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

August 4, 2023 updated by: Queen Mary University of London

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Community cohort
Participants from the Ehlers Danlos UK society community who low diet quality
Behavioral: Dietician advice
Personalised dietetic advice
Active Comparator: Clinic cohort
Participants from a Tertiary Neurogastroenterology clinic who have low die quality
Behavioral: Dietician advice
Personalised dietetic advice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients
Time Frame: 3 months
Number of patients who adhere to dietary recommendations based on acceptability of intervention and ease of delivery.
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Mary University of London

Collaborators

University College, London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2022

Primary Completion (Actual)

July 3, 2023

Study Completion (Actual)

July 3, 2023

Study Registration Dates

First Submitted

November 16, 2021

First Submitted That Met QC Criteria

November 30, 2021

First Posted (Actual)

December 8, 2021

Study Record Updates

Last Update Posted (Actual)

August 7, 2023

Last Update Submitted That Met QC Criteria

August 4, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 306930

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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