CDED
Prospective Dietary Therapy Using Crohn's Disease Exclusion Diet for Ileal Pouch Anal Anastomosis Patients
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.
Sponsor: Tel-Aviv Sourasky Medical Center
Trial Type: Interventional
First Posted: March 31, 2020
CDED
The Challenge Study: A Dietary Personalization Protocol for Patients With Crohn's Disease and Deep Remission
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
Sponsor: Wolfson Medical Center
Trial Type: Interventional
First Posted: Oct. 12, 2016
CDED,
EEN,
PEN
Diet for Induction and Maintenance of Remission and Re-biosis in Crohn's Disease (DIETOMICS-CD)
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
Sponsor: Prof. Arie Levine
Trial Type: Interventional
First Posted: July 25, 2016
CDED
Crohn Disease Exclusion Diet After Single Medication De-escalation (CEASE)
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
Sponsor: Children's Hospital of Philadelphia
Trial Type: Interventional | Completed
First Posted: June 15, 2015
CDED
Pilot Study of Partial Enteral Nutrition With a Unique Diet for the Treatment of Adult Patients With Crohn's Disease (CDED-ADULTS)
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
Sponsor: Prof. Arie Levine
Trial Type: Interventional
First Posted: Sept. 4, 2014
