122 Participants NeededMy employer runs this trial

Anti-Inflammatory Diet for Crohn's Disease

EI
Overseen ByEytan I Stern, MS, RD, LD/N, CNSC
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: University of Miami
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special anti-inflammatory diet to determine its effectiveness in improving symptoms and reducing inflammation in people with Crohn's Disease. Participants will alternate between a catered anti-inflammatory diet and diet guidance to assess the diet's effects. It is suitable for those diagnosed with Crohn's Disease who have mild to moderate symptoms and are on stable medication. As an unphased trial, this study provides a unique opportunity to explore dietary impacts on Crohn's Disease.

What prior data suggests that this anti-inflammatory diet is safe for Crohn's Disease patients?

A previous study found an anti-inflammatory diet to be safe for people. This diet includes foods that help reduce inflammation, which links to many health issues. Since this trial focuses on dietary changes, it is generally considered safe, as it doesn't involve new drugs or medical devices. Participants usually find such diets easy to follow, and they tend to have fewer side effects than other treatments. However, some individuals might experience mild side effects, such as changes in digestion. Adhering to the diet guidelines is important to avoid any issues.12345

Why are researchers excited about this trial?

Researchers are excited about the catered anti-inflammatory diet for Crohn's disease because it offers a non-pharmaceutical approach to managing symptoms. Unlike standard treatments like corticosteroids or immunosuppressants, which often come with significant side effects, this diet aims to reduce inflammation through food choices. Participants receive personalized meals that are specifically designed to minimize inflammatory responses, potentially offering a gentler way to manage the condition. Additionally, by combining the catered diet with nutritional guidance, this approach emphasizes long-term lifestyle changes that could sustain symptom relief beyond the treatment period.

What evidence suggests that this anti-inflammatory diet is effective for Crohn's Disease?

Research has shown that an anti-inflammatory diet might ease Crohn's disease symptoms by reducing inflammation in the digestive system. Some studies have found that dietary changes can improve symptoms and gut health. In this trial, participants will follow one of two sequences: one group will start with an 8-week catered anti-inflammatory diet followed by diet guidance, while the other group will begin with diet guidance followed by the catered anti-inflammatory diet. Foods that lower inflammation could help manage Crohn's by calming the body's inflammatory response. Early results suggest that individuals on these diets experience fewer flare-ups and feel better overall. However, more research is needed to confirm these effects specifically for Crohn's disease.678910

Who Is on the Research Team?

OM

Oriana M Damas, MD, MSCTI

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for people diagnosed with Crohn's Disease. Participants should be able to follow a specific diet and attend counseling sessions. Those with other major health issues or who can't stick to the study plan may not be eligible.

Inclusion Criteria

I have been on the same medication for my condition for at least 3 months.
My Crohn's disease is mild to moderate and currently active.
I have a confirmed diagnosis of Crohn's Disease.
See 1 more

Exclusion Criteria

I have been hospitalized for inflammatory bowel disease in the past 4 weeks.
I have had a J pouch surgery or a bowel diversion.
I have taken probiotics in the past 4 weeks.
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Catered Anti-Inflammatory Diet

Participants receive an 8-week catered anti-inflammatory diet intervention

8 weeks
Weekly counseling sessions

Washout

Participants undergo a 2-week washout period

2 weeks

Diet Guidance

Participants receive an 8-week diet guidance period with weekly counseling while consuming their usual diet

8 weeks
Weekly counseling sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Catered Anti-Inflammatory Diet

Trial Overview

The study compares a specially prepared anti-inflammatory diet designed for Americans with Crohn's Disease against standard dietary advice, to see which helps more with symptoms and inflammation.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Sequence B→A: Diet Guidance Followed by Catered Anti-Inflammatory Diet GroupExperimental Treatment2 Interventions
Group II: Sequence A→B: Catered Anti-Inflammatory Diet Followed by Diet Guidance GroupExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials
976
Recruited
423,000+

United States Department of Defense

Collaborator

Trials
940
Recruited
339,000+

Citations

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Learn about this long-term condition that causes inflammation in the digestive tract, including symptoms, causes and treatment options.

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crohnscolitisfoundation.org

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Crohn's & Colitis Foundation: Homepage

We are a non-profit, volunteer-fueled organization dedicated to finding cures for Crohn's disease and ulcerative colitis, and improving the quality of life ...

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Infliximab for the treatment of fistulas in patients with ...

Results: Sixty-eight percent of the patients who received 5 mg of infliximab per kilogram and 56 percent of those who received 10 mg per kilogram achieved the ...

Mayo Clinic Explains Crohn's Disease

Let our experts walk you through the facts, the questions, and the answers to help you better understand this condition. Treatment options for ...

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