Linaclotide for Colonoscopy Bowel Prep

NCT ID: NCT06692673

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2026-07-28

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.

Conditions

Patients Scheduled for Colonoscopy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Patients scheduled for Colonoscopy

Adult in-patients, 18 years of age and older, scheduled for an in-patient screening or diagnostic colonoscopy

Group Type: EXPERIMENTAL

Use of Linaclotide as a single agent Colonoscopy prep

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Linaclotide prep

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johan Nordenstam, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

UF Health

Gainesville, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Pavel Mazirka, MD

Role: CONTACT

pavel.mazirka@surgery.ufl.edu

(516) 203-6924

Oluwayemisi Ojewale, MD, MPH

Role: CONTACT

oluwayemisi.ojewale@surgery.ufl.edu

(352) 594-5135

Facility Contacts

Johan Nordenstam, MD

Role: primary

Other Identifiers

IRB202400687

Identifier Type: -

Identifier Source: org_study_id