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
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
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.
May 2020 SCD vs. Mediterranean Diet Therapy in Ulcerative Colitis
Interventional SCD, MED 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.
Apr 2018 Reverse Engineering of Exclusive Enteral Nutrition (RE-EEN) Interventional EEN Dale Lee This will be an open label, pilot study over 4 weeks in children with newly diagnosed Crohn's disease treated with a smoothie designed to emulate formulas used for exclusive enteral nutritional therapy. In place of formula, whole-foods based smoothie recipes and the food to create the smoothies will be given to each participant/family. The smoothies will be based upon the concept of reverse-engineering of exclusive enteral nutrition (RE-EEN). The smoothie recipes will involve whole foods that can be blenderized to liquid consistency. Similar to the formulas used for EEN, the smoothies will provide calories, protein, fat, and carbohydrates in a distribution to support growth and development. Patients will be evaluated for induction of remission and changes in microbiome. Open label, n=10
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.
Sep 2014 Pilot Study of Partial Enteral Nutrition With a Unique Diet for the Treatment of Adult Patients With Crohn's Disease (CDED-ADULTS) Interventional CDED Prof. Arie Levine At present, data about nutritional therapy and this new dietary approach have been generated primarily in children, and this new diet has not been evaluated for early mucosal healing. The objectives of this pilot study are to generate data in adults, evaluate the diet over a longer period of time (24 weeks) and evaluate mucosal healing. The study is a prospective open label randomized controlled pilot trial in adults, with mild to moderate Crohn's disease who will receive the Crohn's Disease Exclusion Diet (CDED) for 24 weeks. If effective, this could enable use of a feasible, safe intervention for induction and maintenance of remission as a new therapy or as an adjunctive therapy with medical therapy. n=40
Oct 2017 Personalized Research on Diet in Ulcerative Colitis and Crohn's Disease (PRODUCE) Interventional SCD, mSCD Children's Hospital Medical Center, Cincinnati A series of N-of-1 trials will be used to determine the effectiveness of a specific carbohydrate diet (SCD) versus a modified SCD in patients in reducing symptoms and inflammatory burden at both the individual and population level. This is a three-year study. The study staff will recruit 120 patients (goal sample size of 100, accounting for attrition) across up to 12 sites in patients aged 7-17 with mild to moderate disease activity. Randomized, open label, crossover trial.
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.
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.
Oct 2016 Microbiota-targeted Diet for Pediatric UC (UCD) Interventional Children's Hospital of Philadelphia Diet has a significant impact on the composition of the microbiota; The primary objective of this study is to determine whether the Ulcerative Colitis Diet (UCD) can induce remission or response in pediatric UC patients with active mild to moderate UC on a stable medication. 12 weeks open label n=47
Jul 2016 Mediterranean Diet as an Add-on Therapy for Induction of Remission in Patients With Active Crohn's Disease Interventional MED michal roll The purpose of this study is to determine whether Mediterranean diet is superior to a low residue diet as an add-on therapy for induction of remission in adult patients with active Crohn's disease and to evaluate its effects on clinical, inflammatory and microbial parameters. Seventy eligible patients will be randomly assigned to one of two dietary interventions: Mediterranean diet or low residue diet, as an add-on therapy for induction of remission of active Crohn's disease. The effect of the dietary regimens on clinical, inflammatory and microbial parameters will be assessed at 8 and 52 weeks.Randomized, double-blind. n=100
Jan 2020 Low Animal Protein(LAP) modified Specific Carbohydrate Diet in Pediatric Ulcerative Colitis Interventional SCD David Suskind, Seattle Children's Hospital For this study, the investigators will examine the effect of low animal protein diet modified SCD in active ulcerative colitis. The investigators are examining how well a LAP SCD is tolerated and whether the LAP SCD appears effective for the treatment of active UC. Patients will be evaluated at 2, 4, 8, and 12 weeks with CBC, sedimentation rate, C-reactive protein, albumin, and stool for microbiome analysis at each follow up visit.

Nutritional Therapy for IBD

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