Mount Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
Location status: Recruiting
NCT Number: NCT04121806
The purpose of this study is to determine if a sustainable non-elemental diet can be used as a probiotic tool to alter the dysbiotic microbiome found in individuals with ulcerative colitis and thereby decrease disease activity.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Toronto, Ontario, M5G 1X5, Canada
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 10 weeks
measured by 16S rDNA sequencing and comparing pretreatment diet and the treatment diet within an individual
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
Time frame: 10 weeks
measured by a decrease in Mayo score between pretreatment diet and the treatment diet within an individual
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
Contact information is provided by the study sponsor or research team.
Mount Sinai Hospital, Canada
Other
Diet Intervention as a Prebiotic Treatment for Active Ulcerative Colitis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07012395
Colitis, Colitis, Ulcerative
Canoga Park, California, United States
View Trial DetailsNCT05076175
Colitis, Colitis, Ulcerative
Phoenix, Arizona, United States
View Trial DetailsNCT07483073
Colitis, Colitis, Ulcerative
Scottsdale, Arizona, United States
View Trial DetailsNCT07296315
Colitis, Colitis, Ulcerative
Miami, Florida, United States
View Trial Details