Linaclotide for Colonoscopy Bowel Prep

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

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.

Study Overview

• Status: Recruiting
• Conditions: Patients Scheduled for Colonoscopy
• Intervention / Treatment: Drug: Use of Linaclotide as a single agent Colonoscopy prep

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Oluwayemisi Ojewale, MD, MPH; Phone Number: (352) 594-5135; Email: oluwayemisi.ojewale@surgery.ufl.edu
• Study Contact Backup: Name: Pavel Mazirka, MD; Phone Number: (516) 203-6924; Email: pavel.mazirka@surgery.ufl.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32608
      • Recruiting
      • UF Health
      • Contact: Johan Nordenstam, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients scheduled for Colonoscopy; Adult in-patients, 18 years of age and older, scheduled for an in-patient screening or diagnostic colonoscopy

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.; Other Names: Linaclotide prep

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BBPS a cutoff 6 or greater	Number of participants with Boston Bowel Preparation Scale (BBPS) of 6 or greater	Within 48 hours post Colonoscopy

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Johan Nordenstam, MD PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): July 28, 2026

Study Registration Dates

• First Submitted: November 12, 2024
• First Submitted That Met QC Criteria: November 14, 2024
• First Posted (Actual): November 18, 2024

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Guanylyl Cyclase C Agonists; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Enzyme Activators; Linaclotide
• Other Study ID Numbers: IRB202400687

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No