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Abstract Background Food additive emulsifiers result in bacterial dysbiosis, reduced intestinal mucus thickness, microbiota encroachment and increased permeability resulting in intestinal inflammation in murine models. Dietary intervention trials in inflammatory bowel disease are limited by challenges with blinding, high placebo response rates and because changes to one diet component impact on intake of many others (dietary collinearity). The ADDapt trial aimed to investigate the effects of a low emulsifier diet (LED) compared to control diet for 8-weeks on disease activity in patients with mild/moderately active Crohn’s disease (CD). Methods ADDapt (NCT04046913) was an appropriately powered, randomised, double-blind, placebo-controlled, re-supplementation trial (n=154). Patients with a CD activity index (CDAI) of 150-250 plus objective evidence of inflammation (faecal calprotectin (FCP) ≥150 µg/g or endoscopy/radiology) were randomised to either LED (intervention) or LED plus emulsifier re-supplementation (control). Dietary counselling was provided by a dietitian, plus dietary resources and a mobile app to support shopping. To recreate habitual emulsifier intake in controls, both groups received supermarket deliveries for 25% of foods either containing no emulsifiers (intervention) or similar foods containing emulsifiers (control) and were provided three snacks per day that were either emulsifier-free (intervention) or contained carrageenan, carboxymethylcellulose and polysorbate-80 (control). The primary endpoint was the proportion of patients achieving CDAI response (≥70 reduction) at 8-weeks. Secondary endpoints included CDAI remission and FCP. Regression analyses (adjusting for confounders) assessed the difference between trial arms. Results Patients (n=154, ITT population) were recruited from 19 UK centres with 113 (73%) completing the 8-week trial (PP population). Emulsifier intake reduced from median 30.0 (IQR 33.0) to 2.5 (6.0) in the LED group (p0.001). In the ITT analysis, the primary outcome of CDAI response was achieved in 39 (49.4%) on LED versus 23 (30.7%) in the control group (p=0.019), with an adjusted relative risk (RR) of response of 3.1 (95% CI 1.5, 6.6, p=0.003), a finding that persisted in the PP analysis. In the ITT analysis, compared to control, patients on a LED were more than twice as likely to experience CDAI remission (Adjusted RR 2.1; 95% CI 1.0, 4.4; p=0.042) and 50% reduction in FCP (Adjusted RR 2.9; 95% CI 1.1, 8.0; p=0.039) (Table 1). There were no serious adverse events. Conclusion A LED is an effective treatment in mild/moderately active CD. Ongoing mechanistic analyses will investigate the impact of the LED on gut microbiota and permeability. Funding The Leona M. and Harry B. Helmsley Charitable Trust
Bancil et al. (Wed,) studied this question.