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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
Mount Sinai Hospital
Toronto, Ontario, Canada
RECRUITINGChange in microbiome composition
measured by 16S rDNA sequencing and comparing pretreatment diet and the treatment diet within an individual
Time frame: 10 weeks
Change in microbiome function
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
Decrease in endoscopic disease activity
measured by a decrease in Mayo score between pretreatment diet and the treatment diet within an individual
Time frame: 10 weeks
Decrease in clinical disease activity
measured by a decrease in serum C-reactive protein (CRP) levels between pretreatment diet and the treatment diet within an individual
Time frame: 10 weeks
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