Trial Outcomes & Findings for Bowel Preparation in Colonoscopy: Lactulose vs Polyethyleneglycol, Randomized Double-blind Comparative Clinical Trial, Multicenter Study. (NCT NCT06666556)
NCT ID: NCT06666556
Last Updated: 2026-07-28
Results Overview
Bowel cleansing quality was assessed using the Boston Bowel Preparation Scale (BBPS), which evaluates three segments of the colon (right, transverse, and left), each scored from 0 to 3, with a total score ranging from 0 to 9. Higher scores indicate better bowel preparation.
COMPLETED
PHASE4
449 participants
The duration of the study (approximately 20 to 30 minutes).
2026-07-28
Participant Flow
Adult patients scheduled for outpatient or inpatient colonoscopy at the Coloproctology Services of the Fray Antonio Alcalde Civil Hospital and Juan I Civil Hospital.
Patients will be randomly assigned to receive either polyethylene glycol or lactulose for bowel preparation. A randomization list will be generated and placed in sealed envelopes; neither the investigator nor the sub-investigators will know which preparation each patient will receive. The personnel responsible for generating the randomization list and preparing the envelopes will be part of the non-blinded team and will not participate in the endoscopic procedures.
Participant milestones
| Measure |
Bowel Preparation With Lactulose Before the Colonoscopy.
Patients will be randomized and assigned the bowel preparation on the day it is provided for the colonoscopy.
|
Bowel Preparation With Plyethylenglycol Before the Colonoscopy
Patients will be randomized and assigned the bowel preparation on the day it is provided for the colonoscopy.
|
|---|---|---|
|
Overall Study
STARTED
|
178
|
271
|
|
Overall Study
COMPLETED
|
178
|
271
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Patients with an indication for colonoscopy in the age range already mentioned.
Baseline characteristics by cohort
| Measure |
Bowel Preparation With Lactulose Before de Colonoscopy
n=178 Participants
Patients will be randomized and assigned the bowel preparation the day that provide them the day of the colonoscopy
|
Bowel Preparation With Plyethylenglycol Before the Colonoscopy
n=271 Participants
Patients will be randomized and assigned the bowel preparation the day that provide them the day of the colonoscopy
|
Total
n=449 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.65 Years
STANDARD_DEVIATION 13.10 • n=178 Participants • Patients with an indication for colonoscopy in the age range already mentioned.
|
55.62 Years
STANDARD_DEVIATION 14.29 • n=271 Participants • Patients with an indication for colonoscopy in the age range already mentioned.
|
56.42 Years
STANDARD_DEVIATION 13.83 • n=449 Participants • Patients with an indication for colonoscopy in the age range already mentioned.
|
|
Sex: Female, Male
Female
|
109 Participants
n=178 Participants
|
164 Participants
n=271 Participants
|
273 Participants
n=449 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=178 Participants
|
107 Participants
n=271 Participants
|
176 Participants
n=449 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: The duration of the study (approximately 20 to 30 minutes).Population: Differences in the number of patients between the bowel preparation groups may be related to factors such as intolerance to oral intake, voluntary withdrawal, or incomplete colonoscopy during the study process.
Bowel cleansing quality was assessed using the Boston Bowel Preparation Scale (BBPS), which evaluates three segments of the colon (right, transverse, and left), each scored from 0 to 3, with a total score ranging from 0 to 9. Higher scores indicate better bowel preparation.
Outcome measures
| Measure |
Bowel Preparation With Lactulose Before de Colonoscopy
n=178 Participants
Patients will be randomized and assigned the bowel preparation the day that provide them the day of the colonoscopy
|
Bowel Preparation With Plyethylenglycol Before the Colonoscopy
n=278 Participants
Patients will be randomized and assigned the bowel preparation the day that provide them the day of the colonoscopy
|
|---|---|---|
|
Bowel Cleansing Was Assessed Using the Boston Bowel Preparation Scale (BBPS).
|
7.21 Score scale
Standard Deviation 1.61
|
7.08 Score scale
Standard Deviation 1.49
|
SECONDARY outcome
Timeframe: At the completion of bowel preparation, prior to colonoscopy (approximately 8 hours before the procedure).Number of participants presenting gastrointestinal symptoms related to bowel preparation, including nausea, vomiting, abdominal pain, or abdominal distension.
Outcome measures
| Measure |
Bowel Preparation With Lactulose Before de Colonoscopy
n=178 Participants
Patients will be randomized and assigned the bowel preparation the day that provide them the day of the colonoscopy
|
Bowel Preparation With Plyethylenglycol Before the Colonoscopy
n=271 Participants
Patients will be randomized and assigned the bowel preparation the day that provide them the day of the colonoscopy
|
|---|---|---|
|
Number of Participants With Gastrointestinal Side Effects
|
100 Participants
|
100 Participants
|
SECONDARY outcome
Timeframe: 24 hours before your colonoscopyTolerability was assessed through direct patient questioning after completion of bowel preparation. Participants were classified as having tolerated or not tolerated the assigned bowel preparation according to their overall subjective experience. The analysis population consisted only of participants who completed the assigned bowel preparation and underwent colonoscopy. Participants excluded because of intolerance to the preparation were not included in this outcome analysis.
Outcome measures
| Measure |
Bowel Preparation With Lactulose Before de Colonoscopy
n=178 Participants
Patients will be randomized and assigned the bowel preparation the day that provide them the day of the colonoscopy
|
Bowel Preparation With Plyethylenglycol Before the Colonoscopy
n=271 Participants
Patients will be randomized and assigned the bowel preparation the day that provide them the day of the colonoscopy
|
|---|---|---|
|
Number of Participants Who Tolerated the Assigned Bowel Preparation
|
178 participants
|
271 participants
|
SECONDARY outcome
Timeframe: 24 hours before the colonoscopy while taking the assigned bowel preparationPopulation: Only participants who completed the assigned bowel preparation and underwent colonoscopy were included in this analysis. Participants who discontinued the preparation before completion were excluded from the analysis population.
Palatability was assessed by asking participants whether the taste of the assigned bowel preparation was acceptable. Participants were classified as having found the preparation palatable or not palatable based on their subjective response.
Outcome measures
| Measure |
Bowel Preparation With Lactulose Before de Colonoscopy
n=178 Participants
Patients will be randomized and assigned the bowel preparation the day that provide them the day of the colonoscopy
|
Bowel Preparation With Plyethylenglycol Before the Colonoscopy
n=271 Participants
Patients will be randomized and assigned the bowel preparation the day that provide them the day of the colonoscopy
|
|---|---|---|
|
Number of Participants Who Found the Bowel Preparation Palatable
|
100 Participants
|
100 Participants
|
Adverse Events
Bowel Preparation With Lactulose Before de Colonoscopy
Bowel Preparation With Plyethylenglycol Before the Colonoscopy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Roberto Ulises Cruz Neri.
Hospital Civil Antiguo de Guajadalara "Fray Antonio Alcalde"
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place