Biologics and Partial Enteral Nutrition Study

• Research type

  Research Study

• Full title

  Combining partial enteral nutrition with biologics to optimise induction and maintenance therapy for adults with active ileocolonic Crohn's Disease

• IRAS ID

  292648

• Contact name

  Bernadette White

• Contact email

  b.white.1@research.gla.ac.uk

• Sponsor organisation

  NHS Glasgow and Clyde

• Clinicaltrials.gov Identifier

  NCT04859088

• Duration of Study in the UK

  5 years, 0 months, 1 days

• Research summary

  Crohn’s disease (CD) is a chronic, incurable condition associated with inflammation in the gut lining. It causes diarrhoea, severe abdominal pain, poor nutrition and adversely affects the quality of life of sufferers. Two of the best treatments currently used in people with Crohn’s disease are special drug injections (biologics), and a liquid-only diet using specialised milkshakes. However, treatment with biologics is only successful in approximately 40% of the patients, and although treatment with the liquid-only diet has a better safety and effectiveness profile it is difficult for patients to stick to this as their sole source of nutrition for 6-8 weeks, particularly for adults. In the BIOPIC study, we want to investigate whether replacing half of a habitual diet with specialised milkshakes will improve response to standard treatment with biologics in adults with CD.
  To achieve this, we will recruit 80 adult patients with active CD who are due to start biologics injections therapy as part of their standard of care for the first time. We will also recruit 80 healthy volunteers who will match CD patients through age, sex, and BMI to act as a benchmark of healthy gut bacteria composition. CD patients will be randomly allocated to replace either half of their normal diet with milkshakes or to follow their usual diet for 6 weeks. We will compare the proportion of patients whose symptoms and disease markers, in collected blood and in faeces, will improve between the two groups at 6 and 12 weeks, and how many of them will remain symptoms-free up to a year following treatment. We will also explore whether the half-liquid diet will influence patients’ nutrition and their quality of life. Last, we will investigate if gut bacteria changes and their metabolites associate with patients' eating habits and their responses to treatment with biologics.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  21/SC/0210

• Date of REC Opinion

  10 Aug 2021

• REC opinion

  Further Information Favourable Opinion