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NCT06692673 | NOT YET RECRUITING | Patients Scheduled for Colonoscopy

Linaclotide for Colonoscopy Bowel Prep
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.

Condition or disease

Patients Scheduled for Colonoscopy

Intervention/treatment

Use of Linaclotide as a single agent Colonoscopy prep

Phase

EARLY_PHASE1

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
Estimated Enrollment : 10 participants
Masking : NONE
Primary Purpose : PREVENTION
Official Title : Use of Linaclotide as a Single Agent Colonoscopy Bowel Preparation Regimen; A Pilot Trial
Actual Study Start Date : 2024-12-01
Estimated Primary Completion Date : 2025-08-31
Estimated Study Completion Date : 2025-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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
Linaclotide for Colonoscopy Bowel Prep

Location Details

NCT06692673

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Florida

UF Health

Gainesville, florida, United States, 32608