Linaclotide for Colonoscopy Preparation
Trial Summary
What is the purpose of this 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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, it does mention that patients already taking Linaclotide are excluded from participating.
How does the drug Linaclotide differ from other colonoscopy preparation treatments?
Linaclotide is unique for colonoscopy preparation because it is primarily used to treat chronic constipation and irritable bowel syndrome with constipation, working by increasing fluid secretion in the intestines to help with bowel movements. This mechanism may offer a novel approach compared to traditional laxatives used for colonoscopy prep.12345
Research Team
Johan Nordenstam, MD PhD
Principal Investigator
University of Florida
Eligibility Criteria
This trial is for individuals needing a colonoscopy. Participants should be able to take Linaclotide and follow a clear liquid diet with Gatorade before the procedure. Details on who can't join are not provided, but typically those with allergies or conditions that could interfere with the drug or prep process would be excluded.Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Preparation
Participants take Linaclotide and Gatorade as bowel preparation for colonoscopy
Procedure
Participants undergo colonoscopy to assess bowel preparation quality
Follow-up
Participants are monitored for safety and effectiveness after the colonoscopy
Treatment Details
Interventions
- Linaclotide
Linaclotide is already approved in United States, European Union, Canada for the following indications:
- Chronic idiopathic constipation
- Irritable bowel syndrome with constipation (IBS-C)
- Functional constipation in pediatric patients 6 to 17 years of age
- Chronic idiopathic constipation
- Irritable bowel syndrome with constipation (IBS-C)
- Chronic idiopathic constipation
- Irritable bowel syndrome with constipation (IBS-C)
- Functional constipation in pediatric patients 6 to 17 years of age
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Florida
Lead Sponsor