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 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.
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.
Dec 2019 Diet Intervention for Crohn's Disease Patient Interventional University of Miami The purpose of this study is to determine the effectiveness of a low-fat, high fiber diet (LFD) containing a minimal proportion of fat to improve gastrointestinal symptoms, quality of life and signs of inflammation in blood and stool.
Oct 2020 Modeling Patient Response to a Therapeutic Diet in Crohn's Disease (TDI) Interventional University of Calgary is proposed randomized controlled trial (RCT) explores the efficacy of a Crohn's Disease (CD) Therapeutic Dietary Intervention (TDI) compared to conventional management (CM) to induce steroid-free clinical remission at week 13 in patients with active, mild-to-moderate luminal CD. For asymptomatic patients with active disease, efficacy of the diet will be explored by using fecal calprotectin and sonographic findings.
May 2020 SCD vs. Mediterranean Diet Therapy in Ulcerative Colitis
Interventional SCD, MD Massachusetts General Hospital Although patients and physicians have shown tremendous interest in the effect of diet on ulcerative colitis, there is a lack of significant evidence for providers to make practical recommendations with. In this study, the investigators hope to find out if dietary therapy by either the Specific Carbohydrate Diet (SCD) or the Mediterranean diet will help improve ulcerative colitis symptoms for patients with mild to moderately active disease. In addition, the investigators will compare disease activity and changes in the intestinal bacterial composition in the colon that occur with the Mediterranean or the SCD diet in active ulcerative colitis.
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

Nutritional Therapy for IBD

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