Diet Intervention Treatment for Active Ulcerative Colitis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04121806|
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : May 13, 2021
|Condition or disease||Intervention/treatment||Phase|
|Colitis, Ulcerative||Other: UC intervention diet||Not Applicable|
The etiology of inflammatory bowel disease (IBD), including ulcerative colitis (UC), is complex and poorly understood, but the current hypothesis is that IBD arises from an aberrant immune response to commensal bacteria in a genetically susceptible host, and is triggered by environmental factors. Environmental factors such as the microbiome and diet, play a significant role in the risk of IBD. Diet has been identified as one of the main drivers of the microbiome composition and the microbiome and diet can work in tandem to affect host physiology.
In spite of patient interest in diet and numerous diet studies, currently there is no diet that is clinically validated or universally agreed upon for adult IBD patients. We also lack rigorous studies to show how the microbiome is influenced by diet and affects patient outcomes.
We propose to use a sustainable non-elemental diet aimed at altering the microbiome in patients with mild to moderately active UC to alter their disease activity.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Diet Intervention as a Prebiotic Treatment for Active Ulcerative Colitis|
|Actual Study Start Date :||March 1, 2021|
|Estimated Primary Completion Date :||September 30, 2022|
|Estimated Study Completion Date :||September 30, 2022|
Experimental: Ulcerative colitis patients with mild to moderate activity
Participants will be followed for 14 days on their traditional diet followed by an 8 week intervention with the specially designed and provided treatment diet.
Other: UC intervention diet
The treatment diet has been designed based on the literature with the goal of influencing the biodiversity and density of the microbiome. All food through the duration of the 8 week dietary intervention period of the study will be provided to the treatment arm study participants.
- Change in microbiome composition [ Time Frame: 10 weeks ]measured by 16S rDNA sequencing and comparing pretreatment diet and the treatment diet within an individual
- Change in microbiome function [ Time Frame: 10 weeks ]measured by shotgun sequencing and comparing difference in enriched functional pathways between pretreatment diet and the treatment diet within an individual
- Decrease in endoscopic disease activity [ Time Frame: 10 weeks ]measured by a decrease in Mayo score between pretreatment diet and the treatment diet within an individual
- Decrease in clinical disease activity [ Time Frame: 10 weeks ]measured by a decrease in serum C-reactive protein (CRP) levels between pretreatment diet and the treatment diet within an individual
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04121806
|Contact: Klaudia Rymaszewski||4165864800 ext firstname.lastname@example.org|
|Mount Sinai Hospital||Recruiting|
|Toronto, Ontario, Canada, M5G 1X5|
|Contact: Klaudia Rymaszewski 4165864800 ext 2318 email@example.com|
|Principal Investigator: Mark S Silverberg, MD|