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MicrobiomEisen: Velphoro and Impact on the Oral Cavity and Gut Microbiome

Sponsor
RWTH Aachen University (Other)
Overall Status
Terminated
CT.gov ID
NCT03409757
Collaborator
(none)
22
Enrollment
1
Location
31.2
Actual Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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 Design

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 :
Feb 28, 2018
Actual Primary Completion Date :
Oct 6, 2020
Actual Study Completion Date :
Oct 6, 2020

Arms and Interventions

Arm 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

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

    1. Change of distribution of bacterial species within the microbiome from baseline to after Velphoro medication [4 weeks]

      via diversity measure

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital of RWTH Aachen, Department of Medicine II Aachen Germany

    Sponsors and Collaborators

    • RWTH Aachen University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    RWTH Aachen University
    ClinicalTrials.gov Identifier:
    NCT03409757
    Other Study ID Numbers:
    • 16-058
    First Posted:
    Jan 24, 2018
    Last Update Posted:
    Nov 25, 2020
    Last Verified:
    Nov 1, 2020
    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:
    Hyperphosphatemia

    Study Results

    No Results Posted as of Nov 25, 2020