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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
No Placebo-Only Group

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.
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.
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 weeks
Treatment ~ Varies
Follow Up ~42 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 42 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
short Crohn's Disease Activity Index (sCDAI)

Side effects data

From 2022 Phase 1 & 2 trial • 33 Patients • NCT04534738
4%
Shortness of breath
4%
Cellulitis of the chest wall
4%
Fainting
4%
Pneumonia
4%
Bacteremia
4%
Neutropenic fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Mediterranean Diet
Usual Care

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~2550

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,180 Previous Clinical Trials
1,574,957 Total Patients Enrolled

Media Library

Mediterranean Diet (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05973500 — N/A
Inflammatory Bowel Disease Research Study Groups: Mediterranean Diet
Inflammatory Bowel Disease Clinical Trial 2023: Mediterranean Diet Highlights & Side Effects. Trial Name: NCT05973500 — N/A
Mediterranean Diet (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05973500 — N/A
~60 spots leftby Aug 2028
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