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

Sponsor

Lille Catholic University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05382169

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Ehlers Danlos Hypermobile Syndrome	Other: Determine the presence of mast cell activation syndrome

Study Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prevalence of Mast Cell Activation Syndrome in Patients With Ehlers Danlos Hypermobile Syndrome With Digestive Disorders

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Mar 1, 2026

Outcome Measures

Primary Outcome Measures

Prevalence of mast cell activation syndrome in patients with hypermobile Ehlers Danlos syndrome with digestive disorders [2 months]
The presence of mast cell activation syndrome will be described in three modalities : confirmed, possible, and unlikely. Mast cell activation syndrome will be confirmed if the following three conditions are met : at least two clinical signs compatible with mast cell activation syndrome (MCAS) before the first consultation (V1) improvement of symptoms with 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 compatible with MCAS before the first consultation (V1) improvement of symptoms under antihistamine at 2 months of the introduction of the treatment no significant increase in tryptase during crisis In all other cases, mast cell activation syndrome is unlikely.

Secondary Outcome Measures

Frequency of the symptoms after treatment with anti-histamines [2 months]
Symptoms are those established by Valent et al, 2012. For each clinical sign the patient will rate the frequency of the symptom: more than once a day, once a day, 2 to 6 times a week, once or less a week, never, over the two months prior to visit 1 (V1), and between V1 and the 2-month follow-up visit .
Medical Outcome Study Short-Form 36 (MOS SF-36 ) survey after antihistamine treatment [2 months]
MOS SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability
Frequency of consumption of analgesics [2 months]
The frequency of consumption of different analgesics will be studied over the two months preceding V1 and between V1 and V2.
Frequency of intolerance according to particular food consumption [2 months]
For a given food, at V1 and V2, intolerance will be qualified by the presence of digestive disorders following the consumption of the food among : cow's milk, goat's milk, sheep's milk, fresh cheeses, cow's milk cheese or yogurt, goat's milk cheese or yogurt, sheep's milk cheese or yogurt, wheat/gluten, dry sausage, ham, turkey, chicken, pork, beef, raw egg, cooked egg, smoked fish, canned fish fresh fish, shellfish, mollusks, tomatoes, potatoes, spinach, peas, cabbage, lentils, beans, lemons, oranges, strawberries, raspberries, pineapple, mango, apple, pear, nectarine, peach, banana, kiwi, nuts, peanuts, spices, beers, wines, spirits, other.

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years and Older

Sexes Eligible for Study:

All

Accepts 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