LactulosePhase 4NCT06748638
Clinical Study on the Application of Lactulose Combined with Linaclotide in Bowel Preparation for Colonoscopy
A Phase 4 study testing Lactulose, Lactulose+ linaclotide and polyethylene glycol (PEG) in people with Lactulose and Bowel Preparation, run by Haifeng Lan at 1 site in China.
Trial summary
This is a single-center, single-blind, randomized controlled clinical study. Participants meeting the inclusion criteria were randomly assigned to lactulose + linaclotide group, lactulose group, and PEG group in equal proportion. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lactulose, Bowel Preparation
- What is being tested?
- Lactulose, Lactulose+ linaclotide and polyethylene glycol (PEG)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 444 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 1 Oct 2025
- Phase
- Phase 4
- 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
Inclusion Criteria:Participants must meet all of the following criteria to enter the trial.
- Signed written informed consent;
- Age 18-80 years old, gender is not limited;
- The subjects could follow the follow-up plan, objectively describe the symptoms, and cooperate with the completion of the scale;
- Non-lactating pregnant women and no pregnancy plan during the test;
- Do not participate in any clinical trials for 3 months before and during the trial;
Exclusion Criteria: Subjects must exclude all of the following conditions to enter the study.
- Presence of any contraindications to colonoscopy (gastrointestinal obstruction or perforation, severe acute inflammatory bowel disease, toxic megacolon, severe heart failure, renal failure, or liver failure, etc.)
- Patients with galactosemia;
- Pregnancy or lactation;
- Allergic to intestinal preparation drugs;
- Termination of the experiment for any other reason.
Trial locations and contacts
1 site in 1 country.
About this study
This is a single-center, single-blind, randomized controlled clinical study. Participants meeting the inclusion criteria were randomly assigned to lactulose + linaclotide group, lactulose group, and PEG group in equal proportion.
In this study, the effectiveness, tolerability, adverse reactions and prognosis of three intestinal preparation regimens: lactulose -linalotide group, lactulose group and PEG group were compared by evaluating the intestinal cleanliness rate (BBPS score) of patients and quantitative analysis of intestinal bubble under colonoscopy, with a view to improving the intestinal cleanliness rate of colonoscopy subjects.
Read the detailed description
- Research program design This study was designed as a single-center, single-blind, randomized controlled clinical study.
- Entry criteria Patients aged ≥18 years and ≤80 years who need intestinal preparation before colonoscopy.
- Study sample size In this study, PASS 15 software was used to estimate the sample size. According to previous research data, the intestinal cleanliness rates of lactulose group (experimental group 1), lactulose + linalotide group (experimental group 2) and PEG group (control group) were set to be 86%, 90% and 69.36%, respectively, and the differences between the two experimental groups and the control group were mainly compared in this study. The bilateral test level for both tests was set as α=0.025, and the degree of assurance was 80%, which was allocated in an equal ratio of 1:1:1. Considering that there may be a 20% shedding rate, 148 patients were planned to be included in each group, and a total of 444 patients were to be included.
- Number of cases The total number of cases was 444, 148 in each group.
- Case selection 1) Inclusion criteria: ① Sign a written informed consent; Age 18-80 years old, gender is not limited; (3) The subjects could follow the follow-up plan, objectively describe the symptoms, and cooperate with the completion of the scale; (4) Non-lactating pregnant women and no pregnancy plan during the test;
- Do not participate in any clinical trials for 3 months before and during the trial; 2) Exclusion criteria: ①Presence of any contraindications to colonoscopy (gastrointestinal obstruction or perforation, severe acute inflammatory bowel disease, toxic megacolon, severe heart failure, renal failure, or liver failure, etc.) ② Galactosemia patients; ③Pregnancy or lactation; ④ Allergic to intestinal preparation drugs;
- Termination of the experiment for any other reason.
- Observation index
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- Main outcome measures: Patients' intestinal cleanliness rate (BBPS score)
- Secondary outcome measures
- The number of bubbles in the colonoscopy cavity;
- polyp detection rate (PDR) and Adenoma detection rate (ADR);
- Subjects' satisfaction;
- subject tolerance; (5) Intestinal preparation completion rate;
- Amount of exercise during intestinal preparation;
- Colonoscopy operation time;
- Incidence of adverse reactions; ⑨ Whether to have a colonoscopy for the first time; ⑩ The main indications of colonoscopy; ⑪ Willingness to conduct intestinal preparation; ⑫ Sleep quality. 7.Preparation before treatment: 1 or 3 days before colonoscopy, all the three groups were forbidden to eat high-fiber vegetables, dragon fruit and other seeded fruits, and should mainly eat low-fiber and low-residue foods, and eat dinner before 18:00, and then fast; Check for semi-liquid or liquid food the night before, and check for fasting and no drinking on the day. 8.Post-treatment: To replace fluid loss during the examination, the patient then drinks an adequate amount of fluid to maintain adequate hydration. Seek medical attention if severe or persistent diarrhea occurs. 9.Security assessment: The main adverse reactions were recorded as nausea, vomiting, abdominal distension and abdominal pain.
