Ehlers Danlos Hypermobile SyndromeSAMEDNCT05382169
Prevalence of Mast Cell Activation Syndrome in Patients With EDS With Digestive Disorders
An observational study of Ehlers Danlos Hypermobile Syndrome, run by Lille Catholic University at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Ehlers Danlos Hypermobile Syndrome
- What is being tested?
- Determine the presence of mast cell activation syndrome
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 28 Sep 2022to Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects with EDSh with digestive disorders
Who may be able to join
- 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
Who cannot join
- 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)
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Saint-Vincent-de-Paul hospital
Lille, Nord, 59020
Juliette CARON, Md, 07 70 18 45 64, caron.juliette@ghicl.net
About this study
Official title: Prevalence of Mast Cell Activation Syndrome in Patients With Ehlers Danlos Hypermobile Syndrome With Digestive Disorders
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.
- Conditions
- Ehlers Danlos Hypermobile Syndrome
- Being tested
- Determine the presence of mast cell activation syndrome
- Keywords
- Genetic disease, Collagen abnormality, Nausea, Heartburn, Ehlers Danlos hypermobile syndrome, Mast cell activation syndrome (MCAS), Allergology
- Medical subject headings
- Genetic Diseases, Inborn, Nausea, Heartburn, Mast Cell Activation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determine the presence of mast cell activation syndromeOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of mast cell activation syndrome in patients with hypermobile Ehlers Danlos syndrome with digestive disorders
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.
Measured: 2 months
Secondary outcomes (4)
Frequency of the symptoms after treatment with anti-histamines
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 .
Measured: 2 months
Medical Outcome Study Short-Form 36 (MOS SF-36 ) survey after antihistamine treatment
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
Measured: 2 months
Frequency of consumption of analgesics
The frequency of consumption of different analgesics will be studied over the two months preceding V1 and between V1 and V2.
Measured: 2 months
Frequency of intolerance according to particular food consumption
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start28 Sep 2022
- Primary completionJan 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ehlers Danlos Hypermobile SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juliette CARON, Md, Principal investigator, Lille Catholic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05382169
- Sponsor's protocol ID
- RC-P00115
- Acronym
- SAMED
- Status last verified
- Jan 2023
- First submitted
- 16 May 2022
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Mast Cell Activation Syndrome in Patients With Ehlers Danlos Hypermobile Syndrome With Digestive Disorders
- ClinicalTrials.gov ID
- NCT05382169
- Acronym / sponsor ID
- SAMED / RC-P00115
- Conditions
- Ehlers Danlos Hypermobile Syndrome
- Keywords
- Genetic disease, Collagen abnormality, Nausea, Heartburn, Ehlers Danlos hypermobile syndrome, Mast cell activation syndrome (MCAS), Allergology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects with EDSh with digestive disorders
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (18 listed)
- 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 :
- Patients deprived of liberty, pregnant or nursing women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Determine the presence of mast cell activation syndromeMast 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. | Other | – |
Primary outcome
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 : * 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.
4 secondary outcomes
Frequency of the symptoms after treatment with anti-histamines
Time frame: 2 months
Medical Outcome Study Short-Form 36 (MOS SF-36 ) survey after antihistamine treatment
Time frame: 2 months
Frequency of consumption of analgesics
Time frame: 2 months
Frequency of intolerance according to particular food consumption
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Ehlers Danlos Hypermobile Syndrome
Not yet recruitingObservational study
CLINICAL AND BIOLOGICAL DATABASE OF PATIENTS WITH NON-VASCULAR EHLERS-DANLOS SYNDROMES
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juliette CARON, Md principal investigator
Lille Catholic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ehlers Danlos Hypermobile Syndrome, run by Lille Catholic University at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie DE SOLERE (+33320225269, drci@ghicl.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of mast cell activation syndrome in patients with hypermobile Ehlers Danlos syndrome with digestive disorders (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023.