10 Participants Needed

Linaclotide for Colonoscopy Preparation

JN
OO
PM
Overseen ByPavel Mazirka, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: University of Florida
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that patients already taking Linaclotide are excluded from participating.

How does the drug Linaclotide differ from other colonoscopy preparation treatments?

Linaclotide is unique for colonoscopy preparation because it is primarily used to treat chronic constipation and irritable bowel syndrome with constipation, working by increasing fluid secretion in the intestines to help with bowel movements. This mechanism may offer a novel approach compared to traditional laxatives used for colonoscopy prep.12345

Research Team

JN

Johan Nordenstam, MD PhD

Principal Investigator

University of Florida

Eligibility Criteria

This trial is for individuals needing a colonoscopy. Participants should be able to take Linaclotide and follow a clear liquid diet with Gatorade before the procedure. Details on who can't join are not provided, but typically those with allergies or conditions that could interfere with the drug or prep process would be excluded.

Exclusion Criteria

Patients who experienced hypersensitivity reactions to Linaclotide in the past
I have had surgery to remove part of my colon.
I have a colostomy.
See 8 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Preparation

Participants take Linaclotide and Gatorade as bowel preparation for colonoscopy

36 hours
1 visit (in-person)

Procedure

Participants undergo colonoscopy to assess bowel preparation quality

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the colonoscopy

48 hours

Treatment Details

Interventions

  • Linaclotide
Trial Overview The study tests if taking two doses of Linaclotide (one 36 hours before and another 8 hours prior) plus Gatorade provides adequate bowel preparation for a colonoscopy compared to the standard method using Polyethylene glycol.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Patients scheduled for ColonoscopyExperimental Treatment1 Intervention
Adult in-patients, 18 years of age and older, scheduled for an in-patient screening or diagnostic colonoscopy

Linaclotide is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Linzess for:
  • Chronic idiopathic constipation
  • Irritable bowel syndrome with constipation (IBS-C)
  • Functional constipation in pediatric patients 6 to 17 years of age
🇪🇺
Approved in European Union as Constella for:
  • Chronic idiopathic constipation
  • Irritable bowel syndrome with constipation (IBS-C)
🇨🇦
Approved in Canada as Linzess for:
  • Chronic idiopathic constipation
  • Irritable bowel syndrome with constipation (IBS-C)
  • Functional constipation in pediatric patients 6 to 17 years of age

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials
1,428
Recruited
987,000+

References

Preparation, characterization and pharmacokinetic studies of linalool-loaded nanostructured lipid carriers. [2019]
Lyophilized SLN of Cinnacalcet HCl: BBD enabled optimization, characterization and pharmacokinetic study. [2021]
Optimization of linalool-loaded solid lipid nanoparticles using experimental factorial design and long-term stability studies with a new centrifugal sedimentation method. [2019]
Design of lipotomes as a novel dual functioning nanocarrier for bioavailability enhancement of lacidipine: in-vitro and in-vivo characterization. [2014]
Evaluation of Manufacturer-to-Manufacturer Variability of Croscarmellose Sodium: Influence on the Dissolution of Sitagliptin Tablets (Water-Soluble Drug) and Escitalopram Tablets (Sparingly Soluble Drug). [2022]