Oral CandidiasesPhase 4NCT05916729
Use of Maqui Berry Extract in Treating Oral Candidiasis in Diabetes Mellitus Patients and Systemically Healthy Persons
A Phase 4 study testing Miconazole and CandBerrol® lozenges in people with Oral Candidiases, run by University of Belgrade at 1 site in Serbia.
Trial summary
Fungi from the genus Candida present the saprophytic flora of the cavity. This saprophytic yeast can cause different form of oral infections at immunocompromised patients as well as at subjects with impaired local oral microbiota e.g. wearers of dentures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Candidiases
- What is being tested?
- Miconazole and CandBerrol® lozenges
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSerbia
- Study dates
- 1 May 2021to 1 Jan 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18
- Candida spp. infection (Clinical signs, symptoms and microbiological confirmation of infection)
- Systematically healthy wearing acrylate denture (Group A)
- Diabetic patients with/without acrylate denture (Groups B and C)
Who cannot join
- Presence of other systemic diseases
- Presence other oral mucosal contions
Trial locations and contacts
1 site in 1 country.
Serbia1 site, 1 recruiting
- Recruiting
Natasa Nikolic Jakoba
Belgrade
Natasa Nikolic Jakoba, +381638269909, natasa.nikolic.jakoba@stomf.bg.ac.rs
About this study
Official title: "The Effect of Using Preparations With Maqui Berry Extract in Treating Oral Candidiasis in Patients With Diabetes Mellitus and Systemically Healthy Persons"
Fungi from the genus Candida present the saprophytic flora of the cavity. This saprophytic yeast can cause different form of oral infections at immunocompromised patients as well as at subjects with impaired local oral microbiota e.g. wearers of dentures.
The most common cause of oral candidiasis is Candida albicans, but recently, non-albicans species has also been commonly isolated. One of the reasons for growing frequency of non-albicans species is traditional antifungal therapy. Standard antifungal therapy, which means elimination of yeasts, lead to antimicrobial resistance, dysbiosis and higher incidence of non-albicans species In order to overcome these limitations, the new antimicrobial therapy is based on anti-virulence strategy. This approach relays on disarming the microorganism, instead of killing or stopping their growth, which is especially important for saprophytes.
In case of Candida albicans the main goal is preventing transition from cell to hyphal form.
Read the detailed description
The aim of this study is to assess the efficiency of a dietary supplement based on Maqui Berry extract (CandBerrol® lozenge, Phytonet, Serbia) in treatment of oral candidiasis in patients who are treated with standard antifungal therapy - miconazole, 2%, (Daktanol® oral gel, Galenika, Serbia).
The study would be conducted at Clinic for Periodontology and Oral Medicine, School of Dental Medicine, University of Belgrade. The subjects would be recruited from the pool of patients who come for the treatment of suspected oral candidiasis.
A total of 90 patients with confirmed fungal infection (Candida spp.) of the oral cavity would be included in the study and divided into three groups (30 subjects per group), matched by gender and age:
Group A: systemically healthy subjects wearing acrylate dentures
Group B: subjects with diabetes mellitus without acrylate dentures
Group C: subjects with diabetes mellitus wearing acrylate dentures
Each group is further subdivided into two treatment subgroups:
- Active control, treated with miconazole, 2% (Daktanol® oral gel, Galenika, Serbia).
- Experimental, treated with miconazole, 2% with Maqui Berry extract (CandBerrol® lozenge, Phytonet, Serbia)
During the first examination, patients signed their consent to participate in the research based on written and oral information about the type, duration and expected outcome of the research. Following signing the consent, the research sheet specifically designed for this study would be fulfilled.
Both therapy protocol (active control and experimental therapy) would be administrated for 14 days. Therapy protocols would also include advices for oral and denture hygiene and diet. Clinical and microbiological controls would be conducted after 7th, 18th and 30th days from the start of therapy.
Patients who would not be able to follow the study instructions, would be excluded from the study.
Statistical analysis would be analyzed using the SPSS software program using appropriate statistical tests.
