Prevalence of Mast Cell Activation Syndrome in Patients With Ehlers Danlos Hypermobile Syndrome With Digestive Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Prevalence of mast cell activation syndrome in patients with hypermobile Ehlers Danlos syndrome with digestive disorders
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Prevalence of mast cell activation syndrome in patients with hypermobile Ehlers Danlos syndrome with digestive disorders
时间窗: 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.
次要结局
- Frequency of the symptoms after treatment with anti-histamines(2 months)
- Medical Outcome Study Short-Form 36 (MOS SF-36 ) survey after antihistamine treatment(2 months)
- Frequency of consumption of analgesics(2 months)
- Frequency of intolerance according to particular food consumption(2 months)