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
Date Title Trial type Completed Diets Sponsor Summary Excerpt Trial
Jul 2016 Abnormal Fecal Microbiota in Healthy Subjects at High Risk for Crohn's Disease (MAGIC) Observational University Hospital, Lille Transversal multicentric French study on the microbiota in patients with Crohn's disease and their first degree healthy relatives The primary objective is the comparison of microbiota between patients with CD, healthy controls non genetically linked and first degree healthy relatives of patients with CD. The primary objective is the comparison of microbiota between patients with CD, healthy controls non genetically linked and first degree healthy relatives of patients with CD. The first endpoint is the Lachnospiraceae rates in each group. The secondary objectives are: 1. The search for an association between bacterial dysbiosis and different genetic backgrounds in patients with CD, their first degree healthy relatives and controls. 2. The quantification of potential invasive bacteria with invasive properties (E. coli including adherent-invasive E. coli, Shigella, Salmonella, Yersinia, Campylobacter), and fecal fungal flora (Candida albicans, in particular) and their association with genetic and serological profiles in patients with CD, their healthy relatives and control subjects. 3. A study of environmental risk factors using a questionnaire to be submitted to CD patients, their healthy relatives and control subjects. Observational n= 240.
Jan 2020 Adjunctive Treatment With Vitamin D3 in Patients With Active IBD (ACTIVATED) Interventional Massachusetts General Hospital Besides its traditional role in bone homeostasis, several studies have recognized the important role Vitamin D plays in modulating the immune response, cancer, and cardiovascular disease. Specifically, Vitamin D may mediate immunity by modulating autophagy in leukocytes and regulating the gut microbiome. Thus, Vitamin D may play an important role in IBD. Furthermore, evidence suggests that the effect of vitamin D may be mediated through the TNF-α pathway, suggesting a synergy with anti-TNF therapy. This is a randomized, double blind, placebo-controlled trial to study the effect of Vitamin D3 as an adjunct therapy for patients with active CD, UC, or IBD unspecified who are undergoing anti-TNF induction therapy.
Jan 2015 Bacteria & Inflammation in the Gut (BIG) Study (BIG) Observational EEN NHS Greater Glasgow and Clyde EEN has previously been shown to induce changes in major bacterial metabolites and dominant bacterial species which are more profound in children that clinically improve. This study aims to determine whether it is possible to maintain these bacterial changes with prolonged supplementary enteral nutrition (SEN) while returning to normal diet and if this can reduce risk of subsequent relapse for children with CD. Observational, case control, n=200
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.
Mar 2018 Chronic Inflammatory Disease, Lifestyle and Risk of Disease (PROCID-DHC) Interventional University of Southern Denmark The study will use data from all of the 57,053 participants in the Danish cohort "Diet, Health and Cancer (DHC)" together with registry data. Blood samples, anthropometric measures and questionnaire data on diet and lifestyle were collected at the DHC study entry. The National Patient Registry (NPR) will be used to obtain to identify patients with CID during follow-up. Follow-up information on death and immigration will be collected in March 2018 from the Danish Civil Registration Register. The outcome of Chronic Inflammaroty Diseases (CID) is defined as at least one of the following CIDs: Crohn's disease, ulcerative colitis, psoriasis/psoriatic arthritis, rheumatoid arthritis/ankylosing arthritis, or multiple sclerosis, during the follow-up period from 1993 to March 2018. The primary hypothesis is that "the risk of CID will be significantly higher among those with a low fibre/high red and processed meat intake compared to those with a high fibre/low red and processed meat intake." Based on previous research on a shared etiology in CIDs a second hypothesis is that "the postulated causality between low fibre/high red and processed meat intake and risk of developing CID is applicable for each of the CID-diagnoses." Observational, prospective, 24 years, n=57,053
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
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
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.
Jun 2015 Crohn Disease Exclusion Diet After Single Medication De-escalation (CEASE) Interventional CDED Children's Hospital of Philadelphia Diet has been proven to impact disease activity in CD and may allow for sustained drug-free remission. The primary objective of this study is to determine whether pediatric CD patients in long-standing remission remain in remission longer after stopping medications if they follow the Crohn's Disease Exclusion Diet (CDED). The hypothesis is that subjects on the CDED will have longer time-to-relapse as opposed to those on an unrestricted diet. n=35
Jul 2014 Cyclic Exclusive Enteral Nutrition as Maintenance Therapy for Pediatric Crohn’s Disease (CD-HOPE) Interventional EEN Assistance Publique - Hôpitaux de Paris There is convincing data indicating that EN is highly efficacious when given on an exclusive basis, while the use of partial EN is markedly less effective to induce remission in active Crohn's disease as compared to exclusive EN. Recently, it was suggested that exclusive EN has a dominant effect on the intestinal microbiota, which contributes to the induction of remission. There exists several strategies to maintain remission in children with CD, but there is no clear consensus on which maintenance treatment to follow. There are some indicators to believe that enteral nutritional therapy might play also a significant role as maintenance therapy for CD. Given the fact that many centers use a top-down approach with the introduction of immunosuppressors and/or biologics at/or shortly after diagnosis, the investigators wanted to test the possibility of a treatment option to efficiently maintain remission with less (or no) side effects based on enteral nutrition to avoid the early use of immunosuppressors.
Feb 2015 Decentralized Dietary UC Pilot Trial Interventional Transparency Life Sciences This study is designed to assess differences in remote and on-site patient study participation in the State of Massachusetts, as well as the significance of dietary interventions (Combined Anti-inflammatory Diet (CAID) and their impact on UC. The study will activate one site with a Principal Investigator who will utilize each subject's local care system (local Gastroenterologist) to collect study data, along with telemonitoring and video visits, to make key study assessments and decisions regarding subjects' progression in the study. Randomized, doiuble blind, n=51
Feb 2020 Decoding Personalized Nutritional, Microbiome and Host Patterns Impacting Clinical and Prognostic Features in Crohn's Disease Observational Weizmann Institute of Science The study is 3 arms observational study with no intervention that aims to understand the link between Crohn's disease, microbiome and diet in children. 150 children newly diagnosed with Crohn's disease will participate in the study and their data will be used to create an algorithm about their microbiome, disease, diet, etc. 100 other children newly diagnosed will participate in the study and their data will be use to validate the algorithm. The investigators will be recruiting 50 healthy participants: 20 that are undergoing an endoscopy for abdominal pain and 30 that comes to the physician for different reasons.