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

Targeting Gut Inflammation Through Diet: a Tailored American Diet for Patients With Crohn's Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
16 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a diet designed to reduce inflammation in people in the United States with Crohn’s disease. It is for people ages 16–75 with mild to moderate active disease. Researchers will study symptoms, inflammation, and body markers that may show who responds to the diet.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You have Crohn’s disease confirmed in your medical records.
  • You are 16–75 years old.
  • Your Crohn’s disease activity score (CDAI) is 150–250, showing mild to moderate active disease.
  • You have active inflammation shown by a stool calprotectin test above 150 mg/dl, imaging, or a scope exam. Imaging or scope exams must show disease in the small bowel’s last section or the colon within 4 weeks of the study’s start.
  • Your Crohn’s medicines are stable. The listing mentions 3 months for medicines not listed, but the full timing rule is unclear.

Who can't join

  • You have ulcerative colitis or celiac disease, or have had a J-pouch, surgery to reroute stool, or surgery to remove part of your bowel.
  • You have complicated Crohn’s disease: active bowel narrowing in the past 12 months, disease that breaks through the bowel wall, or a draining tunnel near the anus.
  • In the past 4 weeks, you were hospitalized for inflammatory bowel disease, had C. difficile or another gut infection, or used probiotics.
  • You follow a specific carbohydrate, Mediterranean, or anti-inflammatory diet; need antibiotics during the study; or receive all nutrition through a vein at screening or during the study.
  • You have active cancer, heart failure, kidney failure at its final stage, or another serious or life-threatening condition.
  • You are pregnant, breastfeeding, or planning to become pregnant during the study.
  • You are under 16 or over 75, or are an adult unable to give consent to join.
  • You are a prisoner.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Study sites (1)

FL