An interventional study of Catered Anti-Inflammatory Diet and Diet Guidance for Usual Diet in Crohn's Disease, Active, Crohn's Disease (CD) and Diet Interventions, sponsored by University of Miami. Recruiting at 1 site in United States. Open to participants aged 16 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by University of Miami · Not applicable, Interventional, and Treatment
Among 660 studies in Crohn Disease with a site in United States — 123 open to participants now, 164 under way, 35 of them phase 3. Crohn Disease · United States.
Among the 660 studies in Crohn Disease with a site in United States, this one is the 180th largest by planned enrollment of the 528 interventional ones, is one of 35 that started in 2026, is one of 128 with no phase, reaches primary completion later than 143 of the 162 other live ones, and was the 650th registered.
1,992 studies on the registry are indexed under Crohn Disease; 478 are open to participants now.
This study's planned enrollment of 122 is above the median of 67 across 1,260 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →123 of the 660 studies in Crohn Disease with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 354 Crohn Disease studies recruiting now, 155 (44%) set no upper age limit and 144 (41%) stop at 75 or younger; 96 take children under 18; 56 take healthy volunteers.
This study: 16 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →660 studies; the count open now beside each. This study's row is marked.
First in 1995; this study’s year is marked. 35 started in 2026.
Median enrollment 60 across the 528 interventional studies, 168 across the 128 observational. Of the 452 that completed or were terminated, 205 (45%) have results posted.
310 of 660 have an industry lead sponsor. The 10 most frequent:
University of Miami is the lead sponsor of 840 studies on the registry; 164 are open to participants now.
Of its 115 completed or terminated interventional studies of FDA-regulated products, 97 (84%) have results posted.
University of Miami has 6 studies filed under Crohn Disease — fewer than ten, so there is no comparison to draw.
59 of the studies in Crohn Disease with a site in United States that are under way reach primary completion within a year, 9 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06063967Phase 3AbbVieA Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease. | 2027-03 |
| NCT05347095Phase 3Janssen-Cilag Ltd.A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease | 2027-03-25 |
| NCT05660746Phase 3Children's Hospital Medical Center, CincinnatiPrecise Infliximab Exposure and Pharmacodynamic Control | 2027-03-31 |
| NCT06408935Phase 3Janssen-Cilag Ltd.Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients | 2027-06-08 |
| NCT06227910Phase 3TakedaA Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease | 2027-06-08 |
Among the 660 studies in Crohn Disease with a site in United States, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
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.
Behavioral: Catered Anti-Inflammatory Diet · Behavioral: Diet Guidance for Usual Diet
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.
Behavioral: Catered Anti-Inflammatory Diet · Behavioral: Diet Guidance for Usual 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 customization, grocery shopping, food affordability, and basic cooking skills.
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 nutrient intake targets will be prescribed during this phase.
Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response
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.
Time frame: Baseline, Week 8, Week 10, Week 18
Participants Achieving Fecal Calprotectin (FC) Reduction
Reduction is defined as a \>50% decrease from baseline in fecal calprotectin (FC). The outcome is the percentage of participants who achieve this reduction.
Time frame: Baseline, Week 8, Week 10, Week 18
Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission
Clinical Remission is defined as achieving a Crohn's Disease Activity Index (CDAI) score of \<150. The outcome is the percentage of participants who achieve this score.
Time frame: Baseline, Week 8, Week 10, Week 18
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Aug 2030, 47 months after the start.
Of 287 non-industry interventional studies with no phase under Crohn Disease, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 67. This study's planned 47 months is close to that.
Counting every sponsor, half of 299 studies reached it within 45 months; a quarter within 21 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
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