Clinical trial NCT05148039: Comprehensive Assessment of Nutrition and Dietary Intervention in Hypermobile Ehlers Danlos Syndrome
Official title: Comprehensive Assessment of Nutrition & Dietary Intervention in Hypermobile Ehlers Danlos Syndrome (hEDS/HSD): a Personalised Approach: Phase 2 & 3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypermobile Ehlers-Danlos Syndrome
Irritable Bowel Syndrome
Functional Gastrointestinal Disorders
Keywords: Nutrition
Diet
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
Collaborators: name: University College, London
First posted: 2021-12-08
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Tertiary clinic versus a selective community cohort
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of patients
timeFrame: 3 months
Secondary outcomes:
measure: United Kingdom Diet Quality Index as calculated by the Scottish Collaborative Group Food Frequency Questionnaire (SCG FFQ)
timeFrame: 3 months
measure: Gastrointestinal Symptom Rating Scale (GSRS)
timeFrame: 3 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 3 months
measure: Visceral Sensitivity Index (VSI)
timeFrame: 3 months
measure: Patient Health Questionnaire-15 (PHQ-15)
timeFrame: 3 months
measure: Composite Autonomic Symptom Score (COMPASS-31)
timeFrame: 3 months
measure: Short Form 6D version 2 (SF-6Dv2)
timeFrame: 3 months
measure: Resource Use Questionnaire
timeFrame: 3 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Queen Marys University London
Study officials:
References: