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

Irritable Bowel Syndrome Clinical Trial

— CANDI-hEDS2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05148039
• Other study ID #: 306930
• Status: Completed
• Phase: N/A
• Start date: April 7, 2022
• Est. completion date: July 3, 2023

Study information

• Verified date: August 2023
• Source: Queen Mary University of London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 3, 2023
• Est. primary completion date: July 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Digestive System Diseases
• Ehlers-Danlos Syndrome
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases
• Hypermobile Ehlers-Danlos Syndrome
• Irritable Bowel Syndrome
• Syndrome

Intervention

Behavioral:
• Dietician advice
Personalised dietetic advice

Locations

Country	Name	City	State
United Kingdom	Queen Marys University London	London

Sponsors (2)

Lead Sponsor	Collaborator
Queen Mary University of London	University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients	Number of patients who adhere to dietary recommendations based on acceptability of intervention and ease of delivery.	3 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Visceral Sensitivity Index (VSI)	15-item measurement of gastrointestinal-specific anxiety (min: 0 max: 75, higher score means worse gastrointestinal specific anxiety)	3 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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