- Conditions
- Oral Candidiases
- Being tested
- Miconazole, CandBerrol® lozenges
- Medical subject headings
- Candidiasis, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiconazoleDrug
Also called Daktanol®
Protocol for active control groups includes use of Miconazole Oral gel for 14 days with frequency of four time per day.
CandBerrol® lozengesDietary supplement
Protocol for experimental groups includes use of Miconazole Oral gel and CandBerrol® lozenges for 14 days with frequency of four time per day
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects with acrylate dentures and oral Candida spp infection-Miconazole group | Active comparator | These group includes systematically healthy patients wearing acrylate dentures and with microbiologically confirmed oral infection caused with Candida spp.
These patients were treated with Miconazole gel. Receives: Drug: Miconazole |
| Healthy subjects with acrylate dentures and oral Candida spp infection-Candberrol-Miconazole group | Experimental | These group includes systematically healthy patients wearing acrylate dentures and with microbiologically confirmed oral infection caused with Candida spp.
These patients were treated with Miconazole gel and Candberrol lozenges. Receives: Drug: Miconazole; Dietary Supplement: CandBerrol® lozenges |
| Diabetic subjects without dentures and with oral Candida spp infection - Miconazole group | Active comparator | These group includes diabetes mellitus patients without acrylate dentures and with microbiologically confirmed oral infection caused with Candida spp.
These patients were treated with Miconazole gel. Receives: Drug: Miconazole |
| Diabetic subjects without dentures and with oral Candida spp infection - Miconazole-Candberrol group | Experimental | These group includes diabetes mellitus patients without acrylate dentures and with microbiologically confirmed oral infection caused with Candida spp.
These patients were treated with Miconazole gel and Candberrol lozenges. Receives: Drug: Miconazole; Dietary Supplement: CandBerrol® lozenges |
| Diabetic subjects with acrylate dentures and oral Candida spp - Miconazole group | Active comparator | These group includes diabetes mellitus patients with acrylate dentures and microbiologically confirmed oral infection caused with Candida spp.
These patients were treated with Miconazole gel. Receives: Drug: Miconazole |
| Diabetic subjects with acrylate dentures and oral Candida spp - Miconazole and Candberrol group | Experimental | These group includes diabetes mellitus patients with acrylate dentures and microbiologically confirmed oral infection caused with Candida spp.
These patients were treated with Miconazole gel and Candberrol lozenges. Receives: Drug: Miconazole; Dietary Supplement: CandBerrol® lozenges |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Candida albicans after therapy at first reexamination
Evaluation of symptoms and the presence of Candida spp. on day 18 from the beginning of the therapy
Measured: 1.5 year
Presence of Candida albicans after therapy at second reexamination
Evaluation of symptoms and the presence of Candida spp. on day 30 from the beginning of the therapy
Measured: 1.5 year
Presence of Candida albicans after therapy at third reexamination
Evaluation of symptoms and the presence of Candida spp. 4 days after the end of the therapy
Measured: 1.5 year
Presence of Candida albicans after therapy at fourth reexamination
Evaluation of symptoms and the presence of Candida spp. 12 days after the end of the therapy
Measured: 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start1 May 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral CandidiasesStudies 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Belgrade
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natasa Nikolic Jakoba, University of Belgrade
- Investigators
- Natasa Nikolic Jakoba, Principal investigator, University of Belgrade, School of Dental Medicine, Department of Periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05916729
- Sponsor's protocol ID
- UBelgrade 36/9
- Status last verified
- Jun 2023
- First submitted
- 11 Jun 2023
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "The Effect of Using Preparations With Maqui Berry Extract in Treating Oral Candidiasis in Patients With Diabetes Mellitus and Systemically Healthy Persons"
- ClinicalTrials.gov ID
- NCT05916729
- Acronym / sponsor ID
- UBelgrade 36/9
- Conditions
- Oral Candidiases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of BelgradeUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fungi from the genus Candida present the saprophytic flora of the cavity. This saprophytic yeast can cause different form of oral infections at immunocompromised patients as well as at subjects with impaired local oral microbiota e.g. wearers of dentures.
