Comprehensive Assessment of Nutrition and Dietary Intervention in Hypermobile Ehlers Danlos Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comprehensive Assessment of Nutrition & Dietary Intervention in Hypermobile Ehlers Danlos Syndrome (hEDS/HSD): a Personalised Approach: Phase 2 & 3

Conditions
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Hypermobile Ehlers-Danlos Syndrome, Irritable Bowel Syndrome, Functional Gastrointestinal Disorders

Intervention / Treatment
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* Behavioral: Dietician advice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Tertiary clinic versus a selective community cohort
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Community cohort<br>Participants from the Ehlers Danlos UK society community who low diet quality | Behavioral: Dietician advice<br>* Personalised dietetic advice<br>|
| Active Comparator: Clinic cohort<br>Participants from a Tertiary Neurogastroenterology clinic who have low die quality | Behavioral: Dietician advice<br>* Personalised dietetic advice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients | Number of patients who adhere to dietary recommendations based on acceptability of intervention and ease of delivery. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| United Kingdom Diet Quality Index as calculated by the Scottish Collaborative Group Food Frequency Questionnaire (SCG FFQ) | 170- item semi-quantitative questionnaire, designed to assess the habitual diet of medium to large sized populations during the previous 3 months (higher score means better diet quality) | 3 months | 
| Gastrointestinal Symptom Rating Scale (GSRS) | 13-item questionnaire assessing gastrointestinal symptoms across five domains (pain, bloating, constipation, diarrhoea and satiety) over a period of one week. (min:0 max: 7, higher score means worse symptoms) | 3 months | 
| Hospital Anxiety and Depression Scale (HADS) | 14-item scale assessing symptoms of either anxiety or depression (min: 0 max: 21, higher score means worse anxiety or depression) | 3 months | 
| Visceral Sensitivity Index (VSI) | 15-item measurement of gastrointestinal-specific anxiety (min: 0 max: 75, higher score means worse gastrointestinal specific anxiety) | 3 months | 
| Patient Health Questionnaire-15 (PHQ-15) | 15-item questionnaire to assess the domain of somatic symptoms (min: 0 max: 30, higher score means worse somatic symptoms) | 3 months | 
| Composite Autonomic Symptom Score (COMPASS-31) | 31-item score to assess for symptoms of autonomic nervous system disturbance (min: 0 max 100, higher score means worse autonomic symptoms) | 3 months | 
| Short Form 6D version 2 (SF-6Dv2) | 6-item questionnaire to assess impact of physical symptoms on daily functioning and quality of life (ranges from 1 (full health) to -0.574 (worst health); 0 (death)) | 3 months | 
| Resource Use Questionnaire | 16-item questionnaire to assess healthcare and health product utilisation over the preceding 3 months (no minimum / maximum, no score) | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutrition, Diet