- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05382169
Prevalence of Mast Cell Activation Syndrome in Patients With EDS With Digestive Disorders (SAMED)
Prevalence of Mast Cell Activation Syndrome in Patients With Ehlers Danlos Hypermobile Syndrome With Digestive Disorders
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Marie DE SOLERE
- Phone Number: +33320225269
- Email: drci@ghicl.net
Study Contact Backup
- Name: William's VAN DEN BERGHE, CRA
- Phone Number: +33320225731
- Email: VanDenBerghe.Williams@ghicl.net
Study Locations
-
-
Nord
-
Lille, Nord, France, 59020
- Recruiting
- Saint-Vincent-de-Paul hospital
-
Contact:
- Juliette CARON, Md
- Phone Number: 07 70 18 45 64
- Email: caron.juliette@ghicl.net
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of mast cell activation syndrome in patients with hypermobile Ehlers Danlos syndrome with digestive disorders
Time Frame: 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 :
Mast cell activation syndrome will be possible if:
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of the symptoms after treatment with anti-histamines
Time Frame: 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 .
|
2 months
|
Medical Outcome Study Short-Form 36 (MOS SF-36 ) survey after antihistamine treatment
Time Frame: 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
|
2 months
|
Frequency of consumption of analgesics
Time Frame: 2 months
|
The frequency of consumption of different analgesics will be studied over the two months preceding V1 and between V1 and V2.
|
2 months
|
Frequency of intolerance according to particular food consumption
Time Frame: 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.
|
2 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Juliette CARON, Md, Lille Catholic University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC-P00115
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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