Determining the optimal treatment target in patients with ulcerative colitis: rationale, design, protocol and interim analysis for the randomised controlled VERDICT trial.

INTRODUCTION: Symptoms, endoscopy and histology have been proposed as therapeutic targets in ulcerative colitis (UC). Observational studies suggest that the achievement of histologic remission may be associated with a lower risk of complications, compared with the achievement of endoscopic remission alone. The actiVE ulcerative colitis, a RanDomIsed Controlled Trial (VERDICT) aims to determine the optimal treatment target in patients with UC. METHODS AND ANALYSIS: In this multicentre, prospective randomised study, 660 patients with moderate to severe UC (Mayo rectal bleeding subscore [RBS] ≥1; Mayo endoscopic score [MES] ≥2) are randomly assigned to three treatment targets: corticosteroid-free symptomatic remission (Mayo RBS=0) (group 1); corticosteroid-free endoscopic remission (MES ≤1) and symptomatic remission (group 2); or corticosteroid-free histologic remission (Geboes score <2B.0), endoscopic remission and symptomatic remission (group 3). Treatment is escalated using vedolizumab according to a treatment algorithm that is dependent on the patient's baseline UC therapy until the target is achieved at weeks 16, 32 or 48. The primary outcome, the time from target achievement to a UC-related complication, will be compared between groups 1 and 3 using a Cox proportional hazards model. ETHICS AND DISSEMINATION: The study was approved by ethics committees at the country level or at individual sites as per individual country requirements. A full list of ethics committees is available on request. Study results will be disseminated in peer-reviewed journals and at scientific meetings. TRIAL REGISTRATION NUMBER: EudraCT: 2019-002485-12; NCT04259138.

Food Insecurity Negatively Impacts Gluten Avoidance and Nutritional Intake in Patients With Celiac Disease.

BACKGROUND: Food insecurity is a major public health challenge. For patients with celiac disease (CeD), food insecurity may be particularly detrimental as it threatens the cornerstone of their treatment: adoption of a gluten-free diet (GFD). We aimed to characterize the prevalence of food insecurity in patients with CeD and evaluate its impact on GFD adoption and nutritional intake. METHODS: We analyzed data from patients with CeD participating in the US National Health and Nutrition Examination Survey (NHANES) from 2009 to 2014. Food insecurity was defined using the US Department of Agriculture 18-Item Standard Food Security Survey Module. Survey-weighted logistic regression was used to assess differences in demographic characteristics of CeD patients living with food insecurity and the impact of food security on GFD adoption. Multivariable survey-weighted linear regression was used to evaluate the effect of food insecurity on nutritional intake of macronutrients and micronutrients. RESULTS: Overall, 15.9% (95% confidence interval: 10.6%, 23.1%) of patients with CeD in the United States [weighted N=2.9 million (95% confidence interval: 2.2, 3.5 million)] are food insecure. Food insecure patients with CeD were disproportionately younger, poorly educated, nonwhite, living in poverty, and were significantly less likely to adopt a GFD (24.1% vs. 67.9%, P =0.02). Food insecurity was associated with significantly lower consumption of protein, carbohydrates, fat, and most vitamins and minerals. CONCLUSIONS: One in 6 patients with CeD are food insecure, negatively impacting GFD adoption and the ability to meet recommended daily intake of most micronutrients. Less than one quarter of food insecure CeD patients adhere to a GFD.