Linaclotide for Colonoscopy Bowel Prep
University of Florida · NCT06692673
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–65 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Phase 1, Phase 2
- Target enrollment
- 10
- US sites recruiting
- 1
- Study start
- December 1, 2025
- Record last updated
- January 23, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the 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.
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.
Being studied: Use of Linaclotide as a single agent Colonoscopy prep
Conditions: Patients Scheduled for Colonoscopy
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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
Recruiting US locations
UF Health
Gainesville, FL 32608
Site contact: Johan Nordenstam, MD
Study contacts (from the official record)
- Pavel Mazirka, MD · (516) 203-6924 · pavel.mazirka@surgery.ufl.edu
- Oluwayemisi Ojewale, MD, MPH · (352) 594-5135 · oluwayemisi.ojewale@surgery.ufl.edu
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