Velphoro and impact on the oral cavity and gut microbiome - Microbiom-Eisen

RWTH Aachen, represented by the rector, himself represented by the dean of the Medical Faculty0 个研究点目标入组 24 人开始时间: 2017年9月14日最近更新: 2020年11月9日

适应症

试验速览

暂无简介。

•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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 24
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 24

•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:
•Allergy to Velphoro®
•Never got any phosphate binder
•Celiac disease or any other chronic inflammatory bowel disease
•Previous major surgery in the gastrointestinal tract

发起方

RWTH Aachen, represented by the rector, himself represented by the dean of the Medical Faculty