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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
Feb 2018 Combined Nutritional Therapies for the Treatment of Ulcerative Colitis Interventional AB Biotics, SA The study will include two groups of 20 patients each. One of the groups will receive 6 grams of fiber a day in a single shot with the main meal (group 1) and the other group will receive 12 grams of fiber a day divided into two meals with the main meals (group 2). Two different combinations of fibers (formula A and B) will be tested with the following administration pattern for both groups. Description of the administration pattern Week 1: Formula A Week 2: Formula A Week 3: Formula B Week 4: Formula B A second sequential cycle similar to the first one (4 weeks with the same administration pattern) will be repeated in order to confirm the reproducibility of the findings. The two formulas contain fibers known and commonly used in human nutrition, which were previously tested in in vitro models with human faeces and their ability to promote the growth of butyrate-producing bacterial species that are deficient in patients with colitis was proven ulcerative (Faecalibacterium prausnitzii and Roseburia hominis). The fibers are presented in aluminum envelopes to dissolve in a glass of water, juice, infusion or cold cream (max 37 ° C). In addition, formulas A and B for group 1 (a single intake per day) include the mixture of probiotics i3.1 in quantity per envelope of 3e + 9 colony-forming units, which contains: Pediococcus acidilactici CECT 7483, Lactobacillus plantarum CECT 7484 and Lactobacillus plantarum CECT 7485 in a 1: 1: 1 ratio.Randomized, open label, 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.
Sep 2017 The PRognostic Effect of Environmental Factors in Crohn's and Colitis (PREdiCCt) Observational University of Edinburgh This is a major study that is now being launched. This is the first study of its kind and is specifically directed toward understanding how environmental factors and the gut microorganisms influence IBD flare and recovery. For the PREdiCCt study, the investigators hope to recruit 1500 people in remission from Crohn's disease or ulcerative colitis (illness under control) from 28 inflammatory bowel disease clinics across the UK. What investigators hope to achieve: 1. Finding out the environmental and dietary factors for patients to avoid because they trigger flare. 2. Finding out behaviours for patients to adopt because they bring about remission. 3. Finding out what the microorganisms that predict flare look like. 4. Gaining information which helps future studies aimed at finding better diets for IBD sufferers. 5. Developing ways of gathering information online from IBD patients about their well-being that doctors can routinely use. Observational cohort, n=3100
Jun 2017 Comparison of Partial and Exclusive Enteral Nutrition in the Treatment of Active Childhood-Onset Crohn's Disease Interventional EEN University Medical Centre Ljubljana The primary objective of this study is to determine the efficacy of a novel enteral nutrition (EN) protocol (delivering 75% of patient's caloric needs through EN) for induction of remission in patients with active childhood-onset Crohn's disease (CD) and compare it to the standard protocol with exclusive enteral nutrition (EEN). This novel approach allows patients to consume remaining calories (25%) from an antiinflammatory diet for CD (AID-CD). Randomized, open label n=50.
Apr 2017 The IMAGINE-SPOR CIHR Chronic Disease Network (IMAGINE) Observational Hamilton Health Sciences Corporation The IMAGINE Cohort Study will identify and recruit a cohort of 8000 patients with IBS, IBD and healthy controls (2000 of each) who will be assessed in terms of their psychological status, dietary intake, gut microbiome, metabolomic and inflammatory markers and genotype, health-related quality of life, and health care resource use and associated costs. The cohort and healthy controls will be followed prospectively for up to 5 years after the completion of study enrollment. Observational cohort. n=8000.
Feb 2017 The Effect of Diet on Disease Activity and Symptoms in Patients With Ulcerative Colitis Interventional University of British Columbia The Mediterranean Diet Pattern (MDP) is associated with improvements in health status and inflammatory markers in healthy individuals and rodent models of colitis. Reductions in inflammatory biomarkers and a "normalization" of the gut microbiota have been shown in patients with Crohn's disease following a MDP. To date, no studies have examined the effect of MDP on disease activity, inflammatory markers or the effects on the microbiome in ulcerative colitis (UC). This study will examine the effects of a MDP taken by patients with UC on 1) symptoms, clinical and quality of life endpoints and 2) on gut microbiome and fecal immune biomarkers. One hundred subjects and two subjects with UC will be randomly allocated to follow a MDP for 12 weeks or their usual diet (controls). Upon initiation, throughout and completion of each diet, symptoms, clinical and quality of life endpoints will be monitored. Fecal samples will be collected to assess pH, short-chain fatty acid concentrations, bacterial abundance and diversity. . Randomized, open label, n=102
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
Jan 2017 Chronic Inflammatory Disease, Lifestyle and Treatment Response (BELIEVE) Observational University of Southern Denmark Chronic inflammatory diseases (CID) - including inflammatory bowel diseases (Crohn's disease and ulcerative colitis), rheumatic conditions (rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis), inflammatory skin diseases (psoriasis, hidradenitis suppurativa) and non-infectious uveitis are treated with biologics targeting the pro-inflammatory molecule tumour necrosis factor-α (TNF), i.e. TNF inhibitors. Up to one third of the patients do, however, not respond to biologics and lifestyle is assumed to affect the treatment outcome. However, little is known on the effects of lifestyle as a prognostic factor (possibly enabling personalised medicine). The aims of this multidisciplinary collaboration are to identify lifestyle factors that support individualised forecasting of optimised treatment outcome on these costly drugs. This prospective cohort study will enrol CID patients assigned for biologic treatment. At baseline (Pre-treatment), patient characteristics are assessed using patient-reported outcome measures and clinical assessments on disease activity, quality of life, and lifestyle together with registry data on comorbidity and medication. Follow-up will be conducted at week 14-16 after treatment initiation (according to the current Danish standards). Evaluation of a successful treatment outcome response will - for each disease - be based on most frequently used primary endpoints; the major outcome of the analyses will be to detect differences in treatment outcome between patients with specific lifestyle characteristics. The overarching goal of this project is to improve the lives of patients suffering from CID, by providing evidence to support dietary recommendations likely to improve the clinical outcome. Prospective 16 weeks, observational prospective cohort n=320
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
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
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
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

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