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

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

Sponsors

Lead Sponsor: University Hospital, Angers

Collaborator: Maastricht University
Biofortis Mérieux NutriSciences

Source University Hospital, Angers
Brief Summary

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).

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.

Overall Status Unknown status
Start Date 2019-01-21
Completion Date 2020-01-30
Primary Completion Date 2020-01-30
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Fecal samples for intestinal microbiota analysis 15 min
Fecal samples for assessment of various forms of vitamin K 15 min
Blood samples for assessment of various forms of vitamin K 15 min
Blood samples for assessment of dp-ucMGP 15 min
Blood samples for assessment of PIVKA-II 15 min
Severity of ocular and cardiovascular PXE manifestations and extent of PXE skin changes 15 min
Enrollment 20
Condition
Intervention

Intervention Type: Diagnostic Test

Intervention Name: Fecal and blood samples

Description: Fecal samples for intestinal microbiota analysis; Blood and fecal samples for assessment of various forms of vitamin K

Arm Group Label: PXE cohort 2019-2020

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Ludovic MARTIN, MD, PhD Principal Investigator Department of Dermatology, University Hospital of Angers
Overall Contact

Last Name: Ludovic MARTIN, MD, PhD

Phone: +332.41.35.55.76

Email: [email protected]

Location
Facility: Status:
Biofortis Mérieux NutriSciences | Saint-Herblain, Pays De La Loire, 44800, France Active, not recruiting
Department of Dermatology, University Hospital of Angers | Angers, Pays De Loire, 49933, France Recruiting Ludovic Martin, MD, PhD +332.41.35.55.76 [email protected]
Department of Biochemistry, University Maastricht | Maastricht, 6229, Netherlands Active, not recruiting
Location Countries

France

Netherlands

Verification Date

2019-01-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: PXE cohort 2019-2020

Type: Other

Description: PXE patient cohort monitored at referral centre from 2019 to 2020: fecal and blood samples

Acronym IMPROVE
Patient Data Undecided
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Basic Science

Masking: None (Open Label)

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