Linaclotide for Colonoscopy Bowel Prep

University of Florida

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Patients Scheduled for Colonoscopy

Treatments

Drug: Use of Linaclotide as a single agent Colonoscopy prep

Study type

Interventional

Funder types

Other

Identifiers

NCT06692673

IRB202400687

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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