- Conditions
- Lactulose, Bowel Preparation
- Being tested
- Lactulose, Lactulose+ linaclotide, polyethylene glycol (PEG)
- Keywords
- Lactulose, Linaclotide, bowel preparation, colonoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LactuloseDrug
At 20:00 the night before the examination, pour 2 boxes of lactilose into a cup, add 1000ml of water and drink it; 4 to 6 hours before the examination, dissolve the third box of lactulose into 1000ml water, and drink it; Until pale yellow or clear dung water is drawn.
Lactulose+ linaclotideDrug
1 capsule of linalotide (290ug) taken orally half an hour before meal at 12:00 noon on the previous day， and two doses were taken after 20:00 according to the above Lactulose-taking method.
polyethylene glycol (PEG)Drug
a bag of PEG was dissolved into 1L at 20:00 1d before the examination, and was drunk at a constant rate within 2h; 4 to 6 hours before the inspection, dissolve the second bag of PEG into 2L water and drink it.
| Study group | Role | What they receive |
|---|---|---|
| Lactulose group ( group 1) | Experimental | lactulose oral solution, Duphalac, 15ml/ bag, 6 bags/box Receives: Drug: Lactulose |
| Lactulose + linaclotide group（group 2） | Experimental | Lactulose+ linaclotide 290μg (linaclotide capsule, Lingzeshu, 290ug/ capsule, 7 capsules/box) : Receives: Drug: Lactulose+ linaclotide |
| 3L PEG group（group 3） | Experimental | Polyethylene Glycol （PEG）：Heshuang, 137.15g/ bag ， Receives: Drug: polyethylene glycol (PEG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel preparation quality
The proportion of subjects with an overall Boston score ≥6 and a colon score ≥2 for each segment was considered valid.
The Boston bowel preparation scale (BBPS) can be used to evaluate indicators such as the volume, shape and mucosal clarity of stool and fluid in the bowel. The scoring criteria are as follows: 0 score: uncleared stool in the colon with indistinct mucosa, most commonly in the stage without bowel preparation; 1: Part of the intestinal mucosa was clearly displayed, while the other part of the mucosa was not clearly displayed due to feces and opaque liquid residues; 2 points: There is a small amount of stool and opaque liquid remaining in the colon; 3 points: All mucous membranes are clearly displayed, and no stool or opaque fluid remains in the colon. Rating description:
- The colon score of each segment was 0~3, and the total score was 0~9. ② The colon score of each segment was ≥2 points, indicating adequate intestinal preparation; ③ The total score of 6 and the score o
Measured: 1 day of scheduled colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start1 Sep 2024
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LactuloseStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 444 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haifeng Lan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Haifeng Lan, Nanjing Medical University
- Investigators
- Ji Xuan, Study director, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06748638
- Sponsor's protocol ID
- DZQH-KYLL-24-35
- Status last verified
- Sep 2024
- First submitted
- 13 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Application of Lactulose Combined with Linaclotide in Bowel Preparation for Colonoscopy
- ClinicalTrials.gov ID
- NCT06748638
- Acronym / sponsor ID
- DZQH-KYLL-24-35
- Conditions
- Lactulose, Bowel Preparation
- Keywords
- Lactulose, Linaclotide, bowel preparation, colonoscope
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 444 participants (estimated)
- Lead sponsor
- Haifeng LanUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 27 Dec 2024 (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.
This is a single-center, single-blind, randomized controlled clinical study. Participants meeting the inclusion criteria were randomly assigned to lactulose + linaclotide group, lactulose group, and PEG group in equal proportion.
In this study, the effectiveness, tolerability, adverse reactions and prognosis of three intestinal preparation regimens: lactulose -linalotide group, lactulose group and PEG group were compared by evaluating the intestinal cleanliness rate (BBPS score) of patients and quantitative analysis of intestinal bubble under colonoscopy, with a view to improving the intestinal cleanliness rate of colonoscopy subjects.
Detailed description
- Research program design This study was designed as a single-center, single-blind, randomized controlled clinical study.
- Entry criteria Patients aged ≥18 years and ≤80 years who need intestinal preparation before colonoscopy.
- Study sample size In this study, PASS 15 software was used to estimate the sample size. According to previous research data, the intestinal cleanliness rates of lactulose group (experimental group 1), lactulose + linalotide group (experimental group 2) and PEG group (control group) were set to be 86%, 90% and 69.36%, respectively, and the differences between the two experimental groups and the control group were mainly compared in this study. The bilateral test level for both tests was set as α=0.025, and the degree of assurance was 80%, which was allocated in an equal ratio of 1:1:1. Considering that there may be a 20% shedding rate, 148 patients were planned to be included in each group, and a total of 444 patients were to be included.
