Ignite Creation Date:
2024-05-06 @ 7:09 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05916729
Status:
RECRUITING
Last Update Posted:
2023-06-23
First Post:
2023-06-11
Brief Title:
Use of Maqui Berry Extract in Treating Oral Candidiasis in Diabetes Mellitus Patients and Systemically Healthy Persons
Sponsor:
University of Belgrade
Organization:
University of Belgrade
Study Overview
Official Title:
The Effect of Using Preparations With Maqui Berry Extract in Treating Oral Candidiasis in Patients With Diabetes Mellitus and Systemically Healthy Persons
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None