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

RecruitingPhase 4Ages 18 Years - anyAllUniversity of Miami
NCT06774079 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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 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 family history of medullary thyroid cancer or in patients with Multiple Endocrine Neoplasia syndrome type 2 * Patients already on GIP/GLP-1 RA therapy * Patients with the following chronic symptoms: severe constipation, nausea, and/or vomiting * Patients with the following medical history: small bowel obstruction in the last year, intestinal stricture, known or suspected diagnosis of gastroparesis * Adults unable to consent * Pregnant patients (will be confirmed via a pregnancy test) * Prisoners
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What it tests

  • Tirzepatide
  • Mediterranean diet
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Where

1 site
University of Miami
Miami, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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