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Effect of linaclotide combined with polyethylene glycol electrolytes on bowel cleanliness in patients with chronic constipation

Effect of linaclotide combined with polyethylene glycol electrolytes on bowel cleanliness in patients with chronic constipation

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200057301
Enrollment
Unknown
Registered
2022-03-07
Start date
2022-03-07
Completion date
Unknown
Last updated
2023-10-09

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

Conditions

Bowel Preparation

Interventions

3L PEG+L group:add Linaclotide

Sponsors

The Affiliated People’s Hospital of Ningbo University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The diagnostic criteria for chronic constipation according to the Rome IV criteria: 1) must include two or more of the following: >25% of evacuations are labored; >25% of evacuations are dry bulbous or hard; >25% of evacuations are incomplete; >25% of evacuations have anorectal obstruction (or blockage); >25% of evacuations require manual assistance; spontaneous evacuations <3 times per week. 2) rare occurrence of dilute feces when laxatives are not used 3) Does not meet the diagnostic criteria for IBS. All functional gastrointestinal disorders must meet the symptom requirement for at least 6 months prior to diagnosis and within the last 3 months.

Exclusion criteria

Exclusion criteria: 1) Patients with a history of allergy to this study drug. 2) Patients with coexisting severe heart, liver, or kidney disease that cannot tolerate colonoscopy 3) Patients with coexisting intestinal obstruction, intestinal perforation and electrolyte disorders, and active inflammatory bowel disease 4) Patients with psychiatric history who cannot cooperate. 5) Pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
Bowel cleanliness (Boston Bowel Preparedness Rating Scale, Ottawa Bowel Preparedness Rating Scale);

Secondary

MeasureTime frame
Total incidence of adverse reactions: nausea and vomiting, abdominal pain and distension, dizziness and headache, weakness and fatigue;Entry time, withdrawal time;Detection rate of intestinal lesions;Willingness to repeat bowel preparation;Tolerance of the bowel preparation process;

Countries

China

Contacts

Public ContactHongliang Li

The Affiliated People’s Hospital of Ningbo University

air800@163.com057487017655

Outcome results

None listed

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