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

NCT05916729 | Unknown Phase 4

• 1 other identifier: UBelgrade 36/9
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Candidiases

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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

  1.5 year

Study Arms (6)

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.

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.

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.

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.

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.

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.

Drug: Miconazole; Dietary Supplement: CandBerrol® lozenges

Interventions

Miconazole DRUG

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®

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® lozenges DIETARY_SUPPLEMENT

Protocol for experimental groups includes use of Miconazole Oral gel and CandBerrol® lozenges for 14 days with frequency of four time per day

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University of Belgrade: lead

Study Sites (1)

Natasa Nikolic Jakoba

Belgrade, Serbia

RECRUITING

MeSH Terms

Conditions

Candidiasis, Oral

Interventions

Miconazole

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Natasa Nikolic Jakoba

  University of Belgrade, School of Dental Medicine, Department of Periodontology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natasa Nikolic Jakoba

CONTACT

+381638269909; natasa.nikolic.jakoba@stomf.bg.ac.rs

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof.

Study Record Dates

• First Submitted: June 11, 2023
• First Posted: June 23, 2023
• Study Start: May 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: January 1, 2025
• Last Updated: June 23, 2023

Record last verified: 2023-06

Locations

SE (1)