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UC intervention diet for Ulcerative Colitis
N/A
Recruiting
Research Sponsored by Mount Sinai Hospital, Canada
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks
Awards & highlights
Study Summary
This trial will test whether a special diet can help treat ulcerative colitis by changing the microbiome.
Eligible Conditions
- Ulcerative Colitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in microbiome composition
Change in microbiome function
Secondary outcome measures
Decrease in clinical disease activity
Decrease in endoscopic disease activity
Trial Design
1Treatment groups
Experimental Treatment
Group I: Ulcerative colitis patients with mild to moderate activityExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,377 Previous Clinical Trials
4,315,791 Total Patients Enrolled
14 Trials studying Ulcerative Colitis
2,152 Patients Enrolled for Ulcerative Colitis
Mount Sinai Hospital, CanadaLead Sponsor
196 Previous Clinical Trials
67,588 Total Patients Enrolled
8 Trials studying Ulcerative Colitis
1,419 Patients Enrolled for Ulcerative Colitis
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are between the ages of 18 and 75 years of age at the time of enrolment.Your disease has affected an area larger than 10 centimeters at some point in the past.You have allergies or sensitivities to many of the foods in the study diet.You have severe inflammation that may require surgery or stronger treatment within 4 weeks of joining the study.You are currently taking nonsteroidal anti-inflammatory drugs (NSAIDs).You are currently using creams, ointments, or suppositories for treatment.You are currently using creams or suppositories on your skin or inside your body.You have a history of abnormal cell growth or tumors in your colon or rectum.
Research Study Groups:
This trial has the following groups:- Group 1: Ulcerative colitis patients with mild to moderate activity
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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