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

Not Applicable

Completed

• Conditions: Functional Gastrointestinal Disorders; Hypermobile Ehlers-Danlos Syndrome; Irritable Bowel Syndrome
• Interventions: Behavioral: Dietician advice

• Registration Number: NCT05148039
• Lead Sponsor: Queen Mary University of London

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-11-16
• Study First Submitted QC: 2021-11-30
• Study First Posted: 2021-12-08
• Study Start: 2022-04-07
• Primary Completion: 2023-07-03
• Study Completion: 2023-07-03
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-04
• Last Update Posted: 2023-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Community cohort	Dietician advice	Participants from the Ehlers Danlos UK society community who low diet quality
Clinic cohort	Dietician advice	Participants from a Tertiary Neurogastroenterology clinic who have low die quality

Primary Outcome Measures

Name	Time	Method
Number of patients	3 months	Number of patients who adhere to dietary recommendations based on acceptability of intervention and ease of delivery.

Secondary Outcome Measures

Name	Time	Method
Gastrointestinal Symptom Rating Scale (GSRS)	3 months	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)
Patient Health Questionnaire-15 (PHQ-15)	3 months	15-item questionnaire to assess the domain of somatic symptoms (min: 0 max: 30, higher score means worse somatic symptoms)
Visceral Sensitivity Index (VSI)	3 months	15-item measurement of gastrointestinal-specific anxiety (min: 0 max: 75, higher score means worse gastrointestinal specific anxiety)
Short Form 6D version 2 (SF-6Dv2)	3 months	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))
United Kingdom Diet Quality Index as calculated by the Scottish Collaborative Group Food Frequency Questionnaire (SCG FFQ)	3 months	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)
Composite Autonomic Symptom Score (COMPASS-31)	3 months	31-item score to assess for symptoms of autonomic nervous system disturbance (min: 0 max 100, higher score means worse autonomic symptoms)
Hospital Anxiety and Depression Scale (HADS)	3 months	14-item scale assessing symptoms of either anxiety or depression (min: 0 max: 21, higher score means worse anxiety or depression)
Resource Use Questionnaire	3 months	16-item questionnaire to assess healthcare and health product utilisation over the preceding 3 months (no minimum / maximum, no score)

Trial Locations

Locations (1)

Queen Marys University London; 🇬🇧 London, United Kingdom