RECRUITINGINTERVENTIONAL
Diet Intervention Treatment for Active Ulcerative Colitis
Diet Intervention as a Prebiotic Treatment for Active Ulcerative Colitis
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- • Females and Males between the ages of 18 - 75 years of age at the time of enrolment
- Must have established diagnosis of UC by standard endoscopic, radiographic, or histological criteria
- Must have active UC defined by having a Mayo score equal to or greater than 2 within two months prior to enrollment
- Must have had \> 10cm involvement at some point in their disease history
- FCP\>250 or active endo within 6 months
- If a smoker, must not change smoking habits (frequency) during the course of the study
- If receiving medical therapy, no baseline therapy change within 4 weeks of study initiation and no change during the course of the study
Who Should NOT Join This Trial:
- • Uncontrolled inflammation which will likely require surgery or escalation of therapy within 4 weeks of enrollment
- Pregnant or lactating females
- Allergy or intolerance to key or a great number food components of the study diet
- Current NSAID use
- Diagnosed with PSC
- Using topical therapies or suppositories
- Antibiotic use within 4 weeks of the study enrollment or during the study
- Confirmed C. difficile infection within 3 months of recruitment;
- Diagnosis of primary PSC;
- Currently using topical therapies or suppositories
- History of dysplasia or colorectal neoplasia.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* • Females and Males between the ages of 18 - 75 years of age at the time of enrolment
* Must have established diagnosis of UC by standard endoscopic, radiographic, or histological criteria
* Must have active UC defined by having a Mayo score equal to or greater than 2 within two months prior to enrollment
* Must have had \> 10cm involvement at some point in their disease history
* FCP\>250 or active endo within 6 months
* If a smoker, must not change smoking habits (frequency) during the course of the study
* If receiving medical therapy, no baseline therapy change within 4 weeks of study initiation and no change during the course of the study
Exclusion Criteria:
* • Uncontrolled inflammation which will likely require surgery or escalation of therapy within 4 weeks of enrollment
* Pregnant or lactating females
* Allergy or intolerance to key or a great number food components of the study diet
* Current NSAID use
* Diagnosed with PSC
* Using topical therapies or suppositories
* Antibiotic use within 4 weeks of the study enrollment or during the study
* Confirmed C. difficile infection within 3 months of recruitment;
* Diagnosis of primary PSC;
* Currently using topical therapies or suppositories
* History of dysplasia or colorectal neoplasia.
Treatments Being Tested
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.
Locations (1)
Mount Sinai Hospital
Toronto, Ontario, Canada