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Diet Study for Crohn's Disease

This study is looking at how a special diet, called the Catered Anti-Inflammatory Diet, affects people with Crohn's disease (CD). This diet is designed to be anti-inflammatory, with specific amounts of fiber and fats, and excludes certain foods like red meat. You might be able to join if you are 16-75 years old and have been diagnosed with mild to moderately active Crohn's disease, meaning your Crohn's Disease Activity Index (CDAI) is between 150-250 and you have signs of inflammation like a fecal calprotectin (a marker of inflammation in your stool) level above 150mg/dl. The study will compare this special diet to your usual diet, with guidance from a dietitian. Researchers will measure if your Crohn's symptoms improve and if inflammation in your body goes down.

Study design
This study plans to enroll 122 participants. It is an interventional study, meaning participants will receive a specific intervention (either the special diet or diet guidance for their usual diet).
What's involved
If you are in the Catered Anti-Inflammatory Diet group, you will receive fully catered meals for 8 weeks, delivered twice weekly. If you are in the Usual Diet group, you will receive weekly remote sessions with a registered dietitian for 8 weeks.
Compensation
Not stated in the trial record.
Follow-up
Researchers will check your Crohn's Disease Activity Index (CDAI) and fecal calprotectin levels at baseline, week 8, week 10, and week 18.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07671872

Tailored Anti-Inflammatory American Diet for Patients With Crohn's Disease

Not Yet Recruiting
NAAges 16–75InterventionalTreatment
University of Miami
~122 participants
Updated 2026-06-26 on ClinicalTrials.gov
What's tested:Catered Anti-Inflammatory DietDiet Guidance for Usual Diet

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response
Measured over Baseline, Week 8, Week 10, Week 18
+1 more outcome measured

Conditions

Crohn's Disease, Active
Crohn's Disease (CD)
Diet Interventions

Explore related trials

Crohn Disease

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Oriana M Damas, MD, MSCTI · PRINCIPAL_INVESTIGATOR · University of Miami

Who to contact

Eytan I Stern, MS, RD, LD/N, CNSC
[email protected]
305-243-6405
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Documented diagnosis with Crohn's Disease from medical records.
Ages 16-75
Mild to moderately active CD disease, defined by one of the following criteria:
On stable medications for their disease as or 3 months if medication is not listed

Exclusion

Diagnosis of Ulcerative Colitis (UC).
Prior J pouch or diversion
Recent inflammatory bowel disease (IBD) related hospitalizations in the last 4 weeks
Clostridium difficile or enteric infections in the last 4 weeks
Use of probiotics in the last 4 weeks
Patients following the specific carbohydrate diet or Mediterranean diet or anti-inflammatory diet
Active cancer or conditions limiting their ability to follow a diet (heart failure, end stage renal disease)
Pregnancy, breastfeeding or planning to become pregnant during study period
Use of Total Parenteral Nutrition at the time of screening and during the study period
Other significant or life-threatening co-morbidities
The need for antibiotic use during the study period
Adults unable to consent
Ages \< 16 and \> 75 years old
Prisoners
Crohn's specific complicated disease including active Stenotic (stricturing, B2) disease within the past 12 months, or Internal penetrating (B3) disease, or Draining perianal fistula, or Prior bowel resection
Patients with concomitant Celiac disease

What this trial measures

  • Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical ResponseBaseline, Week 8, Week 10, Week 18

    Clinical response is defined as a ≥70-point reduction from baseline in the Crohn's Disease Activity Index (CDAI). The outcome is the percentage of participants who achieve this response following the dietary intervention.

  • Participants Achieving Fecal Calprotectin (FC) ReductionBaseline, Week 8, Week 10, Week 18

    Reduction is defined as a \>50% decrease from baseline in fecal calprotectin (FC). The outcome is the percentage of participants who achieve this reduction.