Linaclotide for Colonoscopy Preparation
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether Linaclotide can prepare the bowel for a colonoscopy using less liquid than the usual method. The goal is to determine if Linaclotide, combined with Gatorade and a clear liquid diet, can effectively replace the standard 4 liters of another solution. The trial seeks adults admitted to the hospital who are scheduled for a colonoscopy and have not had colon surgeries or certain health issues like renal failure. Participants will take two doses of Linaclotide before their procedure to test this new preparation method. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.
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.
Is there any evidence suggesting that Linaclotide is likely to be safe for use in colonoscopy preparation?
Research has shown that linaclotide is generally safe for humans. Its approval for treating irritable bowel syndrome with constipation (IBS-C) supports its safety for other uses. Studies indicate that using linaclotide with standard bowel prep solutions like polyethylene glycol (PEG) enhances bowel cleaning without adding safety risks.
When combined with PEG, linaclotide improves bowel cleaning and aids in detecting more polyps during colonoscopies, while maintaining safety. However, linaclotide can cause serious dehydration in children, so it is not used for them.
Overall, linaclotide is well-tolerated in adults, with no major side effects reported when used for bowel preparation.12345Why do researchers think this study treatment might be promising?
Unlike the standard colonoscopy prep options, which usually involve strong laxatives and a lot of liquid intake, linaclotide offers a new approach. Linaclotide works by increasing the secretion of chloride and water in the intestines, which helps to clear the bowels in a potentially gentler way. Researchers are excited because this mechanism might reduce the discomfort and unpleasantness typically associated with traditional colonoscopy preparations. Additionally, linaclotide is already known for treating chronic constipation and irritable bowel syndrome, which suggests it could offer a dual benefit of prep efficiency and comfort.
What evidence suggests that Linaclotide might be an effective treatment for colonoscopy preparation?
Research has shown that Linaclotide can help prepare bowels for a colonoscopy. In this trial, participants will receive Linaclotide with a smaller amount of the usual prep solution. Studies indicate that Linaclotide increases the likelihood of achieving a clean bowel, and using it with less prep solution resulted in better bowel cleaning than the standard large amount of solution. Linaclotide increases fluid in the intestines, aiding in bowel cleaning. These findings suggest that Linaclotide could simplify colonoscopy preparation by reducing the amount of liquid needed.678910
Who Is on the Research Team?
Johan Nordenstam, MD PhD
Principal Investigator
University of Florida
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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