Ongoing Clinical Trials

The body of research examining therapeutic diets is growing. Many trials are still in progress, including several large multi-center trials (DIETOMICS-CD [CDED] and MELODY [IBD-AID]). The collection of ongoing clinical trials listed below has been cultivated from
Date Title Trial type Completed Diets Sponsor Summary Excerpt Trial
Oct 2016 The Challenge Study: A Dietary Personalization Protocol for Patients With Crohn's Disease and Deep Remission Interventional CDED Wolfson Medical Center Prospective, open label, pilot trial in patients in deep remission on dietary maintenance therapy. The purpose of this study is to determine whether they can consume some of the products that were eliminated from their diet, named the Crohn's Disease Exclusion Diet (CDED), and to evaluate if low dose exposure is harmful. The investigators have now progressed to three randomized controlled trials to evaluate the diet in different populations with different disease severity, and the results from the first RCT demonstrate a high remission rate in the CDED arm. However, to date the investigators have used the same diet for all patients. The investigators are now encountering patients on the diet in deep remission, but the investigators do not know if they can consume some of the products (such as milk fat and gluten) that were eliminated. The investigators therefore are starting to challenge our patients in deep remission with low dose exposure to evaluate if low dose exposure is harmful. The investigators wish to document this and obtain stool samples for calprotectin and microbiome n=10
Mar 2018 The ENIGMA Study: Eastern Inflammatory Bowel Disease Gut Microbiota Observational Chinese University of Hong Kong The ENIGMA project comprises three main enteric microbiome domains of central importance to Crohn's disease. Two specific organisms which may play a critical role in disease pathogenesis, including the candidate protective bacterium, and the novel pathogenic candidate, will be characterised and studied in detail. Microbial findings will be related to detailed assessment of environmental factors that permit microbial changes or expression. Observational cohort, n=1300
Feb 2017 The Effect of Diet on Disease Activity and Symptoms in Patients With Ulcerative Colitis Interventional University of British Columbia The Mediterranean Diet Pattern (MDP) is associated with improvements in health status and inflammatory markers in healthy individuals and rodent models of colitis. Reductions in inflammatory biomarkers and a "normalization" of the gut microbiota have been shown in patients with Crohn's disease following a MDP. To date, no studies have examined the effect of MDP on disease activity, inflammatory markers or the effects on the microbiome in ulcerative colitis (UC). This study will examine the effects of a MDP taken by patients with UC on 1) symptoms, clinical and quality of life endpoints and 2) on gut microbiome and fecal immune biomarkers. One hundred subjects and two subjects with UC will be randomly allocated to follow a MDP for 12 weeks or their usual diet (controls). Upon initiation, throughout and completion of each diet, symptoms, clinical and quality of life endpoints will be monitored. Fecal samples will be collected to assess pH, short-chain fatty acid concentrations, bacterial abundance and diversity. . Randomized, open label, n=102
Aug 2016 The Effect of Diet on Microbial Profile and Disease Outcomes in Patients With Inflammatory Bowel Diseases Interventional SCD Tel-Aviv Sourasky Medical Center This clinical study is designed to evaluate the effect of two dietary patterns, Mediterranean diet and the specific carbohydrate diet on clinical, inflammatory and microbial parameters in patients after pouch surgery and to assess the effect of a personal tailored diet, based on microbial profile, on disease outcomes and generate a predictive model for future interventions. Seventy ulcerative colitis patients post restorative proctocolectomy (pouch) will be randomly allocated into two short-term (one week) dietary interventions, the Mediterranean diet and the specific carbohydrate diet, to assess which diet has the required influence (i.e. increased diversity, decrease in specific pathobionts and increase in "anti-inflammatory" taxa) on the gut microbiome of each participant. Based on this assessment, each participant will be treated by a personally-tailored diet for up to one year, during which microbial composition, clinical parameters, and quality of life will be assessed. Randomized, double blind crossover, n=70
Apr 2017 The IMAGINE-SPOR CIHR Chronic Disease Network (IMAGINE) Observational Hamilton Health Sciences Corporation The IMAGINE Cohort Study will identify and recruit a cohort of 8000 patients with IBS, IBD and healthy controls (2000 of each) who will be assessed in terms of their psychological status, dietary intake, gut microbiome, metabolomic and inflammatory markers and genotype, health-related quality of life, and health care resource use and associated costs. The cohort and healthy controls will be followed prospectively for up to 5 years after the completion of study enrollment. Observational cohort. n=8000.
Feb 2020 The Impact of Time Restricted Feeding in Crohn's Disease (TRF-CD) Interventional Weill Medical College of Cornell University Collaborator: Time-restricted feeding (TRF) is a dietary regimen involving the consumption of food and liquids within a defined time window with or without additional restriction on dietary composition. TRF has been associated with improvements in inflammation, host metabolism, autophagy, gut microbial composition, and gut permeability. Crohn's disease is an inflammatory bowel disease of unknown etiology that likely results from a combination of genetic and environmental factors. This proposed study will test the hypothesis that a time-restricted feeding regimen will improve clinical outcomes and favorably influence the gut microbiome in patients with active Crohn's disease. If time-restricted fasting proves beneficial to this patient population then it will pave the way for larger, prospective studies and clinical trials.
