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Not yet recruiting NCT07671872

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

No phase Interventional Crohn's Disease, Active Crohn's Disease (CD) Diet Interventions

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Catered Anti-Inflammatory Diet, Diet Guidance for Usual Diet.
Who it may be relevant to
Registry conditions: Crohn's Disease, Active, Crohn's Disease (CD), Diet Interventions. Basic parameters: 16 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Behavioral Catered Anti-Inflammatory Diet
    Participants will receive a fully catered anti-inflammatory diet for 8 weeks, with meals delivered twice weekly. The diet is designed to provide \>25 g fiber/day, a \<3:1 n-6:n-3 fatty acid ratio, and \<30% of total calories from fat, and excludes red meat, processed meats, fried foods, emulsifiers, artificial sweeteners, food colorings, and other ultra-processed ingredients. Participants will also receive weekly remote sessions with a registered dietitian focused on dietary adherence, meal cust
  • Behavioral Diet Guidance for Usual Diet
    Participants will continue consuming their self-selected usual diet for 8 weeks. During this period, participants will receive weekly remote sessions with a registered dietitian focused on safe food handling, food preparation and cooking practices, and general nutrition education. Participants will also receive grocery gift cards to support food purchasing and to maintain equivalent contact time and participant engagement across study periods. No specific dietary pattern, food restrictions, or n

Primary outcome measures

  • Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response [Time frame: Baseline, Week 8, Week 10, Week 18]
  • Participants Achieving Fecal Calprotectin (FC) Reduction [Time frame: Baseline, Week 8, Week 10, Week 18]
Secondary outcome measures (1)
  • Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission [Time frame: Baseline, Week 8, Week 10, Week 18]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Miami — Miami

Identifiers

NCT: NCT07671872 · 20260433 · CDMRP-PR251962

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