CandidiasisPhase 4DOBONCT02860845
Use of Boric Acid in Combination With Probiotics for the Treatment of Vaginal Infections
A Phase 4 study testing Boric acid and probiotics, Antibiotic (Clindamycin) and Antifungal (Clotrimazole) in people with Candidiasis and Vaginosis, Bacterial, run by Laboratorios Ordesa at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Candidiasis, Vaginosis, Bacterial
- What is being tested?
- Boric acid and probiotics, Antibiotic (Clindamycin) and Antifungal (Clotrimazole)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSpain
- Study dates
- 12 Jul 2016to 30 Nov 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Pilot Study to Compare the Efficacy of a Combination of Vaginal Capsules With Acid Boric, L.Gasseri and L.Rhamnosus Versus the Reference Medication in Patients With Vaginal Candidiasis or Bacterial Vaginosis
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).
Read the 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.
- Conditions
- Candidiasis, Vaginosis, Bacterial
- Being tested
- Boric acid and probiotics, Antibiotic (Clindamycin), Antifungal (Clotrimazole)
- Medical subject headings
- Candidiasis, Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boric acid and probioticsDevice
Vaginal capsules administered once a day during 7 days.
Antibiotic (Clindamycin)Drug
Also called Clindamycin
Vaginal capsules containing a reference antibiotic (when bacterial vaginosis is suspected) administered once a day during 3 days.
Antifungal (Clotrimazole)Drug
Also called Clotrimazole
Vaginal capsules containing a reference anti-fungal (when candidiasis is suspected) administered once a day during 6 days.
| Study group | Role | What they receive |
|---|---|---|
| Boric acid and probiotics | Experimental | Boric acid with L.gasseri and L.rhamnosus Receives: Device: Boric acid and probiotics |
| Antibiotic/Antifungal | Active comparator | Antibiotic: Clindamicine Antifungal: Clotrimazol Receives: Drug: Antibiotic (Clindamycin); Drug: Antifungal (Clotrimazole) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline and at 2 weeks after treatment finalization
Secondary outcomes (2)
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.
Measured: Baseline and 2 weeks after treatment finalization
Number of Participants With Recurrent Infections
Descriptive of the proportion of patients with vulvovaginitis recurrence
Measured: At 3 months after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study start12 Jul 2016
- Primary completion16 Oct 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CandidiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Ordesa
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clever Instruments S.L.
- Responsible party
- Sponsor
- Investigators
- Juan A Tena, Dr., Principal investigator, Ginemed Sevilla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02860845
- Sponsor's protocol ID
- DOBO-01-16
- Acronym
- DOBO
- Status last verified
- Nov 2019
- First submitted
- 19 Jul 2016
- Last updated
- 19 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Pilot Study to Compare the Efficacy of a Combination of Vaginal Capsules With Acid Boric, L.Gasseri and L.Rhamnosus Versus the Reference Medication in Patients With Vaginal Candidiasis or Bacterial Vaginosis
- ClinicalTrials.gov ID
- NCT02860845
- Acronym / sponsor ID
- DOBO / DOBO-01-16
- Conditions
- Candidiasis, Vaginosis, Bacterial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Laboratorios OrdesaIndustry (pharma, biotech, devices)
- Collaborators
- Clever Instruments S.L.
- Study start
- 12 Jul 2016 (actual)
- Primary completion
- 16 Oct 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 9 Aug 2016 (estimated)
- Results
- Posted 4 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Boric acid and probiotics | Experimental | Device: Boric acid and probioticsBoric acid with L.gasseri and L.rhamnosus |
| Antibiotic/Antifungal | Active comparator | Drug: Antibiotic (Clindamycin), Drug: Antifungal (Clotrimazole)Antibiotic: Clindamicine Antifungal: Clotrimazol |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Boric acid and probioticsVaginal capsules administered once a day during 7 days. | Device | Boric acid and probiotics |
| Antibiotic (Clindamycin)Also: ClindamycinVaginal capsules containing a reference antibiotic (when bacterial vaginosis is suspected) administered once a day during 3 days. | Drug | Antibiotic/Antifungal |
| Antifungal (Clotrimazole)Also: ClotrimazoleVaginal capsules containing a reference anti-fungal (when candidiasis is suspected) administered once a day during 6 days. | Drug | Antibiotic/Antifungal |
Primary outcome
Change in the Presence of Vaginitis Clinical Symptoms Determined by Sobel Score.
Time frame: 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)
2 secondary outcomes
Change in the Level of Lactobacillus in Vaginal Flora Determined by Vaginal Cultures.
Time frame: Baseline and 2 weeks after treatment finalization
Number of Participants With Recurrent Infections
Time frame: At 3 months after recruitment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan A Tena, Dr. principal investigator
Ginemed Sevilla
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Boric acid and probiotics, Antibiotic (Clindamycin) and Antifungal (Clotrimazole) in people with Candidiasis and Vaginosis, Bacterial, run by Laboratorios Ordesa at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Presence of Vaginitis Clinical Symptoms Determined by Sobel Score. (time frame: Baseline and at 2 weeks after treatment finalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2019.