Study into Crohn's Disease Treatment Efficacy
Research type
Research Study
Full title
Investigation into the Interaction Between the Microbiome, Malnutrition, Genetics and Crohn’s Disease Treatment Efficacy
IRAS ID
277231
Contact name
Andrew Smith
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2020/04/128, UCL Data Protection Number
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
Crohn’s disease (CD) is a chronic, relapsing inflammatory bowel disease that frequently presents segments of diseased and normal bowel. According to NICE, there are at least 115,000 people in the UK with CD; and, the prevalence and incidence of CD are increasing. There is currently no cure for CD, therefore treatment focuses on inducing and maintaining disease remission by controlling inflammatory response and managing the effects of that inflammatory response.
Malnutrition is prevalent in 65%-75% of Crohn’s disease (CD) patients; and, current research has found it to have a direct, negative impact on the course of the disease: by heightening inflammatory state and increasing the likelihood of both post-operative complication and non-responsiveness to biologic therapy. Whilst research has found an association between malnutrition and CD treatments, the mechanism and extent of those interactions remain unclear.
Recent research has linked dysbiosis of the intestinal microbiome, and its associated metabolic functions, with the pathophysiology of CD in genetically susceptible individuals. Several studies have found that genetic risk and microbiome dysbiosis in IBD patients are associated with a reduction in the efficacy of anti-TNF agents, and an increased risk of post-operative recurrence. However, research into the effects of the intestinal microbiome and genetic risk on human physiology is still very much in its infancy, and a long way from establishing aetiology.
This research aims to identify microbial, genetic and nutritional markers for the efficacy of biologic therapy and gastrointestinal surgery. It will also seek to break new ground by examining a possible association between malnutrition, genetics, the microbiome and treatment efficacy for non-anti-TNF biologic agents, such as the new CD biologic, ustekinumab.
REC name
HSC REC B
REC reference
20/NI/0106
Date of REC Opinion
4 Aug 2020
REC opinion
Further Information Favourable Opinion