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Anti-inflammatory Diet for Crohn's Disease (CD Trial)
N/A
Recruiting
Led By Zhaoping Li, MD, PhD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
History of Crohn's Disease (CD) with mild to moderate symptoms and prior biopsy proof
Age of 18 to 75 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
CD Trial Summary
This trial will study how an anti-inflammatory diet affects patients with inflammatory bowel disease.
Who is the study for?
This trial is for adults aged 18-75 with mild to moderate Crohn's Disease, confirmed by a previous biopsy. Participants should not have severe other conditions like heart or liver disease, recent hospitalizations, substance abuse issues, or be pregnant. They must be willing to stop taking probiotics and certain medications without changing their dosage during the study.Check my eligibility
What is being tested?
The study compares the effects of an anti-inflammatory diet versus a regular diet on patients with Crohn's Disease. It aims to see if the special diet can positively change gut bacteria diversity and function, which could provide insights into how diet affects this condition.See study design
What are the potential side effects?
While specific side effects are not listed for dietary interventions, participants may experience changes in digestion or new food sensitivities as they adjust to the anti-inflammatory diet compared to their regular eating habits.
CD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have mild to moderate Crohn's Disease confirmed by a biopsy.
Select...
I am between 18 and 75 years old.
CD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy of the anti-inflammatory whole food diet for the induction of remission in Crohn's Disease
Side effects data
From 2015 Phase 3 trial • 300 Patients • NCT0160631963%
Acute uri
61%
Fever
26%
Allergic rhinitis
25%
Otitis media NOS
21%
Cough
11%
Strep sore throat
11%
Vomiting
9%
Headache
7%
Diarrhea
7%
Wheezing
3%
asthma exacerbation
1%
Pneumonia
1%
Simple laceration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Acetaminophen
Ibuprofen
CD Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Anti-inflammatory whole foodExperimental Treatment1 Intervention
Included food items will include a defined minimum diversity of fruits, vegetables, and nuts based on complementary phytonutrient contents, particularly those rich in phenolic compounds such as ellagitannins and sulforaphanes. Selected herbs (e.g., curcumin), fermented foods, fats (e.g., avocado), and oils (e.g., olive oil) will be permitted or encouraged. Recommended portions of complex carbohydrates (50% - 60%) and lean proteins (20% - 30%) will form the basis of weight-based caloric needs. The goal is to have 5 servings of vegetables, 2 fruits per day, and 5 vegetable color groups per week. Vegetables with high insoluble fiber content will be cooked instead of eaten raw.
Group II: Regular DietActive Control1 Intervention
Patients in the control diet arm will be counseled to continue their regular diets and focus on recording all food intake.
Find a Location
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,530 Previous Clinical Trials
10,264,592 Total Patients Enrolled
Zhaoping Li, MD, PhD4.76 ReviewsPrincipal Investigator - University of California, Los Angeles
Medical School - University of Illinois, Chicago
18 Previous Clinical Trials
694 Total Patients Enrolled
5Patient Review
Good
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with or have a history of anorexia.I have had surgery on my digestive system in the past.I have or had kidney disease.I have or had liver disease.I have or had lung disease.I have had heart surgery in the past or currently.I have a history of heart disease.I have or had an end enterostomy.I have or had an endocrine disorder.I have high blood pressure that hasn't been treated.I urgently need surgery in my abdomen.I have a history of bleeding disorders.I am severely malnourished.I have or had cancer.I have a history of seizures or currently experience them.I have a history of or currently experience chronic diarrhea.I have mild to moderate Crohn's Disease confirmed by a biopsy.I have had a stroke or have been diagnosed with an irregular heartbeat.I am between 18 and 75 years old.I am not changing my doses of immunosuppressants or similar drugs during the trial, except to reduce corticosteroids.
Research Study Groups:
This trial has the following groups:- Group 1: Regular Diet
- Group 2: Anti-inflammatory whole food
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 enrollees have joined this research study?
"Affirmative, data published on clinicaltrials.gov reveals that recruitment for this medical study is ongoing since its first posting date of October 5th 2020. The latest updates were made on November 9th 2021 and 116 participants need to be enrolled at one site."
Answered by AI
Does this research accept elderly participants?
"The eligibility requirements for this trial necessitate that qualified applicants are between 18 and 75 years old. For those below the age of consent, there are 90 unique trials available; for seniors over 65-years-old, 266 clinical studies can be accessed."
Answered by AI
Is recruitment for this research endeavor currently ongoing?
"The records found on clinicaltrials.gov indicate that this investigation is still enrolling participants. It was first announced in October 5th 2020 and the most recent update occurred November 9 2021."
Answered by AI
Would I be eligible to join this research experiment?
"Eligible participants must possess inflammatory bowel diseases, and be between 18 to 75 years of age. This medical study is seeking approximately 116 test subjects."
Answered by AI
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