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

NCT ID: NCT05148039

Last Updated: 2023-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-07

Study Completion Date

2023-07-03

Brief Summary

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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

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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.

Conditions

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Hypermobile Ehlers-Danlos Syndrome Irritable Bowel Syndrome Functional Gastrointestinal Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Tertiary clinic versus a selective community cohort
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Community cohort

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

Group Type ACTIVE_COMPARATOR

Dietician advice

Intervention Type BEHAVIORAL

Personalised dietetic advice

Clinic cohort

Participants from a Tertiary Neurogastroenterology clinic who have low die quality

Group Type ACTIVE_COMPARATOR

Dietician advice

Intervention Type BEHAVIORAL

Personalised dietetic advice

Interventions

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Dietician advice

Personalised dietetic advice

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University College, London

OTHER

Sponsor Role collaborator

Queen Mary University of London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Queen Marys University London

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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306930

Identifier Type: -

Identifier Source: org_study_id

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