ColonoscopyPhase 3NCT05076799
Effect of Lactulose and/or Polyethylene Glycol Solution for Bowel Preparation for Colonscopy Procedures
A Phase 3 study testing 100 ml lactulose combined with 1 L PEG, 100 ml lactulose combined with 2 L PEG and 200 ml lactulose in people with Colonoscopy, run by Sichuan University at 1 site in China.
Trial summary
Colonoscopy is the most useful exam used to evaluate colorectal diseases, like colorectal polyps and cancer. The appropriate bowel preparation is indispensable for colonoscopy procedures. Polyethylene glycol solution (PEG) is the most frequent laxative medication. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy
- What is being tested?
- 100 ml lactulose combined with 1 L PEG, 100 ml lactulose combined with 2 L PEG and 200 ml lactulose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 30 Nov 2022
- Phase
- Phase 3
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants who were scheduled for colonoscopy age between 18 and 80 years
Who cannot join
- uncontrolled acute or recurrent chronic intestinal infections
- active gastrointestinal bleeding, gastrointestinal stricture, intestinal obstruction
- severe electrolyte metabolism disorder, severe coronary heart disease, heart failure, renal failure or liver failure
- pregnant, lactating, have metal diseases or refuse to colonoscopy examination
Trial locations and contacts
1 site in 1 country.
China1 site
west china fourth hospital of Sichuan university
Chengdu, Sichuan, 610014
About this study
Official title: Effect of Lactulose and/ or Polyethylene Glycol Solution for Bowel Preparation in Colonscopy: a Multi-center Prospective Randomized Study
Colonoscopy is the most useful exam used to evaluate colorectal diseases, like colorectal polyps and cancer. The appropriate bowel preparation is indispensable for colonoscopy procedures. Polyethylene glycol solution (PEG) is the most frequent laxative medication. However, the taste is poor, and patients need to drink a lot of liquids to obtain adequate visualization of the mucosal surface. In fact, no laxative has all the characteristics of an ideal medication. Lactulose is an osmotic laxative which widely used in cirrhosis and constipation patients, and could inhibit bacterial in the colon to increase colon cleanliness and prolong the effect time of PEG. Previous study demonstrate PEG combined with lactulose has a significant improvement in the quality of bowel preparation compared with PEG alone. The present study aim to assess the efficacy of lactulose with or without PEG in bowel preparation to improve mucosal visualization, reduced volume of fluid consumed, and preparation intolerance.
Read the detailed description
This study will conduct in 5 clinical central. 1000 participants who were scheduled for colonoscopy age between 18 and 80 years were enrolled in the study. Exclusion criteria were patients with uncontrolled acute or recurrent chronic intestinal infections, with active gastrointestinal bleeding or gastrointestinal stricture or intestinal obstruction, with severity coronary heart disease or heart failure or renal failure and liver failure or severe electrolyte metabolism disorder, with pregnant or lactating or metal diseases or refuse to colonoscopy examination. Central stratification and block randomization is achieved via a computer-generated random-sequence table by using R software. The participants will be assigned into one of four groups at a ratio of 1 : 1, and received a single 3 L dose of either PEG or 200ml dose of lactulose, 100ml lactulose combined with 1L PEG, 100ml lactulose combined with 2L PEG. The following parameters were then obtained: time of the first defecation, defecation frequency, the overall drink liquid volume, the taste of the preparation, the tolerance evaluation, the cleansing quality of the bowel preparations and adverse reaction.
