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Linaclotide for Colonoscopy Bowel Prep

RecruitingPhase 1/2Healthy volunteers welcome

Use of Linaclotide as a Single Agent Colonoscopy Bowel Preparation Regimen; A Pilot Trial

Who can join

Ages 18 to 65 · All sexes · Healthy volunteers welcome

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: University of Florida · Participants: 10 · Started: Dec 1, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06692673

Locations in the U.S.

FloridaUF Health, Gainesville

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.