Taking people in United StatesNo phase

Anti-Inflammatory Diet Tailored for People With Active Crohn's Disease

Tests a tailored anti-inflammatory diet in people with active Crohn's disease.

Key facts

Who runs it: University of Miami
Where: Miami, United StatesSee the site
Trial code: NCT07671872
Registry title: Tailored Anti-Inflammatory American Diet for Patients With Crohn's Disease
Status: Recruiting
People taking part: 122 people, planned
Started: 16 Sept 2026
Expected to end: Aug 2030
Type of study: Interventional, 2 groups
Treatments tested: Catered Anti-Inflammatory Diet
Diet Guidance for Usual Diet
Record updated: 24 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people aged 16 to 75 with mild to moderately active Crohn's disease who take stable medicines. It tests an anti-inflammatory diet made for people living in the United States.

Age: 16 to 75 years
Sex: All sexes can join.
Disease stage: Crohn's disease with mild to moderate activity (CDAI 150-250), plus active inflammation shown by fecal calprotectin >150mg/dl, by imaging, or by endoscopy within 4 weeks of baseline.
Earlier treatment: Must be on stable medicines for the disease for 3 months. No probiotics in the last 4 weeks. Must not already follow the specific carbohydrate diet, Mediterranean diet or an anti-inflammatory diet.
Biomarker or test result: Fecal calprotectin >150mg/dl, or imaging or endoscopy findings of active ileal and/or colonic disease.

Main reasons for not taking part

Ulcerative colitis, J pouch or diversion
IBD-related hospital stay, C. difficile or gut infection in the last 4 weeks
Active stricturing (B2) disease in the last 12 months, internal penetrating (B3) disease, draining perianal fistula or prior bowel resection
Pregnancy, breastfeeding or planning pregnancy during the study
Celiac disease, active cancer, total parenteral nutrition, or other serious illness

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

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:; Crohn's disease activity index (CDAI) 150-250 (mild-to-moderate only active disease) AND presence of active inflammation either by: fecal calprotectin >150mg/dl. or radiologic findings of active ileal and/or colonic disease, or endoscopic findings showing active ileal and/or colonic disease within 4 weeks of baseline; -On stable medications for their disease as or 3 months if medication is not listed

Who cannot take part

Prior J pouch or diversion
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
Recent inflammatory bowel disease (IBD) related hospitalizations in the last 4 weeks
Clostridium difficile or enteric infections in the last 4 weeks
Active cancer or conditions limiting their ability to follow a diet (heart failure, end stage renal disease)
Ages < 16 and > 75 years old
Diagnosis of Ulcerative Colitis (UC)
Use of probiotics in the last 4 weeks
Patients following the specific carbohydrate diet or Mediterranean diet or anti-inflammatory diet
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
Prisoners

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 16 and 75 years old?

Where in United States

University of MiamiMiami, United StatesContact: Eytan I Stern, MS, RD, LD/N, CNSCTaking people

About the trial

What the trial wants to find out

The purpose of this study is to test the effect of an anti-inflammatory diet tailored for patients living in the United States with Crohn's Disease (CD) on clinical symptoms and disease inflammation and to identify biomarkers of response to dietary therapy.

The 2 groups in the trial

Sequence A→B: Catered Anti-Inflammatory Diet Followed by Diet Guidance GroupTreatment being tested
Participants in this group will first receive an 8-week catered anti-inflammatory diet intervention, followed by a 2-week washout period, then an 8-week diet guidance period in which they consume their usual diet with weekly counseling focused on safe food preparation.
Treatment: Catered Anti-Inflammatory Diet and Diet Guidance for Usual Diet
Sequence B→A: Diet Guidance Followed by Catered Anti-Inflammatory Diet GroupTreatment being tested
Participants in this group will first receive an 8-week diet guidance period with weekly counseling while consuming their usual diet, followed by a 2-week washout period, then an 8-week catered anti-inflammatory diet intervention.
Treatment: Catered Anti-Inflammatory Diet and Diet Guidance for Usual Diet