Actively Recruiting
Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RA) and Diet in Inflammatory Bowel Disease (IBD) Patients
Led by University of Miami · Updated on 2026-03-30
24
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to use diet and an injectable medication called tirzepatide (Zepbound) glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist (GIP-GLP-1 RA) medication as adjunctive therapy (another treatment used together with the primary treatment) for Crohn's disease patients with mild disease who are on stable doses of biologic medication (infliximab or adalimumab) and who have a body mass index (BMI) of at least 27.
CONDITIONS
Official Title
Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RA) and Diet in Inflammatory Bowel Disease (IBD) Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients (≥18 years old)
- Confirmed diagnosis of Crohn's disease
- Mildly active disease with Harvey Bradshaw Index (HBI) score between 5 and 7
- Body mass index (BMI) of 27 kg/m2 or higher
- On stable doses of anti-tumor necrosis factor (TNF) alpha blockers
You will not qualify if you...
- Patients under 18 years of age
- Patients with ulcerative colitis
- Patients with infectious colitis
- Body mass index (BMI) below 27 kg/m2
- Patients with type 1 or type 2 diabetes
- Contraindications to GIP/GLP-1 RA therapy, including personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia syndrome type 2
- Patients already using GIP/GLP-1 RA therapy
- Patients with severe constipation, nausea, or vomiting
- History of small bowel obstruction within the last year, intestinal stricture, or known/suspected gastroparesis
- Adults unable to provide consent
- Pregnant patients
- Prisoners
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
S
Stephanie Ioannou, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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