- Conditions
- Colonoscopy
- Being tested
- 100 ml lactulose combined with 1 L PEG, 100 ml lactulose combined with 2 L PEG, 200 ml lactulose, 3 L Polyethylene glycol solution
- Keywords
- Polyethylene Glycols, Colonoscopy, Laxatives, Lactulose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100 ml lactulose combined with 1 L PEGDrug
Also called lactulose and 1 L PEG group
the participants were instructed to consume 100 ml lactulose combined with 1000 mL of PEG solution
100 ml lactulose combined with 2 L PEGDrug
Also called lactulose and 2 L PEG group
the participants were instructed to consume 100 ml lactulose combined with 2000 mL of PEG solution
200 ml lactuloseDrug
Also called lactulose group
the participants were instructed to consume 200 ml lactulose alone
3 L Polyethylene glycol solutionDrug
Also called control group, PEG group
the participants were instructed to consume 3000 mL of PEG solution
| Study group | Role | What they receive |
|---|---|---|
| 3 L Polyethylene glycol solution group | Active comparator | The participants were instructed to consume 3000 mL of PEG solution Receives: Drug: 3 L Polyethylene glycol solution |
| 100 ml lactulose combined with 1 L PEG group | Experimental | the participants were instructed to consume 100 ml lactulose combined with 1000 mL of PEG solution Receives: Drug: 100 ml lactulose combined with 1 L PEG |
| 100 ml lactulose combined with 2 L PEG group | Experimental | the participants were instructed to consume 100 ml lactulose combined with 2000 mL of PEG solution Receives: Drug: 100 ml lactulose combined with 2 L PEG |
| 200 ml lactulose group | Experimental | the participants were instructed to consume 200 ml lactulose Receives: Drug: 200 ml lactulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
The quality of bowel preparation
to assess the quality of bowel preparation by using Boston Bowel Preparation Scale. The minimum score value is 0，and the maximum value is 9. A higher score means a better outcome. Bowel cleansing was scored by the endoscopist performing the colonoscopy in the single-blind method.
Measured: up to 12 months
The preparation intolerance
to assess the preparation intolerance including the palatability of the bowel-cleansing agents, the general satisfaction with the bowel preparation, the willingness to perform another colonoscopy by using case report questionnaire. Moreover, the ratio of drink all preparation fluids and the specific amount of bowel preparation fluid are documented.
Measured: up to 12 months
Secondary outcomes (2)
The colorectal diseases detection rate
the cecal intubation time, colonoscopy perform time, and polyp detection rate or colorectal cancer detection rate are recorded.
Measured: up to 12 months
The adverse events
the adverse events including nausea, vomiting, abdominal pain, abdominal distension, and other adverse reactions after administration are evaluated.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start1 Sep 2021
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- More trials run by Sichuan UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Collaborators
- Affiliated Hospital of Southwest Medical University, Affiliated Hospital of North Sichuan Medical College
- Responsible party
- Principal investigator, Lin Cai, Sichuan University
- Investigators
- juan liao, PhD, Study director, West China Fourth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05076799
- Sponsor's protocol ID
- Sichuan U
- Status last verified
- Dec 2022
- First submitted
- 3 Sep 2021
- Last updated
- 3 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lactulose and/ or Polyethylene Glycol Solution for Bowel Preparation in Colonscopy: a Multi-center Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT05076799
- Acronym / sponsor ID
- Sichuan U
- Conditions
- Colonoscopy
- Keywords
- Polyethylene Glycols, Colonoscopy, Laxatives, Lactulose
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Collaborators
- Affiliated Hospital of Southwest Medical University, Affiliated Hospital of North Sichuan Medical College
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 13 Oct 2021 (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.
Colonoscopy is the most useful exam used to evaluate colorectal diseases, like colorectal polyps and cancer. The appropriate bowel preparation is indispensable for colonoscopy procedures. Polyethylene glycol solution (PEG) is the most frequent laxative medication. However, the taste is poor, and patients need to drink a lot of liquids to obtain adequate visualization of the mucosal surface. In fact, no laxative has all the characteristics of an ideal medication. Lactulose is an osmotic laxative which widely used in cirrhosis and constipation patients, and could inhibit bacterial in the colon to increase colon cleanliness and prolong the effect time of PEG. Previous study demonstrate PEG combined with lactulose has a significant improvement in the quality of bowel preparation compared with PEG alone. The present study aim to assess the efficacy of lactulose with or without PEG in bowel preparation to improve mucosal visualization, reduced volume of fluid consumed, and preparation intolerance.
