IBDNCT05878639
Efficacy and Safety of Lactulose for Bowel Preparation in Patients With Inflammatory Bowel Disease
A study testing 3 bottles of Lactulose oral solution and 3L-polyethylene glycol in people with IBD, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the efficacy, safety and tolerability of lactulose in bowel preparation in IBD patients. The main question it aims to answer is: Does lactulose have better efficacy, safety and tolerability than 3L-PEG? Participants will be divided into PEG group or Lactulose group at a… Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- IBD
- What is being tested?
- 3 bottles of Lactulose oral solution and 3L-polyethylene glycol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 28 Mar 2023to 1 Jul 2023
- 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 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients with confirmed IBD or suspected IBD for at least 3 months, aged between 16-75 years and requiring a colonoscopy are invited to participate in our study. The diagnosis of IBD is based on recognized standards, including clinical symptoms, endoscopy, radiology, pathology and surgical history.
Who cannot join
- Patients are excluded if they (1) are clinical active UC and CD, (2) are known or suspected gastrointestinal obstruction, bowel perforation, toxic colitis or megacolon, recent or active gastrointestinal bleeding, (3) are congestive heart failure, severe renal failure, (4) are severe dehydration or electrolyte disturbances, (5) are pregnant, (6) are allergic to PEG or Lactulose, (7) are diabetics, (8) are lactose or galactose intolerance, (9) refuse to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
About this study
Official title: Evaluate Lactulose for Bowel Preparation in Patients With Inflammatory Bowel Disease
The goal of this clinical trial is to evaluate the efficacy, safety and tolerability of lactulose in bowel preparation in IBD patients. The main question it aims to answer is: Does lactulose have better efficacy, safety and tolerability than 3L-PEG? Participants will be divided into PEG group or Lactulose group at a 1:1 ratio by a random number method. Each patient will get a leaflet provided by hospital introducing bowel preparation methods and diet restriction before bowel preparation. They will have bowel preparation with different drugs according to group. The grade of bowel cleansing will be assessed through the Boston Bowel Preparation Scale (BBPS). The tolerability, satisfaction and safety of the two bowel preparation methods will be assessed through the patients self-administered questionnaires.
- Conditions
- IBD
- Being tested
- 3 bottles of Lactulose oral solution, 3L-polyethylene glycol
- Keywords
- colonoscopy, polyethylene glycol, IBD, bowel preparation, lactulose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 bottles of Lactulose oral solutionDrug
Patients will take lactulose for bowel preparation.
3L-polyethylene glycolDrug
Patients will take 3L-polyethylene glycol for bowel preparation.
| Study group | Role | What they receive |
|---|---|---|
| Patients take Lactulose for bowel preparation | Experimental | Patients take Lactulose for bowel preparation. Receives: Drug: 3 bottles of Lactulose oral solution |
| Patients take 3L-polyethylene glycol for bowel preparation | Active comparator | Patients take 3L-polyethylene glycol for bowel preparation
. Receives: Drug: 3L-polyethylene glycol |
What is being measured
The primary outcome is the main question the study is designed to answer.
effective preparation rate
Boston Bowel Preparation Scale (BBPS) >= 6 with a partial score >= 2 in each colon segment
Measured: 5 minutes before the colonoscopy ends
incidence of adverse events
incidence of adverse events in each group
Measured: 2 hours after having bowel preparation
taste score evaluated by patients
Five-point scale is used to evaluate taste (very bad, bad, moderate, good, very good)
Measured: 2 hours after having bowel preparation
Secondary outcomes (2)
effects of bowel preparation drugs on liver function
total protein, albumin, bilirubin, alanine aminotransferase
Measured: 2 hours after having bowel preparation
effects of bowel preparation drugs on serum electrolyte
sodium, potassium, chloride
Measured: 2 hours after having bowel preparation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start28 Mar 2023
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBDStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lin Daopo, Study director, Department of Gastroenterology, The Second Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05878639
- Sponsor's protocol ID
- SAHoWMU-CR2023-01-104
- Status last verified
- Jul 2023
- First submitted
- 10 May 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- 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 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate Lactulose for Bowel Preparation in Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT05878639
- Acronym / sponsor ID
- SAHoWMU-CR2023-01-104
- Conditions
- IBD
- Keywords
- colonoscopy, polyethylene glycol, IBD, bowel preparation, lactulose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 26 May 2023 (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.
The goal of this clinical trial is to evaluate the efficacy, safety and tolerability of lactulose in bowel preparation in IBD patients. The main question it aims to answer is: Does lactulose have better efficacy, safety and tolerability than 3L-PEG? Participants will be divided into PEG group or Lactulose group at a 1:1 ratio by a random number method. Each patient will get a leaflet provided by hospital introducing bowel preparation methods and diet restriction before bowel preparation. They will have bowel preparation with different drugs according to group. The grade of bowel cleansing will be assessed through the Boston Bowel Preparation Scale (BBPS). The tolerability, satisfaction and safety of the two bowel preparation methods will be assessed through the patients self-administered questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients take Lactulose for bowel preparation | Experimental | Drug: 3 bottles of Lactulose oral solutionPatients take Lactulose for bowel preparation. |
| Patients take 3L-polyethylene glycol for bowel preparation | Active comparator | Drug: 3L-polyethylene glycolPatients take 3L-polyethylene glycol for bowel preparation . |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with confirmed IBD or suspected IBD for at least 3 months, aged between 16-75 years and requiring a colonoscopy are invited to participate in our study. The diagnosis of IBD is based on recognized standards, including clinical symptoms, endoscopy, radiology, pathology and surgical history.
Key exclusion criteria (1 listed)
- Patients are excluded if they (1) are clinical active UC and CD, (2) are known or suspected gastrointestinal obstruction, bowel perforation, toxic colitis or megacolon, recent or active gastrointestinal bleeding, (3) are congestive heart failure, severe renal failure, (4) are severe dehydration or electrolyte disturbances, (5) are pregnant, (6) are allergic to PEG or Lactulose, (7) are diabetics, (8) are lactose or galactose intolerance, (9) refuse to participate in this study.
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 |
|---|---|---|
| 3 bottles of Lactulose oral solutionPatients will take lactulose for bowel preparation. | Drug | Patients take Lactulose for bowel preparation |
| 3L-polyethylene glycolPatients will take 3L-polyethylene glycol for bowel preparation. | Drug | Patients take 3L-polyethylene glycol for bowel preparation |
Primary outcome
effective preparation rate
Time frame: 5 minutes before the colonoscopy ends
Boston Bowel Preparation Scale (BBPS) >= 6 with a partial score >= 2 in each colon segment
incidence of adverse events
Time frame: 2 hours after having bowel preparation
incidence of adverse events in each group
taste score evaluated by patients
Time frame: 2 hours after having bowel preparation
Five-point scale is used to evaluate taste (very bad, bad, moderate, good, very good)
2 secondary outcomes
effects of bowel preparation drugs on liver function
Time frame: 2 hours after having bowel preparation
effects of bowel preparation drugs on serum electrolyte
Time frame: 2 hours after having bowel preparation
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 1 Aug 2023.
- 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.
Lin Daopo study director
Department of Gastroenterology, The Second Affiliated Hospital of Wenzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3 bottles of Lactulose oral solution and 3L-polyethylene glycol in people with IBD, run by Second Affiliated Hospital of Wenzhou Medical 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 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 1 Aug 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.
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?
effective preparation rate (time frame: 5 minutes before the colonoscopy ends). The study lists 3 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 1 Aug 2023.