Recruiting

Linaclotide for Colonoscopy Bowel Preparation

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What is being tested

Use of Linaclotide as a single agent Colonoscopy prep

Drug
Who is being recruted

From 18 to 65 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 1 & 2
Interventional
Study Start: December 2025
See protocol details

Summary

Principal SponsorUniversity of Florida
Study ContactPavel Mazirka, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2025

Actual date on which the first participant was enrolled.

This study is exploring the use of Linaclotide, a medication already approved for treating chronic constipation and irritable bowel syndrome, as a possible new method for preparing the bowel before a colonoscopy. Colonoscopy is a procedure that requires a clean bowel to give doctors a clear view. Traditionally, bowel preparation involves drinking large volumes of liquid solutions, which can be uncomfortable. Researchers are investigating whether Linaclotide can effectively prepare the bowel on its own, potentially reducing the amount of liquid a patient needs to drink before the procedure. This could make the preparation process more comfortable for patients. Participants in this study will receive Linaclotide as the only agent to prepare their bowels for a colonoscopy. The medication works by speeding up the movement through the intestine and increasing fluid in the bowel, helping to clear it out. The study will assess how well Linaclotide cleans the bowel and whether it provides a clear enough view for the colonoscopy. The aim is to see if Linaclotide can be a stand-alone preparation method, which could simplify and improve the experience for patients undergoing this important screening procedure.

Official TitleUse of Linaclotide as a Single Agent Colonoscopy Bowel Preparation Regimen; A Pilot Trial
NCT06692673
Principal SponsorUniversity of Florida
Study ContactPavel Mazirka, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Adult in-patients, 18 years of age and older, scheduled for an in-patient screening or diagnostic colonoscopy

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

UF Health

Gainesville, United StatesOpen UF Health in Google Maps
Recruiting
One Study Center