Velphoro and Impact on the Oral Cavity and Gut Microbiome (MicrobiomEisen)

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.

Study Overview

• Status: Terminated
• Conditions: Hyperphosphatemia
• Intervention / Treatment: Drug: Velphoro; Other: saliva collection; Other: Supragingival biofilm collection; Other: stool collection; Other: blood collection

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 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.

• Study Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

• Germany
  • Aachen, Germany
    • University Hospital of RWTH Aachen, Department of Medicine II

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: RWTH Aachen University

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2018
• Primary Completion (Actual): October 6, 2020
• Study Completion (Actual): October 6, 2020

Study Registration Dates

• First Submitted: December 5, 2017
• First Submitted That Met QC Criteria: January 17, 2018
• First Posted (Actual): January 24, 2018

Study Record Updates

• Last Update Posted (Actual): November 25, 2020
• Last Update Submitted That Met QC Criteria: November 23, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: microbiome
• Additional Relevant MeSH Terms: Metabolic Diseases; Phosphorus Metabolism Disorders; Hyperphosphatemia
• Other Study ID Numbers: 16-058

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No