HyperphosphatemiaMicrobiomEisenNCT03409757
Velphoro and Impact on the Oral Cavity and Gut Microbiome
An observational study of Hyperphosphatemia, run by RWTH Aachen University at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyperphosphatemia
- What is being tested?
- Velphoro, saliva collection and Supragingival biofilm collection
- How many people
- 22 participants
- Where
- 1 siteGermany
- Study dates
- 28 Feb 2018to 6 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older 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
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital of RWTH Aachen, Department of Medicine II
Aachen
About this study
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.
Read the 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.
- Conditions
- Hyperphosphatemia
- Being tested
- Velphoro, saliva collection, Supragingival biofilm collection, stool collection, blood collection
- Keywords
- microbiome
- Medical subject headings
- Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VelphoroDrug
Also called Sucroferric oxyhydroxide
4 weeks
saliva collectionOther
2 samples
Supragingival biofilm collectionOther
Also called plaque
2 samples
stool collectionOther
2 samples
blood collectionOther
2 samples
| Study group | Role | What they receive |
|---|---|---|
| hemodialysis patients with hyperphosphatemia | * dental investigation and two sample collections of saliva, gingival biofilm (plaque) and stool
* Velphoro® medication Receives: 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 Receives: Other: saliva collection; Other: Supragingival biofilm collection; Other: stool collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in relative abundances of iron depending bacterial species within the microbiome from before Velphoro medication to afterwards
Measured: 4 weeks
Secondary outcomes (1)
Change of distribution of bacterial species within the microbiome from baseline to after Velphoro medication
via diversity measure
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start28 Feb 2018
- Primary completion6 Oct 2020
- Study completion6 Oct 2020
Why it stopped: Insufficient Patient Recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperphosphatemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03409757
- Sponsor's protocol ID
- 16-058
- Acronym
- MicrobiomEisen
- Status last verified
- Nov 2020
- First submitted
- 5 Dec 2017
- Last updated
- 25 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Velphoro and Impact on the Oral Cavity and Gut Microbiome
- ClinicalTrials.gov ID
- NCT03409757
- Acronym / sponsor ID
- MicrobiomEisen / 16-058
- Conditions
- Hyperphosphatemia
- Keywords
- microbiome
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient Patient Recruitment
- Enrolment
- 22 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 28 Feb 2018 (actual)
- Primary completion
- 6 Oct 2020 (actual)
- Study completion
- 6 Oct 2020 (actual)
- First posted
- 24 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hemodialysis patients with hyperphosphatemia | – | Drug: Velphoro, Other: saliva collection, Other: Supragingival biofilm collection, Other: stool collection, Other: blood collection* dental investigation and two sample collections of saliva, gingival biofilm (plaque) and stool * Velphoro® medication |
| control group | – | Other: saliva collection, Other: Supragingival biofilm collection, Other: stool collection- dental investigation and two sample collections of saliva, gingival biofilm (plaque) and stool |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VelphoroAlso: Sucroferric oxyhydroxide4 weeks | Drug | hemodialysis patients with hyperphosphatemia |
| saliva collection2 samples | Other | control group, hemodialysis patients with hyperphosphatemia |
| Supragingival biofilm collectionAlso: plaque2 samples | Other | control group, hemodialysis patients with hyperphosphatemia |
| stool collection2 samples | Other | control group, hemodialysis patients with hyperphosphatemia |
| blood collection2 samples | Other | hemodialysis patients with hyperphosphatemia |
Primary outcome
change in relative abundances of iron depending bacterial species within the microbiome from before Velphoro medication to afterwards
Time frame: 4 weeks
1 secondary outcome
Change of distribution of bacterial species within the microbiome from baseline to after Velphoro medication
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: Insufficient Patient Recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperphosphatemia, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient Patient Recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in relative abundances of iron depending bacterial species within the microbiome from before Velphoro medication to afterwards (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2020.