A Phase 4 interventional study of Miconazole and CandBerrol® lozenges in Oral Candidiases, sponsored by University of Belgrade. Recruiting at 1 site in Serbia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-23.
Sponsored by University of Belgrade · Phase 4, Interventional, and Treatment
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.
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:
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.
48 studies on the registry are indexed under Candidiasis, Oral; 6 are open to participants now.
This study's planned enrollment of 90 is above the median of 70 across 32 interventional studies indexed under Candidiasis, Oral.
Browse Candidiasis, Oral studies →University of Belgrade is the lead sponsor of 72 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
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.
Drug: Miconazole
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.
Drug: Miconazole · Dietary Supplement: CandBerrol® lozenges
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.
Drug: Miconazole
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.
Drug: Miconazole · Dietary Supplement: CandBerrol® lozenges
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.
Drug: Miconazole
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.
Drug: Miconazole · Dietary Supplement: CandBerrol® lozenges
Protocol for active control groups includes use of Miconazole Oral gel for 14 days with frequency of four time per day.
Also known as: Daktanol®
Protocol for experimental groups includes use of Miconazole Oral gel and CandBerrol® lozenges for 14 days with frequency of four time per day
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 1.5 year
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University of Belgrade