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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03813550
Other study ID # 2018/79
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 21, 2019
Est. completion date January 30, 2020

Study information

Verified date January 2019
Source University Hospital, Angers
Contact Ludovic MARTIN, MD, PhD
Phone +332.41.35.55.76
Email LuMartin@chu-angers.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France Department of Dermatology, University Hospital of Angers Angers Pays De Loire
France Biofortis Mérieux NutriSciences Saint-Herblain Pays De La Loire
Netherlands Department of Biochemistry, University Maastricht Maastricht

Sponsors (3)

Lead Sponsor Collaborator
University Hospital, Angers Biofortis Mérieux NutriSciences, Maastricht University

Countries where clinical trial is conducted

France,  Netherlands, 

References & Publications (39)

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Outcome

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