A pilot RCT of patients with mild-moderate ulcerative colitis starting basic treatment with 5ASA to either a 12-week low food additive diet or standard care

This project is for PhD students only

BACKGROUND

Inflammatory Bowel Disease (IBD) is a chronic immune-mediated disorder which consists of two main forms; Crohn’s disease (CD) and ulcerative colitis (UC). It is a global disease, with an accelerating incidence in newly industrialised countries whose societies have become more westernised. Commonly, mesalazine drugs are positioned as first line treatment for patients with mild-moderate UC, however, only approximately 40%–70% achieve symptomatic response. Specialised dieticians are key members of an integrated approach to modern IBD management, delivering dietary therapies that can reduce symptoms and inflammation.  An ultra-processed dietary pattern (UPD) has been shown to correlate with higher circulating inflammatory cytokines and markers of oxidative stress.  Characteristic of an UPD is the regular consumption of food additives such as artificial sweeteners, emulsifiers and carrageenan gum. In previous work our team have developed a low food additive diet (LFAD) and demonstrated a reduction in food additives was correlated with significant improvements in faecal calprotectin, disease activity scores and quality of life after 8 weeks in adults with mild to moderate IBD. A growing body of evidence from in vitro and animal models suggests that food additive exposure damages the mucous layer of the gut wall and perturbs the microbial ecosystem.⁹ However, whether these findings translate to individuals with IBD is unknown.

STUDY ORIGINALITY/INNOVATION

Mild to moderate active ulcerative colitis (UC), commonly treated with mesalazine, only has symptomatic response rates of between 40%–70% and symptomatic remission rates of 15%–20%.^7,8 This pilot study’s novelty is in the combination of multi-omic rigorous basic science exploring the biology and predictors of treatment response, alongside a closely phenotyped newly diagnosed ulcerative colitis cohort with an easily translatable clinical question.  

AIMS

The primary aim of this pilot study is to determine whether a low food additive diet can improve symptomatic response as compared with a standard diet in patients with mild-moderate ulcerative colitis taking oral mesalazine treatment.  Secondary aims include: validation of a purposely developed food additive assessment tool through targeted metabolomic analysis of urine, stool and blood samples.