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Velphoro and Impact on the Oral Cavity and Gut Microbiome

NCT ID: NCT03409757

Last Updated: 2020-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-28

Study Completion Date

2020-10-06

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.

Conditions

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Hyperphosphatemia

Keywords

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microbiome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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hemodialysis patients with hyperphosphatemia

* dental investigation and two sample collections of saliva, gingival biofilm (plaque) and stool
* Velphoro® medication

Velphoro

Intervention Type DRUG

4 weeks

saliva collection

Intervention Type OTHER

2 samples

Supragingival biofilm collection

Intervention Type OTHER

2 samples

stool collection

Intervention Type OTHER

2 samples

blood collection

Intervention Type OTHER

2 samples

control group

\- dental investigation and two sample collections of saliva, gingival biofilm (plaque) and stool

saliva collection

Intervention Type OTHER

2 samples

Supragingival biofilm collection

Intervention Type OTHER

2 samples

stool collection

Intervention Type OTHER

2 samples

Interventions

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Velphoro

4 weeks

Intervention Type DRUG

saliva collection

2 samples

Intervention Type OTHER

Supragingival biofilm collection

2 samples

Intervention Type OTHER

stool collection

2 samples

Intervention Type OTHER

blood collection

2 samples

Intervention Type OTHER

Other Intervention Names

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Sucroferric oxyhydroxide plaque

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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RWTH Aachen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital of RWTH Aachen, Department of Medicine II

Aachen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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16-058

Identifier Type: -

Identifier Source: org_study_id