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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• Adult male and female patients (age 18 years to 65) admitted, who are scheduled for a colonoscopy during their admission.

Locations
United States
Florida
UF Health
RECRUITING
Gainesville
Contact Information
Primary
Pavel Mazirka, MD
pavel.mazirka@surgery.ufl.edu
(516) 203-6924
Backup
Oluwayemisi Ojewale, MD, MPH
oluwayemisi.ojewale@surgery.ufl.edu
(352) 594-5135
Time Frame
Start Date: 2025-12-01
Estimated Completion Date: 2026-07-28
Participants
Target number of participants: 10
Treatments
Experimental: Patients scheduled for Colonoscopy
Adult in-patients, 18 years of age and older, scheduled for an in-patient screening or diagnostic colonoscopy
Related Therapeutic Areas
Sponsors
Leads: University of Florida

This content was sourced from clinicaltrials.gov

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