Velphoro and impact on the oral cavity and gut microbiome

Phase 1

• Conditions: Hyperphosphatemia; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2017-003240-20-DE
• Lead Sponsor: RWTH Aachen, represented by the rector, himself represented by the dean of the Medical Faculty

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-14
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Patients:
•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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

Exclusion Criteria

•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:
•Allergy to Velphoro®
•Never got any phosphate binder
•Celiac disease or any other chronic inflammatory bowel disease
•Previous major surgery in the gastrointestinal tract

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Determination of abundances and relative frequencies of distinct bacteria in the collected samples from patients and the control group. Based on these data, potential shifts in the microbiome during Velphoro® medication will be assessed.;Secondary Objective: Determination of diversity measures describing the distribution of bacterial species within the microbiome (i. e. alpha-diversity, beta-diversity, Simpson index, Shannon-Wiener index), as well as the presence or absence of other medically relevant bacterial species (e,g, Pseudomonas, Enterobacteriaceae, Campylobacter etc.).;Primary end point(s): A significant shift (non-parametric Mann-Whitney-U test) in the relative abundance of iron-depending bacterial species will reject the 0-hypothesis;Timepoint(s) of evaluation of this end point: screening, 1 week, 4 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -A significant shift in total bacterial cell numbers<br>-A significant shift in species diversity<br>-A significant change in clinical parameters, including dental.<br>;Timepoint(s) of evaluation of this end point: screening, 1 week, 4 weeks