CANDI-hEDS 2

  • Research type

    Research Study

  • Full title

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

  • IRAS ID

    306930

  • Contact name

    Qasim Aziz

  • Contact email

    q.aziz@qmul.ac.uk

  • Sponsor organisation

    Queen Marys University of London (Queen Mary)

  • Clinicaltrials.gov Identifier

    NCT05148039

  • Duration of Study in the UK

    1 years, 6 months, 28 days

  • Research summary

    Summary of Research
    This study is being conducted to assess the impact of restrictive eating on nutritional status in patients who suffer from hypermobile ehlers danlos syndrome (hEDS). We will then determine if it is feasible to administer personalised dietary therapy to a cohort of patients who have both restrictive eating and poor nutritional status, to broaden their dietary food intake. We will assess for improvement in their functional gastrointestinal symptoms, other symptoms and general wellbeing. This study will lead to a better understanding of the nutritional issues faced by patients with hEDS/HSD and may lead to better ways of managing their diet.

    Summary of Results
    : we recruited 50 patients who fulfilled exclusion/inclusion criteria for this part of the study. We confirmed the diagnosis of hEDS using the 2017 criteria including physical examination. We then collected anthroprometric data and blood tests to assess for nutritional deficiencies. All patients completed a 5 day diet diary using Nutritics software. Their diet diary was then used to assess where their nutritional deficiencies may be and our dietician provided initial dietary advice via telephone consultation. They all received one follow up phone call to check compliance and ask questions. The data is currently being analysed. Delay in analysis occurred due to maternity leave of the research fellow.

    Summary of Findings
    we recruited 50 patients who fulfilled exclusion/inclusion criteria for this part of the study. We confirmed the diagnosis of hEDS using the 2017 criteria including physical examination. We then collected anthroprometric data and blood tests to assess for nutritional deficiencies. All patients completed a 5 day diet diary using Nutritics software. Their diet diary was then used to assess where their nutritional deficiencies may be and our dietician provided initial dietary advice via telephone consultation. They all received one follow up phone call to check compliance and ask questions. The data is currently being analysed. Delay in analysis occured due to maternity leave of the research fellow.

  • REC name

    Wales REC 6

  • REC reference

    22/WA/0019

  • Date of REC Opinion

    31 Jan 2022

  • REC opinion

    Further Information Favourable Opinion