Lactulose vs. Polyethylene Glycol as Bowel Preparation for Colonoscopy in Adults (NCT05726344) | Clinical Trial Compass
CompletedNot Applicable
Lactulose vs. Polyethylene Glycol as Bowel Preparation for Colonoscopy in Adults
Uruguay150 participantsStarted 2023-02-10
Plain-language summary
Colonoscopy is the gold standard in bowel assessment when there is suspicion of colon and rectum pathology. Bowel cleansing is necessary to ensure an optimal visualization of colonic mucosa, allowing this form of detection and removal of polyps. Nowadays international recommendations have multiple bowel preparations. There are differences among them regarding adherence, tolerance and adverse effects. Lactulose (LAC) is widely used in treating constipation. However, there are some randomized clinical assays using LAC as bowel preparation with excellent results according to bowel preparation and tolerance scales. Adherence to bowel preparation significantly affects the result in the endoscopic study.
Safety of polyethylene glycol (PEG) formulations has been validated in several studies, it presents little severe side effects and the advantage of its applicability to patients with several comorbidities (heart, liver and kidney without water deprivation). However, its main disadvantage lies in the need to ingest large amounts of liquid (3-4L), generating intolerance thereto in 15%-45% of patients.
Bowel cleansing preparation with PEG is widely used in clinical practice. Considering that according to international studies reporting better tolerance and adherence with LAC; it is suggested to compare the level of bowel preparation, tolerance and adherence between two groups with LAC and PEG.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
\- Patients over 18 years with no bowel surgical procedures
Exclusion Criteria:
* Patients willingly deciding not to enter into the study
* Pregnant women
* Patient with colonic resections and/or ileostomies
* Inflammatory bowel disease
* Colonic optimization by prior colonoscopy with poor preparation
* Suspected intestinal occlusion or perforation, intussusception
* Patient with melenas
* Oral iron intake in the past 10 days
* Emergency colonoscopy
* Hypersensitivity to any of the components comprised in preparations.
* Diabetics
* Chronic kidney disease in dialysis
* Uncorrected severe dystonias
* Severe psychiatric illness (schizophrenia)
* Low IQ to understand bowel preparation
* Severe constipation (\< 1 weekly stool)
* Chronic diarrhea with high rate (≥ 4 daily evenly loose consistency stools for more than 4 weeks)
* Unbalanced heart diseases (ischemic cardiopathology, congestive heart failure, unstable angina, arrhythmias and untreatable high blood pressure)
* Ascites
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Compare lactulose vs. Polyethylene Glycol as bowel cleansing preparation for colonoscopy
Timeframe: 6 months
2
Establish Boston Bowel Preparation Scale inter and intra-observer variability