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
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).
Jan 2017 Diet as Essential Therapy (DIET) for Inflammatory Bowel Disease Interventional University of Washington The investigators propose to evaluate two such diets (certain diets have been recommended for patients with Crohn's disease) by randomizing 32 subjects with mildly to moderately active Crohn's disease to one of two diets that differ in the amount and type of carbohydrates and fiber. Subjects will remain on the diet for 8 weeks and will be evaluated for changes from baseline in inflammatory biomarkers, symptomatic disease activity, and the microbiome. Randomized, quadruple masked, n=34
Mar 2018 Chronic Inflammatory Disease, Lifestyle and Risk of Disease (PROCID-DHC) Interventional University of Southern Denmark The study will use data from all of the 57,053 participants in the Danish cohort "Diet, Health and Cancer (DHC)" together with registry data. Blood samples, anthropometric measures and questionnaire data on diet and lifestyle were collected at the DHC study entry. The National Patient Registry (NPR) will be used to obtain to identify patients with CID during follow-up. Follow-up information on death and immigration will be collected in March 2018 from the Danish Civil Registration Register. The outcome of Chronic Inflammaroty Diseases (CID) is defined as at least one of the following CIDs: Crohn's disease, ulcerative colitis, psoriasis/psoriatic arthritis, rheumatoid arthritis/ankylosing arthritis, or multiple sclerosis, during the follow-up period from 1993 to March 2018. The primary hypothesis is that "the risk of CID will be significantly higher among those with a low fibre/high red and processed meat intake compared to those with a high fibre/low red and processed meat intake." Based on previous research on a shared etiology in CIDs a second hypothesis is that "the postulated causality between low fibre/high red and processed meat intake and risk of developing CID is applicable for each of the CID-diagnoses." Observational, prospective, 24 years, n=57,053
Jun 2015 Crohn Disease Exclusion Diet After Single Medication De-escalation (CEASE) Interventional CDED Children's Hospital of Philadelphia Diet has been proven to impact disease activity in CD and may allow for sustained drug-free remission. The primary objective of this study is to determine whether pediatric CD patients in long-standing remission remain in remission longer after stopping medications if they follow the Crohn's Disease Exclusion Diet (CDED). The hypothesis is that subjects on the CDED will have longer time-to-relapse as opposed to those on an unrestricted diet. n=35
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.
Jul 2014 Cyclic Exclusive Enteral Nutrition as Maintenance Therapy for Pediatric Crohn’s Disease (CD-HOPE) Interventional EEN Assistance Publique - Hôpitaux de Paris There is convincing data indicating that EN is highly efficacious when given on an exclusive basis, while the use of partial EN is markedly less effective to induce remission in active Crohn's disease as compared to exclusive EN. Recently, it was suggested that exclusive EN has a dominant effect on the intestinal microbiota, which contributes to the induction of remission. There exists several strategies to maintain remission in children with CD, but there is no clear consensus on which maintenance treatment to follow. There are some indicators to believe that enteral nutritional therapy might play also a significant role as maintenance therapy for CD. Given the fact that many centers use a top-down approach with the introduction of immunosuppressors and/or biologics at/or shortly after diagnosis, the investigators wanted to test the possibility of a treatment option to efficiently maintain remission with less (or no) side effects based on enteral nutrition to avoid the early use of immunosuppressors.
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.
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.
Jun 2020 Study of Dietary Composition in Crohn's Disease (CD)
Interventional University of California, Los Angeles A randomized controlled trial of the anti-inflammatory whole food diet versus usual diet for the induction of remission in 104 adults with mild-to-moderate Crohn's Disease (CD). The anti-inflammatory whole food diet will be compared to participants usual diet for understanding its effects on achieving clinical remission, clinical response, reduction in serological and fecal markers of inflammation, and improvement in patient-reported outcomes, such as physical activity, anxiety, depression, fatigue, pain, sleep disturbance, social satisfaction, and quality of life. The study will involve collection of blood and fecal specimens to evaluate the effects of the anti-inflammatory diet on the gut microbiome, bacterial metabolome, innate immune markers, and fecal microRNA profiles. The participants will be placed on anti-inflammatory diet for 8 weeks and assessed every 2 weeks for adherence.
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.
Jan 2020 Adjunctive Treatment With Vitamin D3 in Patients With Active IBD (ACTIVATED) Interventional Massachusetts General Hospital Besides its traditional role in bone homeostasis, several studies have recognized the important role Vitamin D plays in modulating the immune response, cancer, and cardiovascular disease. Specifically, Vitamin D may mediate immunity by modulating autophagy in leukocytes and regulating the gut microbiome. Thus, Vitamin D may play an important role in IBD. Furthermore, evidence suggests that the effect of vitamin D may be mediated through the TNF-α pathway, suggesting a synergy with anti-TNF therapy. This is a randomized, double blind, placebo-controlled trial to study the effect of Vitamin D3 as an adjunct therapy for patients with active CD, UC, or IBD unspecified who are undergoing anti-TNF induction therapy.
Jul 2019 Vegetarian Diet in Ulcerative Colitis (LOVUC) Interventional Edith Cowan University 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.

Nutritional Therapy for IBD

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