Clinical trial NCT05916729: Use of Maqui Berry Extract in Treating Oral Candidiasis in Diabetes Mellitus Patients and Systemically Healthy Persons
Official title: "The Effect of Using Preparations With Maqui Berry Extract in Treating Oral Candidiasis in Patients With Diabetes Mellitus and Systemically Healthy Persons"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Oral Candidiases
Lead sponsor: University of Belgrade
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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:

1. Active control, treated with miconazole, 2% (Daktanol® oral gel, Galenika, Serbia).
2. 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* Presence of other systemic diseases
* Presence other oral mucosal contions

Primary outcomes:
measure: Presence of Candida albicans after therapy at first reexamination
timeFrame: 1.5 year
measure: Presence of Candida albicans after therapy at second reexamination
timeFrame: 1.5 year
measure: Presence of Candida albicans after therapy at third reexamination
timeFrame: 1.5 year
measure: Presence of Candida albicans after therapy at fourth reexamination
timeFrame: 1.5 year
Secondary outcomes:
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Natasa Nikolic Jakoba
Study officials:
affiliation: University of Belgrade, School of Dental Medicine, Department of Periodontology
name: Natasa Nikolic Jakoba
role: PRINCIPAL_INVESTIGATOR
References: