Clinical Trial: The Effects of Emulsifiers in the Food Supply on Disease Activity in Crohn's Disease: An Exploratory Double‐Blinded Randomised Feeding Trial

Abstract

BackgroundAdvice to avoid dietary emulsifiers in Crohn's disease (CD) is based on preclinical data.AimsTo examine the effect of diets high (HED) and low (LED) in emulsifiers in the food supply on disease activity in CD.MethodsIn a double‐blinded, randomised feeding study, we randomised adults with symptomatic, sonographically active CD with ileal involvement on ≥ 2 months' stable medical therapy to 4 weeks of a HED or LED modelled on Australian healthy eating guidelines. We measured the Harvey‐Bradshaw Index (HBI), sonographic indices (IBUS‐SAS, bowel wall thickness), quality of life (QOL) and fatigue at baseline and study completion.ResultsWe randomised 24 patients, mean age 37 (95% CI 32, 41) years, 12 male, HBI 6 (6, 8), bowel wall thickness 6.0 (5.5–6.6) mm. Adherence was > 95%. Clinical remission (HBI < 5) occurred in 9/12 on HED and 7/12 on LED; 2 and 3, respectively, withdrew early with increasing gastrointestinal symptoms. IBUS‐SAS fell from 51 (35, 68) to 33 (15, 51) on HED (p = 0.014) and from 57 (38, 76) to 44 (29, 59) on LED (p = 0.01). Bowel wall thickness reduced by 34% on HED and 15% on LED in those who completed the study. QOL and fatigue improved on both diets (p ≤ 0.05). There were no statistically significant differences in outcomes between diets.ConclusionsIn the context of a healthy diet, the emulsifier content had no influence over disease activity over 4 weeks in patients with CD. Recommendations to avoid emulsifiers in patients with active CD are not supported.Australian New Zealand Clinical Trials Registry (ACTRN12619001099112).