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Comparison of Polyethylene Glycol Combined with Lubiprostone versus Standard-Dose Polyethylene Glycol for Bowel Preparation Before Colonoscopy in Patients with Chronic Constipation: A Multicenter Randomized Controlled Trial

Comparison of Polyethylene Glycol Combined with Lubiprostone versus Standard-Dose Polyethylene Glycol for Bowel Preparation Before Colonoscopy in Patients with Chronic Constipation: A Multicenter Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112886
Enrollment
Unknown
Registered
2025-11-20
Start date
2026-03-02
Completion date
Unknown
Last updated
2025-11-24

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

Conditions

Intestinal preparation before colonoscopy for individuals with chronic constipation

Interventions

Experimental group:2 L PEG3350 + Lubiprostone
Control group:2 L PEG3350

Sponsors

The First Affiliated Hospital of Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18–75 years, both male and female; 2.Scheduled to undergo colonoscopy, with no history of colonoscopy within 1 month prior to enrollment in the study; 3.Patients with chronic constipation, defined as either primary constipation (presence of constipation symptoms, i.e., fewer than 3 bowel movements per week, with symptom duration of =6 months) or secondary constipation (constipation directly or indirectly caused by definite organic diseases, systemic diseases, adverse drug effects, or lifestyle factors); 4.Voluntarily participate in this study and sign the informed consent form;

Exclusion criteria

Exclusion criteria: 1.Patients with a known allergy to the bowel preparation medications used in the study; 2.Patients who have taken gastroprokinetic agents or laxatives within 1 week prior to enrollment; 3.Patients with refractory constipation: Refractory constipation is defined as a condition that meets the basic definition of chronic constipation, and for which there is no significant improvement in symptoms after receiving standardized treatment with at least 2 types of laxatives with different mechanisms of action (e.g., osmotic laxatives + prokinetic agents) for = 4 weeks, or pelvic floor biofeedback therapy for = 3 months; 4.Patients with contraindications to colonoscopy, including: severe cardiopulmonary diseases with inability to tolerate endoscopic examination; uncorrected shock or hemodynamic instability; severe thoracoabdominal aortic aneurysm; history of stroke; severe coagulation disorders; gastrointestinal obstruction or perforation, severe active inflammation or toxic megacolon; presence of psychiatric disorders or inability to cooperate with the investigator; 5.Patients with liver cirrhosis complicated by ascites or chronic kidney disease; 6.Pregnant or lactating women; 7.Patients who are already participating in other drug/device studies or are in the follow-up period of another drug/device study; 8.Other conditions deemed unsuitable for study participation by the investigator(s), such as alcoholics, patients with psychiatric disorders, etc.

Design outcomes

Primary

MeasureTime frame
Qualified rate of intestinal preparation;

Secondary

MeasureTime frame
Check comfort rating;Polyp detection rate;Participants compliance;Adverse events incidence rate;BBPS score;Cecal intubation rate;Mirror entry time;Adenoma detection rate;Withdrawal time;

Countries

China

Contacts

Public ContactChai Jin

The First Affiliated Hospital of Army Medical University

jin.chai@cldcsw.org+86 13996402074

Outcome results

None listed

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