Prevalence of Mast Cell Activation Syndrome in Patients With EDS With Digestive Disorders
NCT ID: NCT05382169
Last Updated: 2023-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
30 participants
OBSERVATIONAL
2022-09-28
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Determine the presence of mast cell activation syndrome
Mast cell activation syndrome will be confirmed if the following three conditions are met (according to Valent et al, 2012) :
* At least two clinical signs compatible with MAS before the first consultation (V1)
* Improvement of symptoms on antihistamines within 2 months of initiation of treatment
* Significant increase in tryptase during crisis
Mast cell activation syndrome will be possible if :
* At least two clinical signs consistent with MAS before the first consultation (V1)
* Improvement of symptoms with antihistamines within 2 months of initiation of treatment
* No significant increase in tryptase during crisis In all other cases, mast cell activation syndrome is unlikely.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
14 Years
ALL
No
Sponsors
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Lille Catholic University
OTHER
Responsible Party
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Principal Investigators
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Juliette CARON, Md
Role: PRINCIPAL_INVESTIGATOR
Lille Catholic University
Locations
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Saint-Vincent-de-Paul hospital
Lille, Nord, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RC-P00115
Identifier Type: -
Identifier Source: org_study_id
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