Linaclotide for Colonoscopy Bowel Prep

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Phase 1 / Phase 2

Age range

18 years - 65 years

Sex eligible

All sexes

Healthy volunteers

Accepted

Participants

4 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean 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

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not applicable

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

University of Florida

Study start

Dec 1, 2025 Actual

Primary completion

Apr 7, 2026 Actual

Study completion

Apr 7, 2026 Actual

First posted

Nov 18, 2024 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.