UF Health
Gainesville, Florida, 32608, United States
Location status: Recruiting
Location contact
Johan Nordenstam, MD
CONTACT
Recruiting
NCT Number: NCT06692673
Linaclotide for Colonoscopy Bowel Prep
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1 / Phase 2
Primary location
About this study
Linaclotide is a novel, FDA approved, intestinal prosecretory agent used to treat chronic constipation and irritable bowel syndrome. Linaclotide reduces colonic transit time and increases luminal fluid secretion. Use of Linaclotide in colonoscopy bowel preparation decreased the volume of oral prep required. We hypothesize that Linaclotide can be used as a single agent regimen to adequately prepare bowel for colonoscopy.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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 and study plan
Use of Linaclotide as a single agent Colonoscopy prep
DrugWe 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.
Other names: Linaclotide prep
Primary outcomes
-
BBPS a cutoff 6 or greater
Time frame: Within 48 hours post Colonoscopy
Number of participants with Boston Bowel Preparation Scale (BBPS) of 6 or greater
Study contacts
Contact information is provided by the study sponsor or research team.
Oluwayemisi Ojewale, MD, MPH
CONTACT
Pavel Mazirka, MD
CONTACT
Sponsors and collaborators
Lead sponsor
University of Florida
Other
Registry information
Official study title
Use of Linaclotide as a Single Agent Colonoscopy Bowel Preparation Regimen; A Pilot Trial
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Nov 18, 2024
- Registry last updated
- Jan 23, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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