Irritable Bowel Syndrome Clinical Trial
— CANDI-hEDS2Official title:
Comprehensive Assessment of Nutrition & Dietary Intervention in Hypermobile Ehlers Danlos Syndrome (hEDS/HSD): a Personalised Approach: Phase 2 & 3
NCT number | NCT05148039 |
Other study ID # | 306930 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 7, 2022 |
Est. completion date | July 3, 2023 |
Verified date | August 2023 |
Source | Queen Mary University of London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Queen Marys University London | London |
Lead Sponsor | Collaborator |
---|---|
Queen Mary University of London | University College, London |
United Kingdom,
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 |
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