Colonic NeoplasmsNCT05648318
Comparison of Oral Lactulose Versus Polyethylene Glycol for Bowel Preparation in Low-risk Patients
A study testing Lactulose oral solution and PEG in people with Colonic Neoplasms, run by Zhang Xiaofeng,MD at 1 site in China.
Trial summary
Adequate quality of bowel preparation(BP) is essential for colonoscopy. In recently, Kang suggested that for low-risk patients, single dose of 2L PEG is an effective regimen for bowel preparation.However, due to the poor palatability, there still more than 30% patients with 2L regimen experienced nausea or vomiting in… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonic Neoplasms
- What is being tested?
- Lactulose oral solution and PEG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- 1 siteChina
- Study dates
- 8 Jan 2022to 12 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients over 18 years old and with low-risk were eligible. Patients were considered as low risk if they did not meet any of the following risk factors: age>70 years old, body mass index (BMI)>25Kg/m2, constipation, Parkinson's disease, diabetes, history of stroke or spinal cord injury, use of tricyclic antidepressant or narcotics.
Who cannot join
- (1) history of colorectal resection; (2) Known or suspected colonic stricture or obstructing tumor; (3) Known or suspected colonic perforation; (4) toxic colitis or megacolon; (5) use of prokinetic agents or purgatives within 7 days; (6) hemodynamic instability; (7) pregnancy or lactation; (8) inability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 1L Oral Lactulose is an Effective Regimen for Bowel Preparation in Low-risk Patients
Adequate quality of bowel preparation(BP) is essential for colonoscopy. In recently, Kang suggested that for low-risk patients, single dose of 2L PEG is an effective regimen for bowel preparation.However, due to the poor palatability, there still more than 30% patients with 2L regimen experienced nausea or vomiting in our center.
Oral lactulose is a treatment for constipation. Several studies have compared the effectiveness between use PEG and lactulose for colonoscopy preparation in average-risk patients. However, the data in low-risk patients is vacant. The objective of current study was to compared the effectiveness of bowel preparation and patient tolerance using lactulose and 2L PEG regimen in low-risk patients.
- Conditions
- Colonic Neoplasms
- Being tested
- Lactulose oral solution, PEG
- Keywords
- colonoscopy, bowel preparation
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactulose oral solutionDrug
In the LOS group, patients were instructed to drink 200ml lactulose (Duphalac, Olst, the Netherlands; 200ml/bottle) diluted with clear water into 1L 4-6h before colonoscopy at a rate of 250ml every 30min.
PEGDrug
patient in the PEG group were instructed to drink 2L of PEG (each liter containing 59g PEG 4000, 1.46g sodium chloride, 5.68g sodium sulfate, 0.74g potassium chloride, 1.68g sodium bicarbonate; WanHe Pharmaceutical Co, Ltd., China) 4-6h before colonoscopy at a rate of 250ml every 15min
| Study group | Role | What they receive |
|---|---|---|
| Lactulose oral solution (LOS) | Experimental | Not described Receives: Drug: Lactulose oral solution |
| polyethylene glycol (PEG) | Active comparator | Not described Receives: Drug: PEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel preparation
Boston bowel preparation score (BBPS)：cleanliness of each part of the colon: 0=unprepared colon segment with mucosa not seen because of solid stool that cannot be cleared; 1=portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen because of staining, residual stool, and/or opaque liquid; 2=minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3=entire mucosa of colon segment seen well with no residual staining, small fragments of stool, or opaque liquid.
