Bowel Preparation for ColonoscopyNCT05291325
Application of Linaclotide Capsule in Bowel Preparation for Colonoscopy
A study testing 3L PEG + Linaclotide, 3L PEG and 2L PEG + Linaclotide in people with Bowel Preparation for Colonoscopy, run by Changhai Hospital at 1 site in China.
Trial summary
The clinical purpose of this study was to investigate whether the adjuvant application of linaclotide in bowel preparation for colonoscopy could improve the quality of bowel preparation or reduce the dosage of laxatives. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Bowel Preparation for Colonoscopy
- What is being tested?
- 3L PEG + Linaclotide, 3L PEG and 2L PEG + Linaclotide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,607 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2022to 28 Apr 2024
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-75 years old, male or female;
- To undergo diagnostic, screening or monitoring colonoscopy;
- Signed written informed consent;
Who cannot join
- Severe cardiopulmonary insufficiency, renal failure or a history of stroke or myocardial infarction within six months;
- History of abdominal or pelvic surgery;
- Pregnant and lactating women;
- BMI > 28, BMI < 18.5, inflammatory bowel disease, constipation (defecation less than 3 times in the last week, and laborious defecation, fecal sclerosis, low volume) or intestinal obstruction and other high-risk factors of intestinal preparation;
- Abnormal coagulation function or taking antiplatelet or anticoagulant drugs within 7 days;
- Warning symptoms and signs of colorectal cancer: hematochezia, melena, unexplained anemia, low body weight, abdominal mass, positive digital rectal test; or imaging and laboratory tests highly suspect colorectal cancer;
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- Colon polyps have been identified;
- Stow score 7 (watery, no solid mass), diarrhea was considered;
- Participation in other interventional clinical trials within 60 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of Linaclotide Capsule in Bowel Preparation for Colonoscopy: a Multicenter, Randomized, Controlled Clinical Study
The clinical purpose of this study was to investigate whether the adjuvant application of linaclotide in bowel preparation for colonoscopy could improve the quality of bowel preparation or reduce the dosage of laxatives.
- Conditions
- Bowel Preparation for Colonoscopy
- Being tested
- 3L PEG + Linaclotide, 3L PEG, 2L PEG + Linaclotide
- Keywords
- Linaclotide, Bowel preparation, colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3L PEG + LinaclotideDrug
Before colonoscopy, particpant take linaclotide capsules for 3 days (1 tablet should be taken at least 30 minutes before the first meal every day). Particpant take 1500ml polyethylene glycol electrolyte solution within 1.5 hours from 20 p.m the night before the examination; and repeat the same dose of polyethylene glycol electrolyte solution 4-6 hours before colonoscopy.
3L PEGDrug
Particpant take 1500ml polyethylene glycol electrolyte solution within 1.5 hours from 20 p.m the night before the examination; and repeat the same dose of polyethylene glycol electrolyte solution 4-6 hours before colonoscopy.
2L PEG + LinaclotideDrug
Before colonoscopy, particpant take linaclotide capsules for 3 days (1 tablet should be taken at least 30 minutes before the first meal every day). Particpant take 1000ml polyethylene glycol electrolyte solution within 1 hours from 20 p.m the night before the examination; and repeat the same dose of polyethylene glycol electrolyte solution 4-6 hours before colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| 3L PEG + Linaclotide | Experimental | Bowel preparation for colonoscopy was performed with 3L polyethylene glycol solution combined with 3-day linaclotide. Receives: Drug: 3L PEG + Linaclotide |
| 3L PEG alone | Active comparator | Bowel preparation for colonoscopy was performed with 3L polyethylene glycol solution without linaclotide. Receives: Drug: 3L PEG |
| 2L PEG + Linaclotide | Experimental | Bowel preparation for colonoscopy was performed with 2L polyethylene glycol solution combined with 3-day linaclotide. Receives: Drug: 2L PEG + Linaclotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel preparation adequate rate
The proportion of participants with all colon segment scores (right colon, transverse colon, left colon) were ≥ 2 according to Boston Bowel Preparation Scale (BBPS) .
Measured: within 10 minute after viewing colonoscopy video.
Secondary outcomes (10)
Boston bowel preparation scale score
The BBPS scoring rules: 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 are 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 is seen well; 3, entire mucosa of colon segment seen well, with no residual staining, small fragments of stool, or opaque liquid. the higher the score, the better the quality of bowel preparation. 3 intestinal segments were scored separately: the right side of the colon, the transverse section of the colon, and the left side of the colon. Total BBPS score 0-9, the higher the score, the better the quality of bowel preparation.
Measured: Within 10 minute after viewing colonoscopy video.