Aug 2018 The Influence of a Fasting Mimicking Diet on Ulcerative Colitis Interventional Stanford University This research investigates whether markers of inflammation decrease and/or quality of life increases after three cycles of a five-day period of the fasting mimicking diet, and may provide rationale for its use to treat UC. Three cycles of a 5-day reduced calorie diet over 3 months. Primary outcome; changes in CRP, FCP, ESR. Secondary outcome: clinical remission per Mayo score, endoscopic outcomes. Other outcomes: measure of additional inflammatory markers, changes in gut metabolites and microbiome profiles. Open label, n=75
Jan 2020 The Intensive Post Exclusive Enteral Nutrition Study (iPENS) Interventional CD-TREAT NHS Greater Glasgow and Clyde The aim of this study is to investigate this phenomenon by exploring if diet and gut bacteria play a role. Furthermore, the investigators aim to test whether a new, ordinary food-based diet, called the Crohn's Disease TReatment with EATing (CD-TREAT) diet can help control gut inflammation during the early food reintroduction phase, after EEN completion, compared to an unrestricted, free diet.
Feb 2019 The MELODY Trial: Modulating Early Life Microbiome Through Dietary Intervention in Crohn's Disease
Interventional IBD-AID Icahn School of Medicine at Mount Sinai The goal of this study is to prospectively test the hypothesis that a non-invasive dietary intervention during the last trimester of pregnancy could beneficially shift the microbiome of CD and UC patients and their babies, hereby promoting a healthier immune system during a critical time of the immune system development. Particularly, the study team will test whether favorable diet-driven changes in the microbiome can lead to a reduced risk of postpartum relapse and lower gut inflammation in the offspring. The study design is a three-arm, prospective, pre-post intervention trial. Crohn's Disease (CD) patients at 27-29 weeks of pregnancy will self-select to Arm 1 or Arm 2. Controls will be in Arm 3. Arm 1 (diet-CD): 8-10 weeks of dietary intervention (n=66) Arm 2 (no-diet-CD): usual diet with no intervention (n=66) Arm 3 (no-diet-control): unaffected controls at the same gestational stage will follow their usual diet and no intervention (n=66). This study has been updated to include mothers with UC in addition to mothers with CD.
Sep 2017 The PRognostic Effect of Environmental Factors in Crohn's and Colitis (PREdiCCt) Observational University of Edinburgh This is a major study that is now being launched. This is the first study of its kind and is specifically directed toward understanding how environmental factors and the gut microorganisms influence IBD flare and recovery. For the PREdiCCt study, the investigators hope to recruit 1500 people in remission from Crohn's disease or ulcerative colitis (illness under control) from 28 inflammatory bowel disease clinics across the UK. What investigators hope to achieve: 1. Finding out the environmental and dietary factors for patients to avoid because they trigger flare. 2. Finding out behaviours for patients to adopt because they bring about remission. 3. Finding out what the microorganisms that predict flare look like. 4. Gaining information which helps future studies aimed at finding better diets for IBD sufferers. 5. Developing ways of gathering information online from IBD patients about their well-being that doctors can routinely use. Observational cohort, n=3100
Jan 2015 Use of a Novel Diet (UC DIET) for Treatment of Mild to Moderate Active Pediatric Ulcerative Colitis Interventional Prof. Arie Levine The goal of the study is to evaluate strategies that target the microbiota for the treatment of Ulcerative Colitis , This study will involve a novel diet that the investigators developed , based on the hypothesis that UC involves dysbiosis , underutilzation of certain metabolic pathways and use of pathways that increase risk of inflammation . The investigators have postulated that manipulation of colonic bacterial metabolism with this diet will induce remission in UC without involving additional immune suppression. Open label n=20
Jul 2019 Vegetarian Diet in Ulcerative Colitis (LOVUC) Interventional Edith Cowan University To determine whether a lacto-ovo vegetarian diet is effective in improving gastrointestinal symptoms, quality-of-life, intestinal inflammation and gut microbiota composition in mild-to-moderate UC compared to a standard omnivorous diet. This study will review whether a lacto-ovo vegetarian diet is an optimal dietary therapy to achieve a clinical response in mild to moderate UC as an adjunctive treatment to current medical therapies. The proposed RCT will be used to evaluate the efficacy of a lacto-ovo vegetarian diet together with its effect on the microbiota to create an enhanced understanding of the role diet plays in the management of UC. Using a socially acceptable diet it is anticipated that food-related quality-of-life measures will improve for participants. Dietary modification could be a more economical, safer and more effective means of reducing symptoms and flare-ups compared to pharmacological therapy. Phase 1: Open labelled, single centre trial (10 patients) Phase 2: Open labelled, single centre, single blinded, randomised controlled clinical trial (n=30).

Nutritional Therapy for IBD

Improving the Care of Patients with Crohn’s Disease and Ulcerative Colitis through Diet