Recruiting
Phase 1
Phase 2

Linaclotide with Gatorade

Sponsor:

University of Florida

Code:

NCT06692673

Conditions

Patients Scheduled for Colonoscopy

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Use of Linaclotide as a single agent Colonoscopy prep

Study Details

Brief summary:

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.

Conditions

Patients Scheduled for Colonoscopy

Study ID

NCT06692673

Start date

Dec 1, 2025

Status verified date

Dec, 2025

Completion date

Jul 28, 2026

Anticipated

Primary completion date

Apr 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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 Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Patients scheduled for Colonoscopy

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

Interventions

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 measure

  • BBPS a cutoff 6 or greater [ Time Frame: Within 48 hours post Colonoscopy ]

Central Contacts and Locations

Central contacts

Pavel Mazirka, MD

(516) 203-6924pavel.mazirka@surgery.ufl.edu

Oluwayemisi Ojewale, MD, MPH

(352) 594-5135oluwayemisi.ojewale@surgery.ufl.edu

Locations

UF Health

Recruiting

Gainesville, Florida, United States, 32608

More Information

Sponsor

University of Florida

Last update posted

Jan 23, 2026

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-01-23.