Detailed description
This study will conduct in 5 clinical central. 1000 participants who were scheduled for colonoscopy age between 18 and 80 years were enrolled in the study. Exclusion criteria were patients with uncontrolled acute or recurrent chronic intestinal infections, with active gastrointestinal bleeding or gastrointestinal stricture or intestinal obstruction, with severity coronary heart disease or heart failure or renal failure and liver failure or severe electrolyte metabolism disorder, with pregnant or lactating or metal diseases or refuse to colonoscopy examination. Central stratification and block randomization is achieved via a computer-generated random-sequence table by using R software. The participants will be assigned into one of four groups at a ratio of 1 : 1, and received a single 3 L dose of either PEG or 200ml dose of lactulose, 100ml lactulose combined with 1L PEG, 100ml lactulose combined with 2L PEG. The following parameters were then obtained: time of the first defecation, defecation frequency, the overall drink liquid volume, the taste of the preparation, the tolerance evaluation, the cleansing quality of the bowel preparations and adverse reaction.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 3 L Polyethylene glycol solution group | Active comparator | Drug: 3 L Polyethylene glycol solutionThe participants were instructed to consume 3000 mL of PEG solution |
| 100 ml lactulose combined with 1 L PEG group | Experimental | Drug: 100 ml lactulose combined with 1 L PEGthe participants were instructed to consume 100 ml lactulose combined with 1000 mL of PEG solution |
| 100 ml lactulose combined with 2 L PEG group | Experimental | Drug: 100 ml lactulose combined with 2 L PEGthe participants were instructed to consume 100 ml lactulose combined with 2000 mL of PEG solution |
| 200 ml lactulose group | Experimental | Drug: 200 ml lactulosethe participants were instructed to consume 200 ml lactulose |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants who were scheduled for colonoscopy age between 18 and 80 years
Key exclusion criteria (4 listed)
- uncontrolled acute or recurrent chronic intestinal infections
- active gastrointestinal bleeding, gastrointestinal stricture, intestinal obstruction
- severe electrolyte metabolism disorder, severe coronary heart disease, heart failure, renal failure or liver failure
- pregnant, lactating, have metal diseases or refuse to colonoscopy examination
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 |
|---|---|---|
| 100 ml lactulose combined with 1 L PEGAlso: lactulose and 1 L PEG groupthe participants were instructed to consume 100 ml lactulose combined with 1000 mL of PEG solution | Drug | 100 ml lactulose combined with 1 L PEG group |
| 100 ml lactulose combined with 2 L PEGAlso: lactulose and 2 L PEG groupthe participants were instructed to consume 100 ml lactulose combined with 2000 mL of PEG solution | Drug | 100 ml lactulose combined with 2 L PEG group |
| 200 ml lactuloseAlso: lactulose groupthe participants were instructed to consume 200 ml lactulose alone | Drug | 200 ml lactulose group |
| 3 L Polyethylene glycol solutionAlso: control group, PEG groupthe participants were instructed to consume 3000 mL of PEG solution | Drug | 3 L Polyethylene glycol solution group |
Primary outcome
The quality of bowel preparation
Time frame: up to 12 months
to assess the quality of bowel preparation by using Boston Bowel Preparation Scale. The minimum score value is 0，and the maximum value is 9. A higher score means a better outcome. Bowel cleansing was scored by the endoscopist performing the colonoscopy in the single-blind method.
The preparation intolerance
Time frame: up to 12 months
to assess the preparation intolerance including the palatability of the bowel-cleansing agents, the general satisfaction with the bowel preparation, the willingness to perform another colonoscopy by using case report questionnaire. Moreover, the ratio of drink all preparation fluids and the specific amount of bowel preparation fluid are documented.
2 secondary outcomes
The colorectal diseases detection rate
Time frame: up to 12 months
The adverse events
Time frame: up to 12 months
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 3 Jan 2023.
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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.
juan liao, PhD study director
West China Fourth Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 100 ml lactulose combined with 1 L PEG, 100 ml lactulose combined with 2 L PEG and 200 ml lactulose in people with Colonoscopy, run by Sichuan University 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 4 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 3 Jan 2023. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The quality of bowel preparation (time frame: up to 12 months). The study lists 2 primary outcomes in all. 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 3 Jan 2023.