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Mediterranean Diet for Inflammatory Bowel Disease
N/A
Recruiting
Research Sponsored by University of California, San Diego
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 42 days
Awards & highlights
Study Summary
This trial will study how changing your diet can affect inflammatory bowel disease. Blood & stool samples will be taken before & after diet changes & analyzed. Disease severity will be compared by measuring inflammation markers.
Who is the study for?
This trial is for adults over 18 with mild to moderate Crohn's Disease, as indicated by specific disease activity and inflammation markers. Participants must not have started or changed their standard treatment recently, be on stable medication doses, and free from certain infections or antibiotic use.Check my eligibility
What is being tested?
The study explores how a Mediterranean Diet affects individuals with Inflammatory Bowel Disease (IBD). It involves analyzing blood and stool samples before and after dietary changes to assess the impact on microbiome composition and inflammation levels in patients.See study design
What are the potential side effects?
While the trial focuses on diet rather than medication, potential side effects may include digestive discomfort as the body adjusts to new eating habits. Allergic reactions are possible if participants are sensitive to any components of the Mediterranean Diet.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 42 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~42 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
short Crohn's Disease Activity Index (sCDAI)
Side effects data
From 2022 Phase 1 & 2 trial • 33 Patients • NCT0453473810%
Dental infection
10%
Deep vein thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Usual Care
Mediterranean Diet
Trial Design
1Treatment groups
Experimental Treatment
Group I: Mediterranean DietExperimental Treatment1 Intervention
Mediterranean Diet for 42 Days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mediterranean Diet
2013
Completed Phase 4
~2350
Find a Location
Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,122 Previous Clinical Trials
1,520,954 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I started or changed my standard cancer treatment dose within the last 3 months.My medication doses, like steroids, have been stable.I am currently taking antibiotics.I had a C. difficile infection within the last month.I have mild to moderate Crohn's Disease with specific test results.
Research Study Groups:
This trial has the following groups:- Group 1: Mediterranean Diet
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many patients are currently taking part in this research project?
"Affirmative. The information hosted on clinicaltrials.gov affirms that this medical trial is recruiting participants, with the original posting occurring on September 1st 2023. This ongoing recruitment seeks 90 patients from one site and was last updated August 28th 2023."
Answered by AI
Are there any open vacancies for patients in this clinical research endeavor?
"According to records on clinicaltrials.gov, this ongoing investigation is in need of participants. The trial was first announced on September 1st 2023 and the most recent update occured at the end of August, 2023."
Answered by AI
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