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

NCT ID: NCT05382169

Last Updated: 2023-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-28

Study Completion Date

2026-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ehlers Danlos Hypermobile Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Lille Catholic University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Juliette CARON, Md

Role: PRINCIPAL_INVESTIGATOR

Lille Catholic University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Saint-Vincent-de-Paul hospital

Lille, Nord, France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Marie DE SOLERE

Role: CONTACT

+33320225269

William's VAN DEN BERGHE, CRA

Role: CONTACT

+33320225731

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Juliette CARON, Md

Role: primary

07 70 18 45 64

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RC-P00115

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Microbiota and Allergy
NCT04750980 COMPLETED