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

Queen Mary University of London50 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Hypermobile Ehlers-Danlos Syndrome Irritable Bowel Syndrome Functional Gastrointestinal Disorders

Interventions

Dietician adviceBEHAVIORAL

Personalised dietetic advice

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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)

Locations (1)

Queen Marys University London

London, United Kingdom

Outcomes

Primary Outcomes

Number of patients

Number of patients who adhere to dietary recommendations based on acceptability of intervention and ease of delivery.

Time frame: 3 months

Secondary Outcomes

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)

Time frame: 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)

Time frame: 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)

Time frame: 3 months

Visceral Sensitivity Index (VSI)

15-item measurement of gastrointestinal-specific anxiety (min: 0 max: 75, higher score means worse gastrointestinal specific anxiety)

Time frame: 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)

Time frame: 3 months

Composite Autonomic Symptom Score (COMPASS-31)

Data from ClinicalTrials.gov

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