Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RA) and Diet in Inflammatory Bowel Disease (IBD) Patients

Last updated: April 28, 2025
Sponsor: University of Miami
Overall Status: Active - Recruiting

Phase

4

Condition

Gastrointestinal Diseases And Disorders

Treatment

Mediterranean diet

Tirzepatide

Clinical Study ID

NCT06774079
20240982
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients (≥18 years old)

  • Confirmed diagnosis of Crohn's disease

  • Mildly active disease, defined by clinical symptoms using the Harvey Bradshaw Index (HBI) score between 5 and 7 (the HBI is a continuous score ranging from 0-16 where <4 is considered remission)

  • BMI ≥ 27 kg/m2

  • Patients will be on stable doses of medical therapy (anti-tumor necrosis factor (TNF) alpha blockers)

Exclusion

Exclusion Criteria:

  • Patients under 18 years of age

  • Patients with ulcerative colitis

  • Patients with infectious colitis

  • BMI<27 kg/m2

  • Patients with type 1 or type 2 diabetes

  • Contraindications to a GIP/GLP-1 RA, including patients with a personal or familyhistory of medullary thyroid cancer or in patients with Multiple Endocrine Neoplasiasyndrome type 2

  • Patients already on GIP/GLP-1 RA therapy

  • Patients with the following chronic symptoms: severe constipation, nausea, and/orvomiting

  • Patients with the following medical history: small bowel obstruction in the lastyear, intestinal stricture, known or suspected diagnosis of gastroparesis

  • Adults unable to consent

  • Pregnant patients (will be confirmed via a pregnancy test)

  • Prisoners

Study Design

Total Participants: 24
Treatment Group(s): 2
Primary Treatment: Mediterranean diet
Phase: 4
Study Start date:
March 05, 2025
Estimated Completion Date:
March 05, 2026

Connect with a study center

  • University of Miami

    Miami, Florida 33136
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.