Linaclotide as a lower-volume bowel prep for colonoscopy
Use of Linaclotide as a Single Agent Colonoscopy Bowel Preparation Regimen; A Pilot Trial
This trial tests whether linaclotide plus Gatorade can provide adequate bowel cleansing instead of the standard 4-liter PEG solution for adults having a colonoscopy.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT06692673 on ClinicalTrials.gov |
What this trial studies
This single-center, phase 1/2 interventional trial at the University of Florida gives hospitalized adults scheduled for colonoscopy two 290 mcg doses of linaclotide (36 and 8 hours before the procedure) combined with 2 liters of Gatorade and a clear liquid diet starting 24 hours before the exam, with NPO from midnight per standard care. The colonoscopy reports will be scored using the Boston Bowel Preparation Score (BBPS), and investigators will record insertion time, noted pathology, complications, and physician comments. The main comparison is adequacy of cleansing versus the usual 4 L polyethylene glycol (PEG) regimen, with safety and tolerability monitored. The protocol excludes patients with prior colon resection, colostomy, renal failure, pregnancy, inability to swallow pills, or current linaclotide use.
Who should consider this trial
Good fit: Adults aged 18–65 who are hospitalized and scheduled for colonoscopy, can swallow pills, are not pregnant, do not have prior colon resections or colostomy, do not have renal failure, and are not already taking linaclotide.
Not a fit: Patients with prior colon surgery, colostomy, severe renal failure, inability to swallow or use oral feeds, pregnancy, very low body weight, or current linaclotide use are unlikely to be eligible or to benefit from this regimen.
Why it matters
Potential benefit: If successful, this approach could offer a lower-volume, better-tolerated bowel preparation that avoids drinking 4 liters of PEG.
How similar studies have performed: Small prior reports have suggested linaclotide can reduce the volume of oral prep required, but using linaclotide as a single-agent substitute for 4 L PEG is novel and not yet proven.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Gainesville, Florida
- UF Health — Gainesville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Johan Nordenstam, MD PhD — University of Florida
- Study coordinator: Pavel Mazirka, MD
- Email: pavel.mazirka@surgery.ufl.edu
- Phone: (516) 203-6924
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.