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 ClinicalTrials.gov.
Date Title Trial type Completed Diets Sponsor Summary Excerpt Trial
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
Mar 2014 Personalized "Alberta" Diet for Prevention of Relapse in Ulcerative Colitis Interventional University of Alberta In the present study, ulcerative colitis (UC) patients in the remission stage of the disease will be randomized into two groups: Alberta anti-inflammatory diet and Canada's Food Guide diet. The elements of Alberta anti-inflammatory diet have previously been shown to have a role in decreasing the risk of UC development or management of UC-related symptoms or relapse. Since the primary outcome of interest is the relapse rate in two groups, disease status will be assessed monthly using appropriate tools. In order to find out the underlying mechanisms that will relate the proposed diet to decreased flare rate, some laboratory evaluations, which are mainly markers of inflammation or are related to gut microbiome will be conducted. In the present study, the investigators will also perform state-of-the art metabolomics tests, in order to study how the dietary changes will change the end metabolites. In addition, the investigators will be able to explore if metabolomic profile of participants can prThis study will last for 6 months from to their stable doses of maintenance drug therapy. N=53 completededict future UC relapse.
Jun 2017 Comparison of Partial and Exclusive Enteral Nutrition in the Treatment of Active Childhood-Onset Crohn's Disease Interventional EEN University Medical Centre Ljubljana The primary objective of this study is to determine the efficacy of a novel enteral nutrition (EN) protocol (delivering 75% of patient's caloric needs through EN) for induction of remission in patients with active childhood-onset Crohn's disease (CD) and compare it to the standard protocol with exclusive enteral nutrition (EEN). This novel approach allows patients to consume remaining calories (25%) from an antiinflammatory diet for CD (AID-CD). Randomized, open label n=50.
Jul 2016 Abnormal Fecal Microbiota in Healthy Subjects at High Risk for Crohn's Disease (MAGIC) Observational University Hospital, Lille Transversal multicentric French study on the microbiota in patients with Crohn's disease and their first degree healthy relatives The primary objective is the comparison of microbiota between patients with CD, healthy controls non genetically linked and first degree healthy relatives of patients with CD. The primary objective is the comparison of microbiota between patients with CD, healthy controls non genetically linked and first degree healthy relatives of patients with CD. The first endpoint is the Lachnospiraceae rates in each group. The secondary objectives are: 1. The search for an association between bacterial dysbiosis and different genetic backgrounds in patients with CD, their first degree healthy relatives and controls. 2. The quantification of potential invasive bacteria with invasive properties (E. coli including adherent-invasive E. coli, Shigella, Salmonella, Yersinia, Campylobacter), and fecal fungal flora (Candida albicans, in particular) and their association with genetic and serological profiles in patients with CD, their healthy relatives and control subjects. 3. A study of environmental risk factors using a questionnaire to be submitted to CD patients, their healthy relatives and control subjects. Observational n= 240.
Feb 2015 Decentralized Dietary UC Pilot Trial Interventional Transparency Life Sciences This study is designed to assess differences in remote and on-site patient study participation in the State of Massachusetts, as well as the significance of dietary interventions (Combined Anti-inflammatory Diet (CAID) and their impact on UC. The study will activate one site with a Principal Investigator who will utilize each subject's local care system (local Gastroenterologist) to collect study data, along with telemonitoring and video visits, to make key study assessments and decisions regarding subjects' progression in the study. Randomized, doiuble blind, n=51
Sep 2016 Fecal Microbiota Transplantation Improves Nutritional State of Patients With Crohn's Disease Interventional The Second Hospital of Nanjing Medical University Patients with Crohns' disease are always complicated with malnutrition. This trial aimed to assess whether FMT accompanied by enteral nutrition (EN) can make contributions to patients with Crohns' disease. Open label, n=60
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
Mar 2020 Prospective Dietary Therapy Using Crohn's Disease Exclusion Diet for Ileal Pouch Anal Anastomosis Patients Interventional CDED Tel-Aviv Sourasky Medical Center Although, pouchitis patients are former UC patients, the disease occurs in the small intestine, similarly to Crohn's disease (CD). Further, the disease can be clinically similar to CD, involving the proximal gastro-intestinal tract and causing strictures, fistula, or perianal disease. The Crohn's Disease Exclusion Diet (CDED) reduces exposure to all the components identified in rodent models as well as two components that are highly suspect but have not been investigated in models. The diet also provides dietary components that may favor species (especially SCFA producers) which appear to be deficient in CD. The investigator therefore aims to examine the microbial, mucosal and immunological changes of the pouch during one year post IPAA, and examine the impact of the CDED on disease activity and dysbiosis in a cohort of adults suffering from active pouchitis.
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
Nov 2019 Effects of an Intermittent Reduced Calorie Diet on Crohn's Disease Interventional Stanford University The purpose of this study is to see how an Intermittent Calorie Reduced Diet (IRCD) that mimics fasting effects inflammation in patients with mild to moderate Crohn's disease (CD). The diet may allow users to receive the benefits of fasting while also being able to enjoy food (the ingredients of which are GRAS (generally recognized as safe) by the Food and Drug Administration (FDA). Research on dietary interventions and CD are very limited. Diets that mimick fasting have been studied with support of the National Institute of Health and published in leading journals. This research investigates whether markers of inflammation decrease and/or quality of life increases after five-day periods of the IRCD, and may provide rationale for its use to treat CD. Three cycles of a 5-day Intermittent Reduced Calorie Diet over three months. Open label, n=75
Nov 2019 Effects of an Intermittent Reduced Calorie Diet on Crohn's Disease Interventional Stanford University The purpose of this study is to see how an Intermittent Calorie Reduced Diet (IRCD) that mimics fasting effects inflammation in patients with mild to moderate Crohn's disease (CD). The diet may allow users to receive the benefits of fasting while also being able to enjoy food (the ingredients of which are GRAS (generally recognized as safe) by the Food and Drug Administration (FDA). Research on dietary interventions and CD are very limited. Diets that mimick fasting have been studied with support of the National Institute of Health and published in leading journals. This research investigates whether markers of inflammation decrease and/or quality of life increases after five-day periods of the IRCD, and may provide rationale for its use to treat CD.n=75
Jan 2020 "Tasty and Healthy" Dietary Approach for Crohn's Disease
Interventional Shaare Zedek Medical Center The aim of this proposal is to explore the effectiveness of the "Tasty&Healthy" dietary approach based on avoiding "pro-inflammatory" and processed ingredients, for inducing and maintaining remission and MH in children and young adults.

Nutritional Therapy for IBD

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