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Combination Lubiprostone and Split-Dose PEG-ELS Vs Split-Dose PEG-ELS alone for bowel preparation before colonoscopy in constipated patients: A prospective, endoscopist-blinded, randomized controlled trial

Combination Lubiprostone and Split-Dose PEG-ELS Vs Split-Dose PEG-ELS alone for bowel preparation before colonoscopy in constipated patients: A prospective, endoscopist-blinded, randomized controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20230411007
Enrollment
68
Registered
2023-04-11
Start date
2020-01-28
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Colorectal cancer increased incidences in Thailand annually, which was most commonly diagnosed in the advanced stage while less than 50% was diagnosed in stages I and II. Colonoscopy was considered a standard and common-used method for the screening, diagnosis, and treatment of disease today. Chronic constipation would affect cleansing during bowel preparation. In a foreign study, the preparation of the large intestine in people with constipation showed that the Split-dose of polyethylene glycol

Interventions

split-dose PEG-ELS combination with Lubiprostone 3 times by specifying as follows
2 days before colonoscopy 1 capsule of Lubiprostone at 6.00 a.m. then took 1 capsule of Lubiprostone at 6 p.m. Day before colonoscopy - 1 capsule of Lubiprostone at 6.00 a.m. The subjects would recei
Active Comparator Drug,Placebo Comparator Drug
split-dose PEG-ELS combination with Lubiprostone 3 times ,split-dose PEG-ELS combination

Sponsors

Dr. Kawin Tangvoraphonkchai
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 18-75 years of age patients that are indicated for colonoscopy with constipation (Compatible with ROME IV diagnostic criteria for chronic constipation or history of Bristol stool form scale 1-2).

Exclusion criteria

Exclusion criteria: Suspected bowel obstruction or perforation, uncontrolled condition e.g. congestive heart failure, unstable angina pectoris, unstable hypertension, cardiac arrhythmia, liver failure, acute kidney injury, uncontrolled blood glucose, hypo-hyperthyroid state, cannot stop warfarin for 3 days, cannot stop antiplatelet for 7 days, history of colectomy, pregnancy or breastfeeding, history of drug allergy for PEG-ELS or Lubiprostone, coagulopathy(INR > 1.5), and thrombocytopenia (< 50000 /ul).

Design outcomes

Primary

MeasureTime frame
the Ottawa bowel preparation score Colonoscopy day proportion of adequate bowel cleansing

Secondary

MeasureTime frame
adenoma detection rate Colonoscopy day Number of adenoma,safety profiles Colonoscopy day symptoms,satisfaction Colonoscopy day a questionnaire to assess the satisfaction

Countries

Thailand

Contacts

Public ContactKawin Tangvoraphonkchai

Srinagarind Hospital Khonkaen University

kawin_tang@hotmail.com0817082108

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026