Measured: 1hour
Secondary outcomes (6)
Adverse events
Measured: 1hour
Willingness to repeat bowel preparation
We will ask patients in the form of questionnaire whether they are willing to repeat the same bowel preparation method if they need colonoscopy examination again
Measured: 1hour
Adenoma detection rate
Measured: 7 days
Cecal intubation rate
Measured: 1hour
insertion time
Measured: 1hour
withdrawal time
Measured: 1hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start8 Jan 2022
- Primary completion12 Sep 2022
- Study completion12 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhang Xiaofeng,MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhang Xiaofeng,MD, First People's Hospital of Hangzhou
- Investigators
- Xiaofeng Zhang, MD, Principal investigator, First People's Hospital of Hangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05648318
- Sponsor's protocol ID
- 20211206301
- Status last verified
- Dec 2022
- First submitted
- 5 Dec 2022
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 1L Oral Lactulose is an Effective Regimen for Bowel Preparation in Low-risk Patients
- ClinicalTrials.gov ID
- NCT05648318
- Acronym / sponsor ID
- 20211206301
- Conditions
- Colonic Neoplasms
- Keywords
- colonoscopy, bowel preparation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Zhang Xiaofeng,MDUniversity, hospital or other
- Study start
- 8 Jan 2022 (actual)
- Primary completion
- 12 Sep 2022 (actual)
- Study completion
- 12 Sep 2022 (actual)
- First posted
- 13 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Adequate quality of bowel preparation(BP) is essential for colonoscopy. In recently, Kang suggested that for low-risk patients, single dose of 2L PEG is an effective regimen for bowel preparation.However, due to the poor palatability, there still more than 30% patients with 2L regimen experienced nausea or vomiting in our center.
Oral lactulose is a treatment for constipation. Several studies have compared the effectiveness between use PEG and lactulose for colonoscopy preparation in average-risk patients. However, the data in low-risk patients is vacant. The objective of current study was to compared the effectiveness of bowel preparation and patient tolerance using lactulose and 2L PEG regimen in low-risk patients.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactulose oral solution (LOS) | Experimental | Drug: Lactulose oral solution |
| polyethylene glycol (PEG) | Active comparator | Drug: PEG |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over 18 years old and with low-risk were eligible. Patients were considered as low risk if they did not meet any of the following risk factors: age>70 years old, body mass index (BMI)>25Kg/m2, constipation, Parkinson's disease, diabetes, history of stroke or spinal cord injury, use of tricyclic antidepressant or narcotics.
Key exclusion criteria (1 listed)
- (1) history of colorectal resection; (2) Known or suspected colonic stricture or obstructing tumor; (3) Known or suspected colonic perforation; (4) toxic colitis or megacolon; (5) use of prokinetic agents or purgatives within 7 days; (6) hemodynamic instability; (7) pregnancy or lactation; (8) inability to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactulose oral solutionIn the LOS group, patients were instructed to drink 200ml lactulose (Duphalac, Olst, the Netherlands; 200ml/bottle) diluted with clear water into 1L 4-6h before colonoscopy at a rate of 250ml every 30min. | Drug | Lactulose oral solution (LOS) |
| PEGpatient in the PEG group were instructed to drink 2L of PEG (each liter containing 59g PEG 4000, 1.46g sodium chloride, 5.68g sodium sulfate, 0.74g potassium chloride, 1.68g sodium bicarbonate; WanHe Pharmaceutical Co, Ltd., China) 4-6h before colonoscopy at a rate of 250ml every 15min | Drug | polyethylene glycol (PEG) |
Primary outcome
Bowel preparation
Time frame: 1hour
Boston bowel preparation score (BBPS)：cleanliness of each part of the colon: 0=unprepared colon segment with mucosa not seen because of solid stool that cannot be cleared; 1=portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen because of staining, residual stool, and/or opaque liquid; 2=minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3=entire mucosa of colon segment seen well with no residual staining, small fragments of stool, or opaque liquid.
6 secondary outcomes
Adverse events
Time frame: 1hour
Willingness to repeat bowel preparation
Time frame: 1hour
Adenoma detection rate
Time frame: 7 days
Cecal intubation rate
Time frame: 1hour
insertion time
Time frame: 1hour
withdrawal time
Time frame: 1hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaofeng Zhang, MD principal investigator
First People's Hospital of Hangzhou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactulose oral solution and PEG in people with Colonic Neoplasms, run by Zhang Xiaofeng,MD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bowel preparation (time frame: 1hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2022.