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Linaclotide for Colonoscopy Bowel Prep

Linaclotide for Colonoscopy Bowel Prep

Recruiting
18-65 years
All
Phase 1/2

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Overview

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 complications or physician noted comments.

Description

Linaclotide is a novel, FDA approved, intestinal prosecretory agent used to treat chronic constipation and irritable bowel syndrome. Linaclotide reduces colonic transit time and increases luminal fluid secretion. Use of Linaclotide in colonoscopy bowel preparation decreased the volume of oral prep required. We hypothesize that Linaclotide can be used as a single agent regimen to adequately prepare bowel for colonoscopy.

Eligibility

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

Study details
    Patients Scheduled for Colonoscopy

NCT06692673

University of Florida

31 January 2026

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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