Linaclotide for Colonoscopy Bowel Prep

Conditions

• Patients Scheduled for Colonoscopy

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Accepted

Interventions

• Use of Linaclotide as a single agent Colonoscopy prep — DRUG
  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.

Study Details

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.

Key Dates

Start date

Dec 1, 2025

Status verified

Dec 2025

Primary completion

Apr 30, 2026

Completion

Jul 28, 2026

Study Design

Enrollment

10 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Arms

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

Primary Outcome Measure

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

Central Contacts

• Pavel Mazirka, MD
  (516) 203-6924
  [email protected]
• Oluwayemisi Ojewale, MD, MPH
  (352) 594-5135
  [email protected]

Locations (1)

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