Velphoro and Impact on the Oral Cavity and Gut Microbiome

Hyperphosphatemia Clinical Trial

— MicrobiomEisen  

Official title:

Velphoro and Impact on the Oral Cavity and Gut Microbiome

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03409757
• Other study ID #: 16-058
• Status: Terminated
• Start date: February 28, 2018
• Est. completion date: October 6, 2020

Study information

• Verified date: November 2020
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: October 6, 2020
• Est. primary completion date: October 6, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperphosphatemia

Intervention

Drug:
• Velphoro
4 weeks

Other:
• saliva collection
2 samples
• Supragingival biofilm collection
2 samples
• stool collection
2 samples
• blood collection
2 samples

Locations

Country	Name	City	State
Germany	University Hospital of RWTH Aachen, Department of Medicine II	Aachen

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in relative abundances of iron depending bacterial species within the microbiome from before Velphoro medication to afterwards		4 weeks
Secondary	Change of distribution of bacterial species within the microbiome from baseline to after Velphoro medication	via diversity measure	4 weeks