NCT06692673

Linaclotide for Colonoscopy Bowel Prep

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Patients Scheduled for Colonoscopy

Interventions

Type	Name	Description
DRUG	Use of Linaclotide as a single agent Colonoscopy prep	We plan to conduct a pilot study to determine the feasibility of a quality bowel preparation with two 290mg doses of Linaclotide (first dose given 36 hours before, and the other 8 hours prior to the procedure) along with 2 Liters of Gatorade (to prevent dehydration) given the day prior to the colonoscopy instead of the current standard 4 liters of PEG regimen. All study participants will be asked to consume a clear liquid diet for 24hours before the procedure.

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-04-30
• Completion: 2026-07-28
• First posted: 2024-11-18
• Last updated: 2026-01-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study