Hypermobile Ehlers-Danlos SyndromeCANDI-hEDS2NCT05148039
Comprehensive Assessment of Nutrition and Dietary Intervention in Hypermobile Ehlers Danlos Syndrome
A study testing Dietician advice in people with Hypermobile Ehlers-Danlos Syndrome and Irritable Bowel Syndrome, run by Queen Mary University of London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hypermobile Ehlers-Danlos Syndrome, Irritable Bowel Syndrome, Functional Gastrointestinal Disorders
- What is being tested?
- Dietician advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Apr 2022to 3 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypermobile Ehlers-Danlos Syndrome, Irritable Bowel Syndrome, Functional Gastrointestinal Disorders
- Being tested
- Dietician advice
- Keywords
- Nutrition, Diet
- Medical subject headings
- Ehlers-Danlos syndrome type 3, Irritable Bowel Syndrome, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietician adviceBehavioural
Personalised dietetic advice
| Study group | Role | What they receive |
|---|---|---|
| Community cohort | Active comparator | Participants from the Ehlers Danlos UK society community who low diet quality Receives: Behavioral: Dietician advice |
| Clinic cohort | Active comparator | Participants from a Tertiary Neurogastroenterology clinic who have low die quality Receives: Behavioral: Dietician advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients
Number of patients who adhere to dietary recommendations based on acceptability of intervention and ease of delivery.
Measured: 3 months
Secondary outcomes (8)
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)
Measured: 3 months
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)
Measured: 3 months
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)
Measured: 3 months
Visceral Sensitivity Index (VSI)
15-item measurement of gastrointestinal-specific anxiety (min: 0 max: 75, higher score means worse gastrointestinal specific anxiety)
Measured: 3 months
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)
Measured: 3 months
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)
Measured: 3 months
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))
Measured: 3 months
Resource Use Questionnaire
16-item questionnaire to assess healthcare and health product utilisation over the preceding 3 months (no minimum / maximum, no score)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start7 Apr 2022
- Primary completion3 Jul 2023
- Study completion3 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypermobile Ehlers-Danlos SyndromeStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Tertiary clinic versus a selective community cohort
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- University College, London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05148039
- Sponsor's protocol ID
- 306930
- Acronym
- CANDI-hEDS2
- Status last verified
- Aug 2023
- First submitted
- 16 Nov 2021
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Assessment of Nutrition & Dietary Intervention in Hypermobile Ehlers Danlos Syndrome (hEDS/HSD): a Personalised Approach: Phase 2 & 3
- ClinicalTrials.gov ID
- NCT05148039
- Acronym / sponsor ID
- CANDI-hEDS2 / 306930
- Conditions
- Hypermobile Ehlers-Danlos Syndrome, Irritable Bowel Syndrome, Functional Gastrointestinal Disorders
- Keywords
- Nutrition, Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- University College, London
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- 3 Jul 2023 (actual)
- Study completion
- 3 Jul 2023 (actual)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Tertiary clinic versus a selective community cohort
| Arm | Type | Receives |
|---|---|---|
| Community cohort | Active comparator | Behavioral: Dietician adviceParticipants from the Ehlers Danlos UK society community who low diet quality |
| Clinic cohort | Active comparator | Behavioral: Dietician adviceParticipants from a Tertiary Neurogastroenterology clinic who have low die quality |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietician advicePersonalised dietetic advice | Behavioural | Clinic cohort, Community cohort |
Primary outcome
Number of patients
Time frame: 3 months
Number of patients who adhere to dietary recommendations based on acceptability of intervention and ease of delivery.
8 secondary outcomes
United Kingdom Diet Quality Index as calculated by the Scottish Collaborative Group Food Frequency Questionnaire (SCG FFQ)
Time frame: 3 months
Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: 3 months
Hospital Anxiety and Depression Scale (HADS)
Time frame: 3 months
Visceral Sensitivity Index (VSI)
Time frame: 3 months
Patient Health Questionnaire-15 (PHQ-15)
Time frame: 3 months
Composite Autonomic Symptom Score (COMPASS-31)
Time frame: 3 months
Short Form 6D version 2 (SF-6Dv2)
Time frame: 3 months
Resource Use Questionnaire
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietician advice in people with Hypermobile Ehlers-Danlos Syndrome and Irritable Bowel Syndrome, run by Queen Mary University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2023.