Functional Gastrointestinal Disorders, Hypermobile Ehlers-Danlos Syndrome, Irritable Bowel Syndrome
Conditions
Keywords
Nutrition, Diet
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.
Interventions
BEHAVIORALDietician advice
Personalised dietetic advice
Sponsors
University College, London
Queen Mary University of London
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Tertiary clinic versus a selective community cohort
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients | 3 months | Number of patients who adhere to dietary recommendations based on acceptability of intervention and ease of delivery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal Symptom Rating Scale (GSRS) | 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) |
| Hospital Anxiety and Depression Scale (HADS) | 3 months | 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) | 3 months | 15-item measurement of gastrointestinal-specific anxiety (min: 0 max: 75, higher score means worse gastrointestinal specific anxiety) |
| United Kingdom Diet Quality Index as calculated by the Scottish Collaborative Group Food Frequency Questionnaire (SCG FFQ) | 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) |
| Composite Autonomic Symptom Score (COMPASS-31) | 3 months | 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) | 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)) |
| Resource Use Questionnaire | 3 months | 16-item questionnaire to assess healthcare and health product utilisation over the preceding 3 months (no minimum / maximum, no score) |
| Patient Health Questionnaire-15 (PHQ-15) | 3 months | 15-item questionnaire to assess the domain of somatic symptoms (min: 0 max: 30, higher score means worse somatic symptoms) |
Countries
United Kingdom
Outcome results
None listed