
|
0.14 score on a scale
Standard Deviation 0.64
|
0.17 score on a scale
Standard Deviation 0.65
|
|
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
|
0.42 score on a scale
Standard Deviation 0.72
|
0.05 score on a scale
Standard Deviation 0.21
|
0 score on a scale
Standard Deviation 0.00
|
|
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
|
1.96 score on a scale
Standard Deviation 1.08
|
0.23 score on a scale
Standard Deviation 0.53
|
0.35 score on a scale
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: Baseline and 2 weeks after treatment finalizationLactobacillus spp count. in vaginal discharge at baseline and at visit 1, determined by vaginal cultures.
Outcome measures
| Measure |
Boric Acid and Probiotics Baseline
n=24 Participants
Boric acid with L.gasseri and L.rhamnosus
Boric acid and probiotics: Vaginal capsules administered once a day during 7 days.
|
Antibiotic/Antifungal Baseline
n=24 Participants
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.
|
Boric Acid and Probiotics Visit 1
n=22 Participants
Boric acid with L.gasseri and L.rhamnosus
Boric acid and probiotics: Vaginal capsules administered once a day during 7 days.
|
Antibiotic/Antifungal Visit 1
n=23 Participants
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.
|
|---|---|---|---|---|
|
Change in the Level of Lactobacillus in Vaginal Flora Determined by Vaginal Cultures.
|
51.59 Count of Organism/counting chamber
Standard Deviation 50.74
|
49.30 Count of Organism/counting chamber
Standard Deviation 59.77
|
81.82 Count of Organism/counting chamber
Standard Deviation 84.34
|
66.09 Count of Organism/counting chamber
Standard Deviation 77.27
|
SECONDARY outcome
Timeframe: At 3 months after recruitmentDescriptive of the proportion of patients with vulvovaginitis recurrence
Outcome measures
| Measure |
Boric Acid and Probiotics Baseline
n=22 Participants
Boric acid with L.gasseri and L.rhamnosus
Boric acid and probiotics: Vaginal capsules administered once a day during 7 days.
|
Antibiotic/Antifungal Baseline
n=23 Participants
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.
|
Boric Acid and Probiotics Visit 1
Boric acid with L.gasseri and L.rhamnosus
Boric acid and probiotics: Vaginal capsules administered once a day during 7 days.
|
Antibiotic/Antifungal Visit 1
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.
|
|---|---|---|---|---|
|
Number of Participants With Recurrent Infections
No recurrence
|
17 Participants
|
14 Participants
|
—
|
—
|
|
Number of Participants With Recurrent Infections
Recurrence
|
5 Participants
|
9 Participants
|
—
|
—
|
Adverse Events
Boric Acid and Probiotics
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Antibiotic/Antifungal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place