Comprehensive Assessment of Nutrition & Dietary Intervention in Hypermobile Ehlers Danlos Syndrome (hEDS/HSD): a Personalised Approach: Phase 2 & 3
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of patients
研究概览
简要总结
This study involves a comprehensive nutritional assessment of hEDS participants who have functional gastrointestinal disorders and dietary intervention to broaden their food choices and nutritional intake.
详细描述
The impact of diet on symptoms in patients with Hypermobile Ehlers Danlos Syndrome (hEDS/HSD) is widely recognised yet poorly understood. The investigators aim is to assess existing dietary patterns and nutritional status in hEDS/HSD as well as pilot a personalised dietary strategy to optimise nutrition. Participants recruited from EDS UK and a tertiary Neurogastroenterology clinic at the Royal London Hospital will undergo comprehensive nutritional assessment and blood tests. The investigators will then undertake a feasibility study of personalised dietary intervention in select cohort of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have completed Phase I of the CANDI-hEDS study
- •Diagnosis of hEDS / HSD according to physical examination and history taking
- •Diagnosis of Functional Dyspepsia and / or Irritable Bowel Syndrome according to Rome IV criteria
- •Able and willing to give informed consent
- •Access to video conferencing and a smart phone device
- •Able to travel to the Wingate Institute
排除标准
- •Dependent upon artificial feeding (parenteral and enteral)
- •Structural gastrointestinal disease
- •Any chronic health condition which already requires a restricted diet e.g. diabetes mellitus
- •Functional vomiting disorder with associated weight loss
- •Multiple Type I hypersensitivity reactions to food groups (i.e. anaphylaxis, urticaria, respiratory symptoms or positive RAST tests).
- •Previous or current severe mental health disorder (e.g. severe depression with suicidal ideation)
- •Previous or current eating disorder
- •Positive screen for avoidant restrictive food intake disorder (ARFID)
结局指标
主要结局
Number of patients
时间窗: 3 months
Number of patients who adhere to dietary recommendations based on acceptability of intervention and ease of delivery.
次要结局
- Gastrointestinal Symptom Rating Scale (GSRS)(3 months)
- Patient Health Questionnaire-15 (PHQ-15)(3 months)
- Visceral Sensitivity Index (VSI)(3 months)
- Short Form 6D version 2 (SF-6Dv2)(3 months)
- United Kingdom Diet Quality Index as calculated by the Scottish Collaborative Group Food Frequency Questionnaire (SCG FFQ)(3 months)
- Composite Autonomic Symptom Score (COMPASS-31)(3 months)
- Hospital Anxiety and Depression Scale (HADS)(3 months)
- Resource Use Questionnaire(3 months)