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

Primary Purpose

Hypermobile Ehlers-Danlos Syndrome, Irritable Bowel Syndrome, Functional Gastrointestinal Disorders

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Dietician advice
Sponsored by
Queen Mary University of London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hypermobile Ehlers-Danlos Syndrome focused on measuring Nutrition, Diet

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Queen Marys University London

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Community cohort

Clinic cohort

Arm Description

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

Participants from a Tertiary Neurogastroenterology clinic who have low die quality

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
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)
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)
Visceral Sensitivity Index (VSI)
15-item measurement of gastrointestinal-specific anxiety (min: 0 max: 75, higher score means worse gastrointestinal specific anxiety)
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)
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)
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))
Resource Use Questionnaire
16-item questionnaire to assess healthcare and health product utilisation over the preceding 3 months (no minimum / maximum, no score)

Full Information

First Posted
November 16, 2021
Last Updated
August 4, 2023
Sponsor
Queen Mary University of London
Collaborators
University College, London
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1. Study Identification

Unique Protocol Identification Number
NCT05148039
Brief Title
Comprehensive Assessment of Nutrition and Dietary Intervention in Hypermobile Ehlers Danlos Syndrome
Acronym
CANDI-hEDS2
Official Title
Comprehensive Assessment of Nutrition & Dietary Intervention in Hypermobile Ehlers Danlos Syndrome (hEDS/HSD): a Personalised Approach: Phase 2 & 3
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
April 7, 2022 (Actual)
Primary Completion Date
July 3, 2023 (Actual)
Study Completion Date
July 3, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Queen Mary University of London
Collaborators
University College, London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypermobile Ehlers-Danlos Syndrome, Irritable Bowel Syndrome, Functional Gastrointestinal Disorders
Keywords
Nutrition, Diet

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Tertiary clinic versus a selective community cohort
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Community cohort
Arm Type
Active Comparator
Arm Description
Participants from the Ehlers Danlos UK society community who low diet quality
Arm Title
Clinic cohort
Arm Type
Active Comparator
Arm Description
Participants from a Tertiary Neurogastroenterology clinic who have low die quality
Intervention Type
Behavioral
Intervention Name(s)
Dietician advice
Intervention Description
Personalised dietetic advice
Primary Outcome Measure Information:
Title
Number of patients
Description
Number of patients who adhere to dietary recommendations based on acceptability of intervention and ease of delivery.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
United Kingdom Diet Quality Index as calculated by the Scottish Collaborative Group Food Frequency Questionnaire (SCG FFQ)
Description
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
Title
Gastrointestinal Symptom Rating Scale (GSRS)
Description
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
Title
Hospital Anxiety and Depression Scale (HADS)
Description
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
Title
Visceral Sensitivity Index (VSI)
Description
15-item measurement of gastrointestinal-specific anxiety (min: 0 max: 75, higher score means worse gastrointestinal specific anxiety)
Time Frame
3 months
Title
Patient Health Questionnaire-15 (PHQ-15)
Description
15-item questionnaire to assess the domain of somatic symptoms (min: 0 max: 30, higher score means worse somatic symptoms)
Time Frame
3 months
Title
Composite Autonomic Symptom Score (COMPASS-31)
Description
31-item score to assess for symptoms of autonomic nervous system disturbance (min: 0 max 100, higher score means worse autonomic symptoms)
Time Frame
3 months
Title
Short Form 6D version 2 (SF-6Dv2)
Description
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))
Time Frame
3 months
Title
Resource Use Questionnaire
Description
16-item questionnaire to assess healthcare and health product utilisation over the preceding 3 months (no minimum / maximum, no score)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Queen Marys University London
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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