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Prevalence of Mast Cell Activation Syndrome in Patients With EDS With Digestive Disorders (SAMED)

L

Lille Catholic University

Status

Enrolling

Conditions

Ehlers Danlos Hypermobile Syndrome

Treatments

Other: Determine the presence of mast cell activation syndrome

Study type

Observational

Funder types

Other

Identifiers

NCT05382169
RC-P00115

Details and patient eligibility

About

The aim of the study is to confirm the association between hypermobile Ehlers Danlos syndrome (hEDS) and mast cell activation syndrome (MCAS) in patients with digestive disorders managed in allergology departments.

Enrollment

30 estimated patients

Sex

All

Ages

14+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • with hypermobile Ehlers Danlos syndrome
  • with digestive disorders
  • 14 years of age or older (minimum age for the MOS-SF 36 questionnaire)
  • able to answer the questionnaires
  • whose participation in a day hospital at Saint Vincent de Paul dedicated to the assessment of "functional digestive pain" is planned
  • who do not object to the use of their health data for research purposes

Additional criteria for minors :

  • No objection to the use of health data for research purposes by parents/guardians

Exclusion criteria

  • under guardianship or curatorship

  • having taken a long-term high-dose antihistamine treatment (H1 or H2) during the last two months, according to the following thresholds :

    • Desloratadine (>5 mg/jour)
    • Bilastine (>20 mg/jour)
    • Cetirizine (>20 mg/jour)
    • Ebastine (>10 mg/jour)
    • Fexofenadine (>150 mg/jour)
    • Levocetirizine (>5 mg/jour)
    • Loratadine (>10 mg/jour)
    • Exocetiridine (5 mg/jour)
    • Mizolastine (>10 mg/jour)
    • Rupatadine (>10 mg/jour)
    • Polaramine (>10 mg/jour)
    • Oxomemazine (>2 mg/jour)
    • Hydroxyzine (>25 mg/jour)
    • Doxylamine (>15 mg/jour)
    • Cimetidine (>200 mg/jour)
  • Patients deprived of liberty, pregnant or nursing women

Trial contacts and locations

1

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Central trial contact

Marie DE SOLERE; William's VAN DEN BERGHE, CRA

Data sourced from clinicaltrials.gov

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