Velphoro and Impact on the Oral Cavity and Gut Microbiome | NCT03409757

Studies
Velphoro and Impact on the Oral Cavity and Gut Microbiome

NCT03409757

Sponsor

RWTH Aachen University

Status

Terminated

Last Update Posted

Nov 25, 2020Actual

Enrollment

22Actual

Phase

Not provided

Conditions

Hyperphosphatemia

Interventions

Velphoro
saliva collection
Supragingival biofilm collection
stool collection
blood collection

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Insufficient Patient Recruitment

Expanded Access Info

Start Date

Feb 28, 2018Actual

Primary Completion Date

Oct 6, 2020Actual

Completion Date

Oct 6, 2020Actual

First Submitted Date

Dec 5, 2017

First Submission Date that Met QC Criteria

Jan 17, 2018

First Posted Date

Jan 24, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 23, 2020

Last Update Posted Date

Nov 25, 2020Actual

Description Module

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 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
hemodialysis patients with hyperphosphatemia		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
control group		- dental investigation and two sample collections of saliva, gingival biofilm (plaque) and stool	Other: saliva collection Other: Supragingival biofilm collection Other: stool collection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Velphoro	Drug	4 weeks	hemodialysis patients with hyperphosphatemia

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Probability Sample

ID	Term
D010760	Phosphorus Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
C000599459	sucroferric oxyhydroxide
D057968	Transdermal Patch
D001800	Blood Specimen Collection

ID	Term
D004864	Equipment and Supplies
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures