Microbiome Manipulation in Patients with NAFLD and fibrosis

  • Research type

    Research Study

  • Full title

    Investigating the impact of faecal microbiota transplant on the clinical phenome of patients with non-alcoholic fatty liver disease and fibrosis

  • IRAS ID

    296522

  • Contact name

    Pinelopi Manousou

  • Contact email

    pinelopi.manousou@nhs.net

  • Sponsor organisation

    Imperial College London

  • Clinicaltrials.gov Identifier

    NCT06024681

  • Duration of Study in the UK

    2 years, 9 months, 4 days

  • Research summary

    We understand well that certain bacteria can cause us harm by causing infections when they enter the human gut. However, what doctors and scientists have realised only more recently is that there are also billions of ‘beneficial’ bacteria and other microbes living in the gut at any one time. These microbes do not cause us harm, and actually perform many roles in helping to keep us healthy, including through the production of chemicals that cross from the gut into our bloodstream where they may influence our weight and metabolism. We now also realise that patients with many different medical conditions have distinctive changes in the ‘balance’ of these bacteria within the gut, and this may impact upon how such diseases develop and progress. One such condition is non-alcoholic fatty liver disease (NAFLD), which is a disease characterised by abnormalities in metabolism. Patients with the form of the condition associated with liver scarring (fibrosis) appear to have the greatest ‘imbalance’ in gut bacteria.

    We are interested in seeing if we can restore the normal balance of gut bacteria in people with NAFLD and fibrosis, and particularly in measuring if this is associated with changes in the chemicals produced by these bacteria that affect metabolism. If these bacteria and chemicals do change, we wish to know to what degree they change and how long they stay changed for. To alter the gut bacteria, we will use a method called ‘faecal microbiota transplant (FMT)’. FMT involves taking stool (poo samples) from healthy screened donors, processing this in the laboratory to keep the desired microbes (but removing the unwanted waste material), and administering this into the gut of affected patients. We already know that FMT is a very effective treatment for particular patients with a form of gut infection called Clostridioides difficile infection.

  • REC name

    London - Harrow Research Ethics Committee

  • REC reference

    21/LO/0454

  • Date of REC Opinion

    22 Jul 2021

  • REC opinion

    Further Information Favourable Opinion