NCT06692673 · University of Florida
Linaclotide for Colonoscopy Bowel Prep
What this study is 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.
View original scientific description
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.
Interventions
DRUG
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.
Primary outcome measures
BBPS a cutoff 6 or greater
Time frame: Within 48 hours post Colonoscopy
Number of participants with Boston Bowel Preparation Scale (BBPS) of 6 or greater
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Gainesville, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 23, 2026 · Source of record for eligibility and locations