Velphoro and Impact on the Oral Cavity and Gut Microbiome
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- change in relative abundances of iron depending bacterial species within the microbiome from before Velphoro medication to afterwards
研究概览
简要总结
This pilot study will be carried out to determine if the regular intake of iron-based Velphoro® by hyperphosphatemia patients influences the microbiome in the oral cavity and/or the gut.
详细描述
The aim of this study is to investigate potential changes in the microbiome of the oral cavity and/or gut in patients with hyperphosphatemia following Velphoro® intake for one month. The principal intention of this study is to assess consequences of Velphoro® medication beyond phosphate control. Adherence to the drug might be compromised by e.g. staining of teeth and biofilm after chewing the product more than recommended. Most likely this is a cosmetic problem only and easy to solve by optimizing oral hygiene. The increased level of iron may have an effect on the gut microbiome which could lead to mild diarrhoea. However, the present study will assess, whether the microbiome both oral and gut changes significantly due to some iron bio-availability, although this is expected to be low with sucroferric oxyhydroxide.
The ultimate goal is to improve patient adherence to the drug and to resolve potential safety concerns.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Suffering from hyperphosphatemia
- •Current treatment with a stable dose of a non-iron containing phosphate binder,
- •No or only parenteral iron application
- •Age of ≥ 18 years
- •Written informed consent prior to study participation
- •The subject is willing and able to follow the procedures outlined in the protocol
- •Control group:
- •Normal renal function
- •No hyperphosphatemia
- •Age- and sex-matched and oral disease status-matched (dental caries and periodontal disease) in comparison to the hyperphosphatemia group
- •Written informed consent prior to study participation
- •The subject is willing and able to follow the procedures outlined in the protocol
排除标准
- •Age less than 18 years
- •Currently on oral iron application
- •Antibiotic treatment within the last two months
- •Severe medical events within the last three months
- •Planned surgery for the duration of the sampling
- •Acute/chronic gastrointestinal infections
- •Oral candidiasis
- •Oral cancer
- •Pregnant and lactating females
- •Haemochromatosis history
- •Committed to an institution by legal or regulatory order
- •Participation in a parallel interventional clinical trial
- •Receipt of an investigational drug within 30 days prior to inclusion into this study
- •The subject is mentally or legally incapacitated
- •Only for the patient group:
- •Never got any phosphate binder
- •Allergy to Velphoro®
- •Celiac disease or any other chronic inflammatory bowel disease
- •Previous major surgery in the gastrointestinal tract
研究组 & 干预措施
hemodialysis patients with hyperphosphatemia
- dental investigation and two sample collections of saliva, gingival biofilm (plaque) and stool
- Velphoro® medication
干预措施: Velphoro (Drug)
hemodialysis patients with hyperphosphatemia
- dental investigation and two sample collections of saliva, gingival biofilm (plaque) and stool
- Velphoro® medication
干预措施: saliva collection (Other)
hemodialysis patients with hyperphosphatemia
- dental investigation and two sample collections of saliva, gingival biofilm (plaque) and stool
- Velphoro® medication
干预措施: Supragingival biofilm collection (Other)
hemodialysis patients with hyperphosphatemia
- dental investigation and two sample collections of saliva, gingival biofilm (plaque) and stool
- Velphoro® medication
干预措施: stool collection (Other)
hemodialysis patients with hyperphosphatemia
- dental investigation and two sample collections of saliva, gingival biofilm (plaque) and stool
- Velphoro® medication
干预措施: blood collection (Other)
control group
- dental investigation and two sample collections of saliva, gingival biofilm (plaque) and stool
干预措施: saliva collection (Other)
control group
- dental investigation and two sample collections of saliva, gingival biofilm (plaque) and stool
干预措施: Supragingival biofilm collection (Other)
control group
- dental investigation and two sample collections of saliva, gingival biofilm (plaque) and stool
干预措施: stool collection (Other)
结局指标
主要结局
change in relative abundances of iron depending bacterial species within the microbiome from before Velphoro medication to afterwards
时间窗: 4 weeks
次要结局
- Change of distribution of bacterial species within the microbiome from baseline to after Velphoro medication(4 weeks)