Linaclotide for Colonoscopy Bowel Prep

Phase 1

Not yet recruiting

• Conditions: Patients Scheduled for Colonoscopy
• Interventions: Drug: Use of Linaclotide as a single agent Colonoscopy prep

• Registration Number: NCT06692673
• Lead Sponsor: University of Florida

Brief 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.

Study Timeline

• Study First Submitted: 2024-11-12
• Study First Submitted QC: 2024-11-14
• Study First Posted: 2024-11-18
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-08
• Last Update Posted: 2025-07-10
• Study Start: 2025-09-01
• Primary Completion: 2025-12-30
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients scheduled for Colonoscopy	Use of Linaclotide as a single agent Colonoscopy prep	Adult in-patients, 18 years of age and older, scheduled for an in-patient screening or diagnostic colonoscopy

Primary Outcome Measures

Name	Time	Method
BBPS a cutoff 6 or greater	Within 48 hours post Colonoscopy	Number of participants with Boston Bowel Preparation Scale (BBPS) of 6 or greater

Trial Locations

Locations (1)

UF Health; 🇺🇸 Gainesville, Florida, United States