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NCT06692673·Phase 1 / Phase 2·INTERVENTIONAL

Linaclotide for Colonoscopy Bowel Prep

LinaclotideOtherRecruiting

Status

Recruiting

Phase

Phase 1 / Phase 2

Enrollment

10

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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

Treatment arms and agents.

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.

Timeline

From registration to results.

  1. First posted

    Nov 18, 2024

  2. Study start

    Dec 1, 2025

  3. Primary completion

    Apr 30, 2026

  4. Study completion

    Jul 28, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Jan 23, 2026

Outcomes

What the study measures.

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

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
65 Years
Sex
ALL
Healthy volunteers
Yes

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 locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

UF Health

Gainesville, Florida, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

Related trials

More studies on Linaclotide.

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Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.

TrialsLinaclotide trial dashboard →