Velphoro and Impact on the Oral Cavity and Gut Microbiome

Study Overview
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Brief Summary
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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
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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.

Official Title
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Velphoro and Impact on the Oral Cavity and Gut Microbiome

Conditions
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Hyperphosphatemia

Intervention / Treatment
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* Drug: Velphoro
* Other: saliva collection
* Other: Supragingival biofilm collection
* Other: stool collection
* Other: blood collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| hemodialysis patients with hyperphosphatemia<br>dental investigation and two sample collections of saliva, gingival biofilm (plaque) and stool Velphoro® medication | Drug: Velphoro<br>* 4 weeks<br>* Other names: Sucroferric oxyhydroxide;Other: saliva collection<br>* 2 samples<br>Other: Supragingival biofilm collection<br>* 2 samples<br>* Other names: plaque;Other: stool collection<br>* 2 samples<br>Other: blood collection<br>* 2 samples<br>|
| control group<br>- dental investigation and two sample collections of saliva, gingival biofilm (plaque) and stool | Other: saliva collection<br>* 2 samples<br>Other: Supragingival biofilm collection<br>* 2 samples<br>* Other names: plaque;Other: stool collection<br>* 2 samples<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in relative abundances of iron depending bacterial species within the microbiome from before Velphoro medication to afterwards |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of distribution of bacterial species within the microbiome from baseline to after Velphoro medication | via diversity measure | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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microbiome