Crohn's Disease Clinical Trials

Find Crohn's Disease Clinical Trials Near You

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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 75
Healthy Volunteers: f
View:

⁃ 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

Locations
United States
Florida
University of Miami
RECRUITING
Miami
Contact Information
Primary
Eytan I Stern, MS, RD, LD/N, CNSC
eis43@miami.edu
305-243-6405
Time Frame
Start Date: 2026-09-16
Estimated Completion Date: 2030-08
Participants
Target number of participants: 122
Treatments
Experimental: Sequence A→B: Catered Anti-Inflammatory Diet Followed by Diet Guidance Group
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.
Experimental: Sequence B→A: Diet Guidance Followed by Catered Anti-Inflammatory Diet Group
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.
Related Therapeutic Areas
Sponsors
Collaborators: United States Department of Defense
Leads: University of Miami

This content was sourced from clinicaltrials.gov