- Number of cases The total number of cases was 444, 148 in each group.
- Case selection 1) Inclusion criteria: ① Sign a written informed consent; Age 18-80 years old, gender is not limited; (3) The subjects could follow the follow-up plan, objectively describe the symptoms, and cooperate with the completion of the scale; (4) Non-lactating pregnant women and no pregnancy plan during the test;
- Do not participate in any clinical trials for 3 months before and during the trial; 2) Exclusion criteria: ①Presence of any contraindications to colonoscopy (gastrointestinal obstruction or perforation, severe acute inflammatory bowel disease, toxic megacolon, severe heart failure, renal failure, or liver failure, etc.) ② Galactosemia patients; ③Pregnancy or lactation; ④ Allergic to intestinal preparation drugs;
- Termination of the experiment for any other reason.
- Observation index
<!-- -->
- Main outcome measures: Patients' intestinal cleanliness rate (BBPS score)
- Secondary outcome measures
- The number of bubbles in the colonoscopy cavity;
- polyp detection rate (PDR) and Adenoma detection rate (ADR);
- Subjects' satisfaction;
- subject tolerance; (5) Intestinal preparation completion rate;
- Amount of exercise during intestinal preparation;
- Colonoscopy operation time;
- Incidence of adverse reactions; ⑨ Whether to have a colonoscopy for the first time; ⑩ The main indications of colonoscopy; ⑪ Willingness to conduct intestinal preparation; ⑫ Sleep quality. 7.Preparation before treatment: 1 or 3 days before colonoscopy, all the three groups were forbidden to eat high-fiber vegetables, dragon fruit and other seeded fruits, and should mainly eat low-fiber and low-residue foods, and eat dinner before 18:00, and then fast; Check for semi-liquid or liquid food the night before, and check for fasting and no drinking on the day. 8.Post-treatment: To replace fluid loss during the examination, the patient then drinks an adequate amount of fluid to maintain adequate hydration. Seek medical attention if severe or persistent diarrhea occurs. 9.Security assessment: The main adverse reactions were recorded as nausea, vomiting, abdominal distension and abdominal pain.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lactulose group ( group 1) | Experimental | Drug: Lactuloselactulose oral solution, Duphalac, 15ml/ bag, 6 bags/box |
| Lactulose + linaclotide group（group 2） | Experimental | Drug: Lactulose+ linaclotideLactulose+ linaclotide 290μg (linaclotide capsule, Lingzeshu, 290ug/ capsule, 7 capsules/box) : |
| 3L PEG group（group 3） | Experimental | Drug: polyethylene glycol (PEG)Polyethylene Glycol （PEG）：Heshuang, 137.15g/ bag ， |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| LactuloseAt 20:00 the night before the examination, pour 2 boxes of lactilose into a cup, add 1000ml of water and drink it; 4 to 6 hours before the examination, dissolve the third box of lactulose into 1000ml water, and drink it; Until pale yellow or clear dung water is drawn. | Drug | Lactulose group ( group 1) |
| Lactulose+ linaclotide1 capsule of linalotide (290ug) taken orally half an hour before meal at 12:00 noon on the previous day， and two doses were taken after 20:00 according to the above Lactulose-taking method. | Drug | Lactulose + linaclotide group（group 2） |
| polyethylene glycol (PEG)a bag of PEG was dissolved into 1L at 20:00 1d before the examination, and was drunk at a constant rate within 2h; 4 to 6 hours before the inspection, dissolve the second bag of PEG into 2L water and drink it. | Drug | 3L PEG group（group 3） |
Primary outcome
Bowel preparation quality
Time frame: 1 day of scheduled colonoscopy
The proportion of subjects with an overall Boston score ≥6 and a colon score ≥2 for each segment was considered valid. The Boston bowel preparation scale (BBPS) can be used to evaluate indicators such as the volume, shape and mucosal clarity of stool and fluid in the bowel. The scoring criteria are as follows: 0 score: uncleared stool in the colon with indistinct mucosa, most commonly in the stage without bowel preparation; 1: Part of the intestinal mucosa was clearly displayed, while the other part of the mucosa was not clearly displayed due to feces and opaque liquid residues; 2 points: There is a small amount of stool and opaque liquid remaining in the colon; 3 points: All mucous membranes are clearly displayed, and no stool or opaque fluid remains in the colon. Rating description: * The colon score of each segment was 0~3, and the total score was 0~9. ② The colon score of each segment was ≥2 points, indicating adequate intestinal preparation; ③ The total score of 6 and the score o
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Ji Xuan study director
Jinling Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lactulose, Lactulose+ linaclotide and polyethylene glycol (PEG) in people with Lactulose and Bowel Preparation, run by Haifeng Lan 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?
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: status not confirmed, as of the sponsor's last update on 27 Dec 2024. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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 quality (time frame: 1 day of scheduled colonoscopy). 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 27 Dec 2024.