"The Effect of Using Preparations With Maqui Berry Extract in Treating Oral Candidiasis in Patients With Diabetes Mellitus and Systemically Healthy Persons"
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Presence of Candida albicans after therapy at first reexamination
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Presence of other systemic diseases
- •Presence other oral mucosal contions
研究组 & 干预措施
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.
干预措施: CandBerrol® lozenges (Dietary Supplement)
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.
干预措施: Miconazole (Drug)
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.
干预措施: Miconazole (Drug)
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.
干预措施: Miconazole (Drug)
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.
干预措施: Miconazole (Drug)
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.
干预措施: CandBerrol® lozenges (Dietary Supplement)
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.
干预措施: Miconazole (Drug)
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.
干预措施: Miconazole (Drug)
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.
干预措施: CandBerrol® lozenges (Dietary Supplement)
结局指标
主要结局
Presence of Candida albicans after therapy at first reexamination
时间窗: 1.5 year
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 third reexamination
时间窗: 1.5 year
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
时间窗: 1.5 year
Evaluation of symptoms and the presence of Candida spp. 12 days after the end of the therapy
Presence of Candida albicans after therapy at second reexamination
时间窗: 1.5 year
Evaluation of symptoms and the presence of Candida spp. on day 30 from the beginning of the therapy
次要结局
未报告次要终点
研究者
Natasa Nikolic Jakoba
Assist. Prof.
University of Belgrade