Intestinal Microbiota and Vitamin K Levels in PXE Patients (IMPROVE Study) (IMPROVE)

January 31, 2019 updated by: University Hospital, Angers
This study aims to demonstrate a potential association between gut microbiota composition, plasma levels of various forms of vitamin K, and severity of clinical manifestations of Pseudoxanthoma Elasticum (PXE).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Vitamin K deficiency contributes to pathological calcification which underlies the clinical picture of pseudoxanthoma elasticum (PXE), an inherited autosomal recessive disease. A substantial proportion of vitamin K, namely the K2 form (menaquinones), is produced by gut microbiota. In healthy volunteers fecal levels of the major menaquinone producers, Escherichia coli and Bacteroides species, are approximately 5 and 9 log10 CFU/g dry weight respectively. There is however a lack of data on gut microbiota in PXE patients. The objective of our project is to demonstrate a potential association between gut microbiota composition, plasma levels of various forms of vitamin K and severity of clinical manifestations in PXE patients.

This study will be performed as Research surrounding bio collection "Clinical and biological exploration of PXE patients" kept at the Center of Biological Resources of Angers University Hospital (bio collection n° DC 20116-14-67, authorization to transfer n° 2016-27-99). Fecal samples, plasma samples and clinical data will be collected from patients diagnosed with PXE who will be monitored at the Angers University Hospital Referral Center (France) in 2019-2020. Clinical severity of PXE will be assessed using modified Phenodex score. Gut microbiota will be analyzed using metagenomic sequencing. Plasma Vitamin K species and fecal excretion of menaquinones will be assessed using HPLC. Plasma dp-ucMGP (circulating biomarker of vitamin K status) and serum PIVKA-II (protein induced by vitamin K absence-II) will be assessed using immunoassay. Results will be compared to healthy age- and gender-matched controls from the pre-existing Biofortis database.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Pays De La Loire
      • Saint-Herblain, Pays De La Loire, France, 44800
        • Active, not recruiting
        • Biofortis Mérieux NutriSciences
    • Pays De Loire
      • Angers, Pays De Loire, France, 49933
        • Recruiting
        • Department of Dermatology, University Hospital of Angers
        • Contact:
  • Netherlands
      • Maastricht, Netherlands, 6229
        • Active, not recruiting
        • Department of Biochemistry, University Maastricht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with phenotypically and genetically (ABCC6) proven PXE
  • Aged over 18 years
  • Written consent obtained for Angers University Hospital (France) PXE bio-collection

Exclusion Criteria:

  • Patients under the age of 18
  • Patients unwilling to participate in the study, or unable to sign the bio-collection consent form

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: PXE cohort 2019-2020
PXE patient cohort monitored at referral centre from 2019 to 2020: fecal and blood samples
Diagnostic test: Fecal and blood samples
Fecal samples for intestinal microbiota analysis; Blood and fecal samples for assessment of various forms of vitamin K

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fecal samples for intestinal microbiota analysis
Time Frame: 15 min
Gut microbiota composition and relative abundance of species (via metagenomic sequencing)
15 min
Fecal samples for assessment of various forms of vitamin K
Time Frame: 15 min
Fecal Vitamin K species
15 min
Blood samples for assessment of various forms of vitamin K
Time Frame: 15 min
Plasma Vitamin K species
15 min
Blood samples for assessment of dp-ucMGP
Time Frame: 15 min
Plasma dp-ucMGP
15 min
Blood samples for assessment of PIVKA-II
Time Frame: 15 min
Serum PIVKA-II
15 min
Severity of ocular and cardiovascular PXE manifestations and extent of PXE skin changes
Time Frame: 15 min

Modified Phenodex score:

  • Skin lesions severity: S0=No sign; S1= Papules/bumps; S2= Plaques of coalesced papules; S3= Lax and redundant skin
  • Number of affected skin sites: for Typical and Nontypical areas
  • Ophthalmological involvement: E0= No sign; E1= Peau d'orange ; E2= Angioid streaks; E3a=Medical history of bleeding and/or scarring; E3b= Unilateral or bilateral blindness
  • Gastrointestinal bleeding: G0= No sign; G1= Gastrointestinal bleeding as related to PXE
  • Vascular involvement: V0= No sign; V1= Weak or absent pulse or peripheral artery disease revealed by vascular imaging; V2= Intermittent claudication; V3= Medical history of vascular surgery or Stroke/TIA
  • Cardiac involvement: C0= No sign; C1= medical history of chest pain/angina/abnormal EKG or abnormal stress test with no symptom, or Mitral insufficiency; C2= Heart attack
  • Renal involvement: R0= No sign; R1a= asymptomatic nephrocalcinosis revealed by imaging; R1b= Nephrolithiasis
15 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Collaborators

Maastricht University
Biofortis Mérieux NutriSciences

Investigators

  • Principal Investigator: Ludovic MARTIN, MD, PhD, Department of Dermatology, University Hospital of Angers

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2019

Primary Completion (Anticipated)

January 30, 2020

Study Completion (Anticipated)

January 30, 2020

Study Registration Dates

First Submitted

January 19, 2019

First Submitted That Met QC Criteria

January 19, 2019

First Posted (Actual)

January 23, 2019

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018/79

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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