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 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, 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.
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.
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
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
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.
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.
Sep 2019 Biomarker-based Multidisciplinary Team (Bio-MDT) Approach to Personalized Microbial-targeted Treatment of Pouchitis and Crohn's Disease (Bio-MDT) Interventional SCD Rabin Medical Center We hypothesized that personalized antibiotics and dietary interventions will modify microbial composition and result in significantly improved outcomes, specifically resolution of inflammation and prolonged remission rates in patients with a pouch. Aims: 1. Compare the effect of two antibiotic treatments on clinical, inflammatory and microbiological outcomes of patients with pouch inflammation. 2. Evaluate the effect of combined microbiome-targeted antibiotic and dietary intervention as treatment and prevention strategy in patients after pouch surgery. 3. Evaluate the effect of a microbiome-targeted dietary intervention as prevention strategy in patients after pouch surgery. 4. Identify predictors for response to specific antibiotic and dietary interventions.

Nutritional Therapy for IBD

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