INDUCT

  • Research type

    Research Study

  • Full title

    Diet in Addition to Standard of Care for Induction of Remission in Mild to Moderate Active Paediatric Ulcerative colitis: A Single Blinded, International Randomised Controlled Trial

  • IRAS ID

    277933

  • Contact name

    Nick Croft

  • Contact email

    n.m.croft@qmul.ac.uk

  • Sponsor organisation

    Queen Mary University of London

  • Clinicaltrials.gov Identifier

    NCT03980405

  • Duration of Study in the UK

    2 years, 0 months, 1 days

  • Research summary

    Ulcerative colitis (UC) is a chronic disease that causes inflammation in the colon. The exact reason that some people have UC is unknown. Researchers believe that the immune system in UC is overactive and that environmental factors, such as gut bacteria, contribute to inflammation. Gut bacteria (or microbiome) of UC patients is different from healthy people’s. Research has shown that certain factors in our diet change the way the intestines work and could be related to disease. Normally, bowel wall acts as a barrier allowing nutrients into the body and keeping harmful substances and bacteria away. Certain foods have been shown to make bowel ‘leaky’, which allows unwanted substances to pass through and increases inflammation. Researchers believe that eliminating these foods will improve gut health and response to therapy in UC. Dietary treatment has been shown effective in a different chronic inflammatory intestinal disease - Crohn's disease (CD). Researchers developed a diet for CD, which removed certain foods thought to increase gut inflammation. After 12 weeks, the diet helped 70% of children who tried it. In this study we want to see whether a similar approach will work in UC. All participants will already be receiving a stable standard of care treatment such as 5ASA or thiopurines. We will compare participants who receive standard dietary recommendations and those who follow a special UC diet (UCD). We hope to learn whether UCD improves response to standard of care therapy in children with UC and how it affects their microbiome. This might introduce a therapy option that does not involve strong medications and avoids possible medicine side effects.

  • REC name

    HSC REC A

  • REC reference

    20/NI/0115

  • Date of REC Opinion

    2 Oct 2020

  • REC opinion

    Further Information Favourable Opinion