Examining the link between Ehlers Danlos syndrome and mast cell activation in patients with digestive issues
Prevalence of Mast Cell Activation Syndrome in Patients With Ehlers Danlos Hypermobile Syndrome With Digestive Disorders
This study is trying to see if people with hypermobile Ehlers Danlos syndrome who have digestive issues also have mast cell activation syndrome.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | Lille Catholic University Academic / other |
| Locations | 1 site (Lille, Nord) |
| Trial ID | NCT05382169 on ClinicalTrials.gov |
What this trial studies
This observational study aims to confirm the association between hypermobile Ehlers Danlos syndrome (hEDS) and mast cell activation syndrome (MCAS) in patients experiencing digestive disorders. Participants will be assessed in allergology departments, focusing on those who are scheduled for evaluation of functional digestive pain. The study will involve determining the presence of mast cell activation syndrome among these patients. The findings could enhance understanding of the relationship between these conditions and improve patient management.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 14 and older with hypermobile Ehlers Danlos syndrome and digestive disorders who can participate in assessments.
Not a fit: Patients under guardianship or those who have recently taken high-dose antihistamines may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better diagnosis and treatment options for patients suffering from both hEDS and digestive disorders.
How similar studies have performed: While the association between hEDS and MCAS is being explored, this specific observational approach is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Lille, Nord
- Saint-Vincent-de-Paul hospital — Lille, Nord, France (Recruiting)
Study contacts
- Principal investigator: Juliette CARON, Md — Lille Catholic University
- Study coordinator: Marie DE SOLERE
- Email: drci@ghicl.net
- Phone: +33320225269
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.