Status:
TERMINATED
Velphoro and Impact on the Oral Cavity and Gut Microbiome
Lead Sponsor:
RWTH Aachen University
Conditions:
Hyperphosphatemia
Eligibility:
All Genders
18+ years
Brief Summary
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.
Detailed Description
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 int...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Smokers
- 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
Key Trial Info
Start Date :
February 28 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 6 2020
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03409757
Start Date
February 28 2018
End Date
October 6 2020
Last Update
November 25 2020
Active Locations (1)
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1
University Hospital of RWTH Aachen, Department of Medicine II
Aachen, Germany