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
May 2019 Inflammatory Bowel Disease Tracker (IBD Tracker) (IBDTr) Observational Massachusetts General Hospital The goal for this study is to use non-invasive monitoring techniques to identify biomarkers that emerge, or change predictably, when a patient begins to relapse from remission to enter a period of disease - to find the earliest signs of an active flare. If the investigators identify a pattern of biomarkers that could alert a patient and their clinician to a flare as soon as it begins, it may be possible to intervene before symptoms present by changing medication and/or diet and lifestyle to lessen the severity of the disease flare. The biomarker fingerprint may also reveal new targets for therapeutics that could control IBD. Patient reported well being, 24 hour dietary recall, Smart Watch monitoring for activity, sleep, movement. Blood, stool, urine biomarkers measured throughout 12 month period, as well as biospecimens for microbiome and metabolite composition. Observational, prospective, 12 months, N=100
Jul 2018 Immunonutrition in Ulcerative Colitis Interventional Baptist Memorial Health Care Corporation This study tests the hypothesis that a supplement that combines a functional fiber, long chain omega-3 polyunsaturated fatty acids (PUFAs), vitamin D3, vitamin E, and zinc will reduce clinical symptoms, decrease pro-inflammatory cytokines in the blood and ergo decrease inflammation, promote beneficial microbial activity in the colon, and help recovery of the intestinal mucosa of ulcerative colitis (UC) patients compared with a placebo. Randomized, single masked, n=30
Apr 2016 Fecal Transplantation Using a Diet for Donor and Recipient in Refractory Colitis Interventional Wolfson Medical Center The investigators propose to modify FT using a novel protocol and approach that we have developed. We have developed a unique diet that is geared to rectify dysbiosis in UC and damage to the mucous layer in active UC. The investigators intend to condition both donor and recipient with the diet to achieve optimal conditions for transplant to succeed for both donor and recipient .The investigators intend to evaluate this protocol in adults with active UC that are refractory to medications. The investigators will start with a randomized controlled trial involving 76 transplanted patients, however in the first pilot stage The investigators will enroll 34 patients, and extend the study if there is a trend for better outcomes with the dietary conditioning protocol. Furthermore, The investigators hope to identify successful donors during this period to use during the study extension.
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
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
Apr 2015 Dietary Therapy and Gut Microbiome in Crohn's Disease and Ulcerative Colitis Interventional SCD Massachusetts General Hospital Single site, open-label clinical trial of enteral nutrition or the specific carbohydrate diet in patients with active CD or UC assigned to one of two dietary intervention arms based on their preference and will meet with the study registered dietician at the MGH Clinical Research Center (CRC) metabolism and nutrition unit. There, they will receive instruction on the components of the assigned dietary therapy arm - partial elemental diet (enteral nutrition) or specific carbohydrate diet, and will complete a baseline food record (FR). They will adhere to the dietary therapy for 6 weeks after which they can resume normal diet. Clinical, biochemical, nutritional, and microbiological parameters will be measured during and for 6 weeks following the study. They will have 5 study visits during this time. N=40
Jul 2016 Diet for Induction and Maintenance of Remission and Re-biosis in Crohn's Disease (DIETOMICS-CD) Interventional CDED, EEN, PEN Prof. Arie Levine The modified-Exclusive Enteral Nutrition (mEEN) is an open label randomized controlled pilot trial in mild to severe Crohn's Disease patients. The purpose of this study is to determine whether induction of remission and maintenance of remission can be achieved with a new dietary strategy that involves only 2 weeks of Exclusive Enteral Nutrition (EEN) with Modulen followed by an exclusion diet involving selected table foods, coupled with partial enteral nutrition for 24 weeks. This novel approach will be compared to the gold standard dietary regime involving 8 weeks of EEN followed by PEN with free diet. N=76
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
Dec 2012 Diet and Disease Activity in Patients With Inflammatory Bowel Disease Observational Maastricht University Medical Center The investigators hypothesize that differences in dietary patterns affects the intestinal microbiota composition and thereby contributes to the development of exacerbations in IBD. Observational cohort, 1 year, n=600.
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 2019 Diet Intervention Treatment for Active Ulcerative Colitis Interventional Mount Sinai Hospital, Canada We propose to use a sustainable non-elemental diet aimed at altering the microbiome in patients with mild to moderately active UC to alter their disease activity. Participants will be followed for 14 days on their traditional diet followed by an 8 week intervention with the specially designed and provided treatment diet. The treatment diet has been designed based on the literature with the goal of influencing the biodiversity and density of the microbiome. All food through the duration of the 8 week dietary intervention period of the study will be provided to the treatment arm study participants. Open label n=20

Nutritional Therapy for IBD

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