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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
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.
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
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.
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.
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.
Aug 2016 The Effect of Diet on Microbial Profile and Disease Outcomes in Patients With Inflammatory Bowel Diseases Interventional SCD Tel-Aviv Sourasky Medical Center This clinical study is designed to evaluate the effect of two dietary patterns, Mediterranean diet and the specific carbohydrate diet on clinical, inflammatory and microbial parameters in patients after pouch surgery and to assess the effect of a personal tailored diet, based on microbial profile, on disease outcomes and generate a predictive model for future interventions. Seventy ulcerative colitis patients post restorative proctocolectomy (pouch) will be randomly allocated into two short-term (one week) dietary interventions, the Mediterranean diet and the specific carbohydrate diet, to assess which diet has the required influence (i.e. increased diversity, decrease in specific pathobionts and increase in "anti-inflammatory" taxa) on the gut microbiome of each participant. Based on this assessment, each participant will be treated by a personally-tailored diet for up to one year, during which microbial composition, clinical parameters, and quality of life will be assessed. Randomized, double blind crossover, n=70
Feb 2017 Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission of Crohn's Disease (DINE-CD) Interventional ✔ SCD, MD University of Pennsylvania This protocol is designed to compare the effectiveness of two dietary interventions for patients with Crohn's disease (CD): the Specific Carbohydrate Diet (SCD) and a Mediterranean style diet (MSD) that has been demonstrated to have numerous other health benefits. The two diets will be compared in terms of their ability to resolve both the symptoms and bowel inflammation that characterize this debilitating disease. Randomized, open label n=194

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