A study to evaluate the Effectiveness of Polyethylene glycol (PEG) combined with linaclotide regimen versus the standard bowel preparation for adequacy of bowel preparation in high-risk and chronic constipated patients undergoing colonoscopy: A double-blinded double arm randomized controlled trial

Effectiveness of Polyethylene glycol (PEG) combined with linaclotide regimen for adequacy of bowel preparation in high-risk and chronic constipated patients undergoing colonoscopy: A single-blinded double arm randomized controlled trial

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/12/078393

Enrollment

430

Registered

2024-12-20

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: 2L PEG + Linaclotide bowel preparation for colonoscopy: Patients undergoing elective colonoscopy with standard split/same day dose of 2L PEG + Linaclotide bowel preparation Control Inte

Eligibility

Inclusion criteria

Inclusion criteria: 1.All consecutive consenting patients planned for elective colonoscopy for various indications in the department of Surgery and Medical gastroenterology. 2.High risk patients and patients with history of chronic constipation(Bristol stool form scale 1&2) 3. Prior history of inadequate bowel preparation

Exclusion criteria

Exclusion criteria: Bristol stool form scale (3-7) History of colorectal surgery Severe heart failure (New York Heart class II-IV) Patients with severe renal impairment (creatinine clearance those on hemodialysis or mental disorder Patients with history of bowel obstruction or resection History of taking linaclotide within 7 days or known linaclotide allergy Patients with known allergies to PEG Pregnant or lactating women Patients who were participating in other clinical trials Patients who did not provide written informed consent.

Design outcomes

Primary

Measure	Time frame
effect of adequacy of bowel preparation with linaclotideTimepoint: within 24 hours of the procedure	—

Secondary

Measure	Time frame
compliance of bowel preparation (PEG)? Patients acceptability & tolerability of bowel preparation? Drug compliance (Linaclotide)? Sleep disturbance in study patients ? Endoscopic findings? Caecal intubation time in minutes? Withdraw time in minutes? Total duration of procedure in minutes Patients’ satisfaction rate, acceptability & tolerability of procedure performed ? Willingness to repeat the same preparatory regimen ? Endoscopy nurse satisfaction with the quality of bowel preparation ? Incidence of colonoscopy related adverse events? Patients’ satisfaction with the whole bowel preparation & colonoscopyTimepoint: within 24 hours of colonoscopy	—

Measure

Time frame

compliance of bowel preparation (PEG)? Patients acceptability & tolerability of bowel preparation? Drug compliance (Linaclotide)? Sleep disturbance in study patients ? Endoscopic findings? Caecal intubation time in minutes? Withdraw time in minutes? Total duration of procedure in minutes Patients’ satisfaction rate, acceptability & tolerability of procedure performed ? Willingness to repeat the same preparatory regimen ? Endoscopy nurse satisfaction with the quality of bowel preparation ? Incidence of colonoscopy related adverse events? Patients’ satisfaction with the whole bowel preparation & colonoscopyTimepoint: within 24 hours of colonoscopy

—

Countries

India

Contacts

Public ContactKishore Kumar

Jawaharlal Institute of Postgraduate Medical Education and Research,

vijaymmc01@gmail.com9894561282

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026