Efficacy, Tolerance and Safety of Split Dose Bowel Preparation for Colonoscopy: 4L Polyethylene Glycol (PEG) Versus 1L Polyethylene Glycol Plus Sodium Picosulfate-magnesium Citrate (SPMC)

NCT04474002 | Completed Phase 4

• 1 other identifier: PICO-PEG trial
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

4L split dose PEG is the gold standard for bowel preparation, however it comes with poor tolerability and poor compliance. Combination of PEG with different agent is useful in reducing total volume, improving compliance and tolerance of patient. The objective of this study is to demonstrate that combination bowel preparation, PEG plus SPMC solution, has similar efficacy and safety profile whereas with a better tolerance when compared to large volume PEG.

Conditions

Bowel Preparation Solutions; Colonoscopy

Keywords

Polyethylene glycol; Picoprep; Cathartics; Bowel preparation solution; Colonoscopy

Outcome Measures

Primary Outcomes (1)

• Boston Bowel Preparation Score (BBPS)

  Adequate bowel preparation is defined as a total BPPS score \>/= 6 in which all three segments had score \>/=2

  Up to 24 weeks

Secondary Outcomes (4)

• Patient tolerability to bowel preparation using Likert scale

  Up to 24 weeks

• Patient compliance towards bowel preparation

  Till the day of procedure

• Proportion of patient requiring repeat colonoscopy

  Up to 24 weeks

• Incidence of treatment related adverse events

  Up to 24 weeks

Study Arms (2)

4L Klean Prep®

ACTIVE COMPARATOR

Drug: 59g polyethylene glycol, 5.685g Na sulphate, 1.685g Na bicarbonate, 1.465g NaCl, 0.7425g KCl and aspartame 0.0494g

Drug: 4L Klean Prep®

1L Klean prep® and 2 sachets Picoprep®

EXPERIMENTAL

Drug: 59g polyethylene glycol, 5.685g Na sulphate, 1.685g Na bicarbonate, 1.465g NaCl, 0.7425g KCl, aspartame 0.0494g, sodium picosulfate 0.01g, magnesium oxide 3.5g, citric acid 12.0g

Drug: 1L Klean prep® and 2 sachets Picoprep®

Interventions

4L Klean Prep® DRUG

Patients allocated to the control group shall mix two sachets of PEG in 2L water. At 6pm the evening before examination, they shall consume 250ml solution every 15mins, and finish in 2hours. At 7am the day of examination, drink another 2L Klean-prep in 2 hours.

4L Klean Prep®

1L Klean prep® and 2 sachets Picoprep® DRUG

Patients allocated to the study group shall mix each sachet of Picoprep® in 150ml warm water. The patient shall take the 1st dose at 4pm the day before procedure followed by at least five 250ml drinks of clear fluid before the next dose. The 2nd dose shall be taken approximately 6hrs later and followed by at least three 250ml drinks of clear fluid before bed. On 7am the day of procedure, they shall take 1L PEG in 1 hour.

1L Klean prep® and 2 sachets Picoprep®

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient who mentally capable to consent for participating the trial
• years old
• Scheduled for 1st colonoscopy
• Elective outpatient colonoscopy

You may not qualify if:

• Prior colorectal or abdominal-pelvic surgery
• Inflammatory bowel disease
• Active bowel condition eg intestinal obstruction
• Gastrointestinal disorders eg active ulcer, gastric outlet obstruction, gastroparesis and hypomotility syndrome
• Recent myocardial infarction, congestive heart failure, uncontrolled hypertension
• Renal dysfunction, hepatic disease
• Patient on long term tranquilizer, anti-spasmodic, prokinetic, laxative or antidiarrhoeal agents
• Hypersensitivity to PEG or SPMC solution
• Pregnant or breastfeeding women
• Inability to give informed consent

Sponsors & Collaborators

• Queen Elizabeth Hospital, Hong Kong: lead

Study Sites (1)

Queen Elizabeth Hospital

Kowloon, Hong Kong

Location

MeSH Terms

Interventions

klean prep

Study Officials

• Yau Kan Tso

  Queen Elizabeth Hospital, Hospital Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: July 12, 2020
• First Posted: July 16, 2020
• Study Start: December 7, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)