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New treatment option for Colitis, Ulcerative
Official title Diet Intervention Treatment for Active Ulcerative Colitis
ClinicalTrials.gov ID: NCT04121806
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.