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Linaclotide for Colonoscopy Bowel Prep

RecruitingPhase 1, Phase 2Ages 18 Years - 65 YearsAllUniversity of Florida
NCT06692673 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to learn if drug Linaclotide can be used as a single agent regimen to adequately prepare bowel for colonoscopy. The main question it aims to answer is: Does drug Linaclotide with Gatorade provide adequate bowel preparation for colonoscopy instead of the standard 4 Liters of Polyethylene glycol (PEG)? Participants will: Take one 290mg dose of Linaclotide 36 hours before the procedure and One 290mg dose of Linaclotide 8 hours before the procedure + 2 Liters of Gatorade and a clear liquid diet 24 hours before the procedure. As per standard of care, all patients will be made Nil Per Oral (NPO) starting midnight before the procedure. The colonoscopy report will then be reviewed for Boston Bowel Preparation Score (BBPS) as a marker of bowel preparation quality, insertion time as a marker of procedure difficulty as well as noted pathology and any complica

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adult male and female patients (age 18 years to 65) admitted, who are scheduled for a colonoscopy during their admission. Exclusion Criteria: * Pregnant patients * Patients with weight less than 116 pounds * Patients with prior colon resection surgeries * Presence of colostomy * Patients undergoing sigmoidoscopy or pouchoscopy * Patients unable to swallow pills/tablets * Patients who would use a G or J feeding tubes to administer medications/preparation regimen * Patients who are unable to consent for themselves * Patients with a history of renal failure * Patients already taking Linaclotide * Patients who experienced hypersensitivity reactions to Linaclotide in the past
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What it tests

  • Use of Linaclotide as a single agent Colonoscopy prep
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Where

1 site
UF Health
Gainesville, 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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