Comprehensive Assessment of Nutrition and Dietary Intervention in Hypermobile Ehlers Danlos Syndrome (CANDI-hEDS2)

Queen Mary University of London

Status: Completed

Conditions: Irritable Bowel Syndrome; Functional Gastrointestinal Disorders; Hypermobile Ehlers-Danlos Syndrome

Treatments: Behavioral: Dietician advice

Study type: Interventional

Funder types: Other

Identifiers

NCT05148039

306930

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Community cohort

Active Comparator group

Description:

Participants from the Ehlers Danlos UK society community who low diet quality

Treatment:

Behavioral: Dietician advice

Clinic cohort

Active Comparator group

Description:

Participants from a Tertiary Neurogastroenterology clinic who have low die quality

Treatment:

Behavioral: Dietician advice