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Ultra-low Split-dose Oral Lactulose vs High-volume Split-dose Polyethylene Glycol as Bowel Preparation for Outpatient Colonoscopies.

NCT07787897 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-08-26

No results posted yet for this study

Summary

This study compared two different ways to clean the bowel before a colonoscopy: lactulose (a sweet syrup mixed with water) versus high-volume polyethylene glycol (PEG, the usual standard treatment). The goal was to find out which one cleans the bowel better, is easier for patients to take, and has fewer side effects.

Researchers wanted to answer these main questions:

Does lactulose clean the bowel as well as PEG according to the Boston Bowel Preparation Scale? Which preparation do patients find more pleasant and are more willing to repeat in the future? Are there differences in side effects such as nausea, vomiting, bloating, or belly pain? Do the two preparations affect how well doctors can see inside the colon, including the chance of finding polyps?

Adults aged 45 to 75 years who were scheduled for a routine outpatient colonoscopy at the Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán in Mexico City were invited to take part. People with certain serious medical conditions (such as advanced liver disease, kidney failure on dialysis, heart failure, pregnancy, or previous colon surgery) could not join.

Participants were randomly assigned to one of two groups:

Lactulose group: 125 ml of lactulose mixed in 600 ml of water the evening before, and again early the next morning.

PEG group: 2 liters of PEG solution the evening before, and another 2 liters early the next morning.

Both preparations were finished by 6:00 a.m. All participants followed a low-fiber diet the day before the procedure. Doctors performing the colonoscopy did not know which preparation each patient had used.

The study included 200 people (100 in each group).

Conditions

  • Colonoscopy

Interventions

DRUG

lactulose

Lactulose: 125 ml of lactulose (10 g/15 ml) in 600 ml of water will be administered between 9:00 PM and 10:00 PM on the night before the study; subsequently, between 5:00 AM and 6:00 AM on the day of the study, another 125 ml of lactulose (10 g/15 ml) in 600 ml of water will be administered.

DRUG

polyethylene glycol (PEG)

Polyethylene glycol: 2 sachets of 109.6 grams each, dissolved in 2 liters of water, to be taken between 8:00 PM and 10:00 PM on the night before the study; subsequently, between 4:00 AM and 6:00 AM on the day of the study, another 2 sachets of 109.6 grams each, dissolved in 2 liters of water, are to be administered.

Sponsors & Collaborators

  • National Institute of Medical Sciences and Nutrition, Salvador Zubiran

    lead OTHER

Principal Investigators

  • Ricardo Macias, Doctor · National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-29
Primary Completion
2024-10-30
Completion
2025-12-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07787897 on ClinicalTrials.gov