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Use of Maqui Berry Extract in Treating Oral Candidiasis in Diabetes Mellitus Patients and Systemically Healthy Persons

Primary Purpose

Oral Candidiases

Status
Recruiting
Phase
Phase 4
Locations
Serbia
Study Type
Interventional
Intervention
Miconazole
CandBerrol® lozenges
Sponsored by
University of Belgrade
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Candidiases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Natasa Nikolic JakobaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

Healthy subjects with acrylate dentures and oral Candida spp infection-Miconazole group

Healthy subjects with acrylate dentures and oral Candida spp infection-Candberrol-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

Diabetic subjects with acrylate dentures and oral Candida spp - Miconazole group

Diabetic subjects with acrylate dentures and oral Candida spp - Miconazole and Candberrol group

Arm Description

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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
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
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
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

Secondary Outcome Measures

Full Information

First Posted
June 11, 2023
Last Updated
June 20, 2023
Sponsor
University of Belgrade
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1. Study Identification

Unique Protocol Identification Number
NCT05916729
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Belgrade

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Candidiases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy subjects with acrylate dentures and oral Candida spp infection-Miconazole group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Healthy subjects with acrylate dentures and oral Candida spp infection-Candberrol-Miconazole group
Arm Type
Experimental
Arm Description
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.
Arm Title
Diabetic subjects without dentures and with oral Candida spp infection - Miconazole group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Diabetic subjects without dentures and with oral Candida spp infection - Miconazole-Candberrol group
Arm Type
Experimental
Arm Description
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.
Arm Title
Diabetic subjects with acrylate dentures and oral Candida spp - Miconazole group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Diabetic subjects with acrylate dentures and oral Candida spp - Miconazole and Candberrol group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Miconazole
Other Intervention Name(s)
Daktanol®
Intervention Description
Protocol for active control groups includes use of Miconazole Oral gel for 14 days with frequency of four time per day.
Intervention Type
Dietary Supplement
Intervention Name(s)
CandBerrol® lozenges
Intervention Description
Protocol for experimental groups includes use of Miconazole Oral gel and CandBerrol® lozenges for 14 days with frequency of four time per day
Primary Outcome Measure Information:
Title
Presence of Candida albicans after therapy at first reexamination
Description
Evaluation of symptoms and the presence of Candida spp. on day 18 from the beginning of the therapy
Time Frame
1.5 year
Title
Presence of Candida albicans after therapy at second reexamination
Description
Evaluation of symptoms and the presence of Candida spp. on day 30 from the beginning of the therapy
Time Frame
1.5 year
Title
Presence of Candida albicans after therapy at third reexamination
Description
Evaluation of symptoms and the presence of Candida spp. 4 days after the end of the therapy
Time Frame
1.5 year
Title
Presence of Candida albicans after therapy at fourth reexamination
Description
Evaluation of symptoms and the presence of Candida spp. 12 days after the end of the therapy
Time Frame
1.5 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Natasa Nikolic Jakoba
Phone
+381638269909
Email
natasa.nikolic.jakoba@stomf.bg.ac.rs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natasa Nikolic Jakoba
Organizational Affiliation
University of Belgrade, School of Dental Medicine, Department of Periodontology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Natasa Nikolic Jakoba
City
Belgrade
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natasa Nikolic Jakoba
Phone
+381638269909
Email
natasa.nikolic.jakoba@stomf.bg.ac.rs

12. IPD Sharing Statement

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Use of Maqui Berry Extract in Treating Oral Candidiasis in Diabetes Mellitus Patients and Systemically Healthy Persons

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