Linaclotide for Colonoscopy Bowel Prep
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Use of Linaclotide as a single agent Colonoscopy prep.
- Who it may be relevant to
- Registry conditions: Patients Scheduled for Colonoscopy. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Use of Linaclotide as a Single Agent Colonoscopy Bowel Preparation Regimen; A Pilot Trial
Overview
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.
Detailed description
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.
Interventions
- Drug 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 measures
- BBPS a cutoff 6 or greater [Time frame: Within 48 hours post Colonoscopy]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- UF Health — Gainesville
Identifiers
NCT: NCT06692673 · IRB202400687