Crohn'sRecruiting
Tailored Anti-Inflammatory American Diet for Patients With Crohn's Disease
Not applicable · Testing Catered Anti-Inflammatory Diet and Diet Guidance for Usual Diet · 1 site · University of Miami
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Catered Anti-Inflammatory Diet (a behavioral program) and Diet Guidance for Usual Diet (a behavioral program) as a possible treatment. Condition(s) listed: Crohn's Disease, Active, Crohn's Disease (CD) and Diet Interventions.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 16 to 75
- Any sex
Some of the main requirements, copied from the record:
- 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…
- -On stable medications for their disease as or 3 months if medication is not listed
There are also 16 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 122 participants are expected to take part.
- The study has 2 groups.
- Start date: 2026-09-16.
- Main results expected around 2030-08 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Groups in this study
- Sequence A→B: Catered Anti-Inflammatory Diet Followed by Diet Guidance Group (listed as: experimental group)
- Sequence B→A: Diet Guidance Followed by Catered Anti-Inflammatory Diet Group (listed as: experimental group)
Main thing being measured
- Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response (Baseline, Week 8, Week 10, Week 18)
- Participants Achieving Fecal Calprotectin (FC) Reduction (Baseline, Week 8, Week 10, Week 18)
In the researchers’ words
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.
Words you might see
- Fecal calprotectin: a stool test that measures inflammation in the gut.
- Endoscopy: a camera exam inside the digestive tract.
- CDAI: Crohn's Disease Activity Index, a score of how active Crohn's disease is.
- Fistula: an abnormal tunnel between two parts of the body, which can happen in Crohn's disease.
- Stricture: a narrowing (of the bowel or of a bile duct).
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Crohn's Disease, Active; Crohn's Disease (CD); Diet Interventions |
| Lead sponsor | University of Miami |
| Collaborators | United States Department of Defense |
| Enrollment | 122 (estimated) |
| Start date | 2026-09-16 |
| Primary completion (est.) | 2030-08 |
| First posted | 2026-06-26 |
| Last updated | 2026-09-24 |
| Official title | Targeting Gut Inflammation Through Diet: a Tailored American Diet for Patients With Crohn's Disease |
| ClinicalTrials.gov ID | NCT07671872 |
Interventions
- Catered Anti-Inflammatory Diet (Behavioral)
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 r… - Diet Guidance for Usual Diet (Behavioral)
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 a…
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| University of Miami | Miami, Florida | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.