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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

Must not have

History or current diagnosis of anorexia

History or current diagnosis of previous gastrointestinal surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have mild to moderate Crohn's Disease confirmed by a biopsy.

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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with or have a history of anorexia.

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I have had surgery on my digestive system in the past.

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I have or had kidney disease.

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I have or had liver disease.

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I have or had lung disease.

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I have had heart surgery in the past or currently.

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I have a history of heart disease.

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I have or had an end enterostomy.

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I have or had an endocrine disorder.

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I have high blood pressure that hasn't been treated.

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I urgently need surgery in my abdomen.

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I have a history of bleeding disorders.

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I am severely malnourished.

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I have or had cancer.

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I have a history of seizures or currently experience them.

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I have a history of or currently experience chronic diarrhea.

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I have had a stroke or have been diagnosed with an irregular heartbeat.

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I am not changing my doses of immunosuppressants or similar drugs during the trial, except to reduce corticosteroids.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

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 • NCT01606319

63%

Acute uri

61%

Fever

26%

Allergic rhinitis

25%

Otitis media NOS

21%

Cough

11%

Strep sore throat

11%

Vomiting

Headache

Diarrhea

Wheezing

asthma exacerbation

Pneumonia

Simple laceration

100%

80%

60%

40%

20%

Study treatment Arm

Acetaminophen

Ibuprofen

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.

0 / 20Eligibility criteria met