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

June 20, 2023 updated by: Natasa Nikolic Jakoba, University of Belgrade

"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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Healthy subjects with acrylate dentures and oral Candida spp infection-Miconazole group

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
Protocol for active control groups includes use of Miconazole Oral gel for 14 days with frequency of four time per day.
Other Names:
  • Daktanol®
Experimental: Healthy subjects with acrylate dentures and oral Candida spp infection-Candberrol-Miconazole group

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
Protocol for active control groups includes use of Miconazole Oral gel for 14 days with frequency of four time per day.
Other Names:
  • Daktanol®
Dietary supplement: CandBerrol® lozenges
Protocol for experimental groups includes use of Miconazole Oral gel and CandBerrol® lozenges for 14 days with frequency of four time per day
Active Comparator: Diabetic subjects without dentures and with oral Candida spp infection - Miconazole group

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
Protocol for active control groups includes use of Miconazole Oral gel for 14 days with frequency of four time per day.
Other Names:
  • Daktanol®
Experimental: Diabetic subjects without dentures and with oral Candida spp infection - Miconazole-Candberrol group

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
Protocol for active control groups includes use of Miconazole Oral gel for 14 days with frequency of four time per day.
Other Names:
  • Daktanol®
Dietary supplement: CandBerrol® lozenges
Protocol for experimental groups includes use of Miconazole Oral gel and CandBerrol® lozenges for 14 days with frequency of four time per day
Active Comparator: Diabetic subjects with acrylate dentures and oral Candida spp - Miconazole group

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
Protocol for active control groups includes use of Miconazole Oral gel for 14 days with frequency of four time per day.
Other Names:
  • Daktanol®
Experimental: Diabetic subjects with acrylate dentures and oral Candida spp - Miconazole and Candberrol group

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
Protocol for active control groups includes use of Miconazole Oral gel for 14 days with frequency of four time per day.
Other Names:
  • Daktanol®
Dietary supplement: CandBerrol® lozenges
Protocol for experimental groups includes use of Miconazole Oral gel and CandBerrol® lozenges for 14 days with frequency of four time per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1.5 year
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
1.5 year
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
1.5 year
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
1.5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Belgrade

Investigators

  • Principal Investigator: Natasa Nikolic Jakoba, University of Belgrade, School of Dental Medicine, Department of Periodontology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

June 11, 2023

First Submitted That Met QC Criteria

June 20, 2023

First Posted (Actual)

June 23, 2023

Study Record Updates

Last Update Posted (Actual)

June 23, 2023

Last Update Submitted That Met QC Criteria

June 20, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UBelgrade 36/9

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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