The most common cause of oral candidiasis is Candida albicans, but recently, non-albicans species has also been commonly isolated. One of the reasons for growing frequency of non-albicans species is traditional antifungal therapy. Standard antifungal therapy, which means elimination of yeasts, lead to antimicrobial resistance, dysbiosis and higher incidence of non-albicans species In order to overcome these limitations, the new antimicrobial therapy is based on anti-virulence strategy. This approach relays on disarming the microorganism, instead of killing or stopping their growth, which is especially important for saprophytes.
In case of Candida albicans the main goal is preventing transition from cell to hyphal form.
Detailed description
The aim of this study is to assess the efficiency of a dietary supplement based on Maqui Berry extract (CandBerrol® lozenge, Phytonet, Serbia) in treatment of oral candidiasis in patients who are treated with standard antifungal therapy - miconazole, 2%, (Daktanol® oral gel, Galenika, Serbia).
The study would be conducted at Clinic for Periodontology and Oral Medicine, School of Dental Medicine, University of Belgrade. The subjects would be recruited from the pool of patients who come for the treatment of suspected oral candidiasis.
A total of 90 patients with confirmed fungal infection (Candida spp.) of the oral cavity would be included in the study and divided into three groups (30 subjects per group), matched by gender and age:
Group A: systemically healthy subjects wearing acrylate dentures
Group B: subjects with diabetes mellitus without acrylate dentures
Group C: subjects with diabetes mellitus wearing acrylate dentures
Each group is further subdivided into two treatment subgroups:
- Active control, treated with miconazole, 2% (Daktanol® oral gel, Galenika, Serbia).
- Experimental, treated with miconazole, 2% with Maqui Berry extract (CandBerrol® lozenge, Phytonet, Serbia)
During the first examination, patients signed their consent to participate in the research based on written and oral information about the type, duration and expected outcome of the research. Following signing the consent, the research sheet specifically designed for this study would be fulfilled.
Both therapy protocol (active control and experimental therapy) would be administrated for 14 days. Therapy protocols would also include advices for oral and denture hygiene and diet. Clinical and microbiological controls would be conducted after 7th, 18th and 30th days from the start of therapy.
Patients who would not be able to follow the study instructions, would be excluded from the study.
Statistical analysis would be analyzed using the SPSS software program using appropriate statistical tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects with acrylate dentures and oral Candida spp infection-Miconazole group | Active comparator | Drug: MiconazoleThese group includes systematically healthy patients wearing acrylate dentures and with microbiologically confirmed oral infection caused with Candida spp. These patients were treated with Miconazole gel. |
| Healthy subjects with acrylate dentures and oral Candida spp infection-Candberrol-Miconazole group | Experimental | Drug: Miconazole, Dietary Supplement: CandBerrol® lozengesThese group includes systematically healthy patients wearing acrylate dentures and with microbiologically confirmed oral infection caused with Candida spp. These patients were treated with Miconazole gel and Candberrol lozenges. |
| Diabetic subjects without dentures and with oral Candida spp infection - Miconazole group | Active comparator | Drug: MiconazoleThese group includes diabetes mellitus patients without acrylate dentures and with microbiologically confirmed oral infection caused with Candida spp. These patients were treated with Miconazole gel. |
| Diabetic subjects without dentures and with oral Candida spp infection - Miconazole-Candberrol group | Experimental | Drug: Miconazole, Dietary Supplement: CandBerrol® lozengesThese group includes diabetes mellitus patients without acrylate dentures and with microbiologically confirmed oral infection caused with Candida spp. These patients were treated with Miconazole gel and Candberrol lozenges. |
| Diabetic subjects with acrylate dentures and oral Candida spp - Miconazole group | Active comparator | Drug: MiconazoleThese group includes diabetes mellitus patients with acrylate dentures and microbiologically confirmed oral infection caused with Candida spp. These patients were treated with Miconazole gel. |
