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

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ClinicalTrials.gov Identifier: NCT03409757
Recruitment Status : Terminated (Insufficient Patient Recruitment)
First Posted : January 24, 2018
Last Update Posted : November 25, 2020
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University

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.

Condition or disease Intervention/treatment
Hyperphosphatemia 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.

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Study Type : Observational
Actual Enrollment : 22 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Velphoro and Impact on the Oral Cavity and Gut Microbiome
Actual Study Start Date : February 28, 2018
Actual Primary Completion Date : October 6, 2020
Actual Study Completion Date : October 6, 2020

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 Name: Sucroferric oxyhydroxide

Other: saliva collection
2 samples

Other: Supragingival biofilm collection
2 samples
Other Name: 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 Name: plaque

Other: stool collection
2 samples




Primary Outcome Measures :
  1. change in relative abundances of iron depending bacterial species within the microbiome from before Velphoro medication to afterwards [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Change of distribution of bacterial species within the microbiome from baseline to after Velphoro medication [ Time Frame: 4 weeks ]
    via diversity measure


Biospecimen Retention:   Samples With DNA
gingival biofilm, saliva and stool


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03409757


Locations
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Germany
University Hospital of RWTH Aachen, Department of Medicine II
Aachen, Germany
Sponsors and Collaborators
RWTH Aachen University
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Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT03409757    
Other Study ID Numbers: 16-058
First Posted: January 24, 2018    Key Record Dates
Last Update Posted: November 25, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by RWTH Aachen University:
microbiome
Additional relevant MeSH terms:
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Hyperphosphatemia
Phosphorus Metabolism Disorders
Metabolic Diseases