An observational study in Hyperphosphatemia, sponsored by RWTH Aachen University. Terminated at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-25.
Sponsored by RWTH Aachen University · Observational
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.
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.
hemodialysis patients suffering from hyperphosphatemia and healthy volunteers from the clinical routine in the Department of Operative Dentistry, Periodontology and Preventive Dentistry at the university hospital RWTH Aachen
Control group:
Exclusion Criteria:
Only for the patient group:
* dental investigation and two sample collections of saliva, gingival biofilm (plaque) and stool * Velphoro® medication
Drug: Velphoro · Other: saliva collection · Other: Supragingival biofilm collection · Other: stool collection · Other: blood collection
- dental investigation and two sample collections of saliva, gingival biofilm (plaque) and stool
Other: saliva collection · Other: Supragingival biofilm collection · Other: stool collection
4 weeks
Also known as: Sucroferric oxyhydroxide
2 samples
2 samples
Also known as: plaque
2 samples
2 samples
change in relative abundances of iron depending bacterial species within the microbiome from before Velphoro medication to afterwards
Time frame: 4 weeks
Change of distribution of bacterial species within the microbiome from baseline to after Velphoro medication
via diversity measure
Time frame: 4 weeks
This study is terminated, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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RWTH Aachen University