| Diabetic subjects with acrylate dentures and oral Candida spp - Miconazole and Candberrol group | Experimental | Drug: Miconazole, Dietary Supplement: CandBerrol® lozengesThese group includes diabetes mellitus patients with acrylate dentures and microbiologically confirmed oral infection caused with Candida spp. These patients were treated with Miconazole gel and Candberrol lozenges. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age over 18
- Candida spp. infection (Clinical signs, symptoms and microbiological confirmation of infection)
- Systematically healthy wearing acrylate denture (Group A)
- Diabetic patients with/without acrylate denture (Groups B and C)
Key exclusion criteria (2 listed)
- Presence of other systemic diseases
- Presence other oral mucosal contions
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 |
|---|---|---|
| MiconazoleAlso: Daktanol®Protocol for active control groups includes use of Miconazole Oral gel for 14 days with frequency of four time per day. | Drug | Diabetic subjects with acrylate dentures and oral Candida spp - Miconazole and Candberrol group, Diabetic subjects with acrylate dentures and oral Candida spp - Miconazole group, Diabetic subjects without dentures and with oral Candida spp infection - Miconazole group, Diabetic subjects without dentures and with oral Candida spp infection - Miconazole-Candberrol group, Healthy subjects with acrylate dentures and oral Candida spp infection-Candberrol-Miconazole group, Healthy subjects with acrylate dentures and oral Candida spp infection-Miconazole group |
| CandBerrol® lozengesProtocol for experimental groups includes use of Miconazole Oral gel and CandBerrol® lozenges for 14 days with frequency of four time per day | Dietary supplement | Diabetic subjects with acrylate dentures and oral Candida spp - Miconazole and Candberrol group, Diabetic subjects without dentures and with oral Candida spp infection - Miconazole-Candberrol group, Healthy subjects with acrylate dentures and oral Candida spp infection-Candberrol-Miconazole group |
Primary outcome
Presence of Candida albicans after therapy at first reexamination
Time frame: 1.5 year
Evaluation of symptoms and the presence of Candida spp. on day 18 from the beginning of the therapy
Presence of Candida albicans after therapy at second reexamination
Time frame: 1.5 year
Evaluation of symptoms and the presence of Candida spp. on day 30 from the beginning of the therapy
Presence of Candida albicans after therapy at third reexamination
Time frame: 1.5 year
Evaluation of symptoms and the presence of Candida spp. 4 days after the end of the therapy
Presence of Candida albicans after therapy at fourth reexamination
Time frame: 1.5 year
Evaluation of symptoms and the presence of Candida spp. 12 days after the end of the therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
Related trials for Oral Candidiases
RecruitingPhase 3
A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.
Candidemia, Candidiasis, Invasive
RecruitingObservational study
Safety of Pregnant Subjects Exposed to Ibrexafungerp Including Infant Outcomes
Vulvovaginitis, Candidal, Vulvovaginal Candidiasis
Not yet recruiting
Improving Prescribing Quality for Oral Mucosal Disorders Using a Pharmacist-Led Model
Oral Lichen Planus, Recurrent Aphthous Stomatitis
RecruitingObservational study
Oropharyngeal Candidiasis (OPC) and S-ECC
Candida Infection, Oral Thrush
RecruitingPhase 4
Posaconazole Pharmacokinetics in Patients Receiving Chemotherapy or Stem Cell Transplants
Posaconazole, Pharmacokinetics
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.
Natasa Nikolic Jakoba principal investigator
University of Belgrade, School of Dental Medicine, Department of Periodontology
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 Miconazole and CandBerrol® lozenges in people with Oral Candidiases, run by University of Belgrade at 1 site in Serbia.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 23 Jun 2023. 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 Serbia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natasa Nikolic Jakoba (+381638269909, natasa.nikolic.jakoba@stomf.bg.ac.rs), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Candida albicans after therapy at first reexamination (time frame: 1.5 year). The study lists 4 primary outcomes in all. 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 23 Jun 2023.