Aronchick Scale
Overall bowel preparation was scored prior to irrigation or suction. The Aronchick Scale scoring rules: 1, excellent, a small amount of liquid, 95% mucous membrane is visible; 2, good, plenty of clear fluid, covering 5%-25% of mucous membrane, 90% mucous membrane is visible; 3, medium, semi-solid manure that cannot be sucked out or washed away, 90% mucous membrane is visible; 4, poor, semi-solid manure that cannot be sucked out or washed away, 90% mucous membrane is visible; 5, inadequate, repeated bowel preparation or reexamination is required. Total Aronchick score 1-5, the lower the score, the better the quality of bowel preparation.
Measured: Within 10 minute after viewing colonoscopy video.
Bowel preparation excellent rate
The proportion of participants with total score ≥ 8 according to Boston Bowel Preparation Scale.
Measured: Within 10 minute after viewing colonoscopy video.
Bowel preparation completion rate assessed by questionnaire survey
Proportion of subjects with laxative intake greater than 90% of the required amount in protocol.
Measured: Immediately after questionnaire survey.
Subjects satisfaction rate assessed by questionnaire survey
Proportion of subjects satisfacted with the whole intestinal preparation process. Subjects satisfaction was divided into four grades: 4, very satisfied; 3, moderately satisfied; 2, moderately dissatisfied; 1, very dissatisfied. Subjects in grades 3 and 4 were considered satisfied; subjects in grades 1 and 2 were considered dissatisfied.
Measured: Immediately after questionnaire survey.
Endoscopists satisfaction with the quality of bowel preparation
Proportion of endoscopists satisfacted with the quality of bowel preparation during colonoscopy. Endoscopists satisfaction was divided into four grades: 4, very satisfied; 3, moderately satisfied; 2, moderately dissatisfied; 1, very dissatisfied. Subjects in grades 3 and 4 were considered satisfied; subjects in grades 1 and 2 were considered dissatisfied.
Measured: Immediately after colonoscopy.
Adenoma detection rate
The adenoma detection rate was calculated as the number of colonoscopies with at least one adenoma detected divided by the total number of colonoscopies in the group. Adenomatous polyps must be confirmed by pathological findings.
Measured: 14 days after colonosopy.
Polyp detection rate
The polyp detection rate was calculated as the number of colonoscopies with at least one polyp detected divided by the total number of colonoscopies in the group.
Measured: Immediately after colonoscopy.
Incidence of adverse events assessed by questionnaire survey
Proportion of subjects with adverse events occuring in intestinal preparation.
Measured: Immediately after questionnaire survey.
Drug compliance in linaclotide group
Proportion of subjects Taking 3 linaclotide capsules according to the protocol in linaclotide group.
Measured: Immediately after questionnaire survey.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start25 May 2022
- Primary completion30 Aug 2023
- Study completion28 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bowel Preparation for ColonoscopyStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,607 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanxi Provincial People's Hospital, 900th Hospital of PLA Joint Logistic Support Force, Ruijin Hospital, The First Affiliated Hospital of Nanchang University, Qilu Hospital of Shandong University, The Affiliated Hospital of Qingdao University, The Third Affiliated Hospital of Wenzhou Medical University, Affiliated Yueqing Hospital of Wenzhou Medical University, The First Affiliated Hospital of Soochow University, Seventh Medical Center of PLA Army General Hospital, The First Hospital of Jilin University, The Second Hospital of Hebei Medical University, The Affiliated Hospital of Inner Mongolia Medical University, The Second Affiliated Hospital of Dalian Medical University, General Hospital of Ningxia Medical University, Affiliated Hospital of Qinghai University, The First People's Hospital of Yunnan, Second Xiangya Hospital of Central South University, Shanghai Zhongshan Hospital, Daping Hospital of Army Medical University, Zunyi Medical College, Huizhou Municipal Central Hospital, Affiliated Hospital of Southwest Medical University, The First Affiliated Hospital of Shihezi University, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, The Second Affiliated Hospital of Air Force Military Medical University
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Zhaoshen Li, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291325
- Sponsor's protocol ID
- Linaclotide
- Status last verified
- Jun 2024
- First submitted
- 18 Mar 2022
- Last updated
- 20 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang M, Zou W, Xu C, Jia R, Liu K, Xu Q, Xu H. Polyethylene glycol combined with linaclotide is an effective and well-tolerated bowel preparation regimen for colonoscopy: an endoscopist-blinded, randomized, controlled trial. Eur J Gastroenterol Hepatol. 2021 Dec 1;33(1S Suppl 1):e625-e633. doi: 10.1097/MEG.0000000000002184.
PubMed 34034273Pan P, Chen H, Wang T, Liu K, Tuo B, Wang R, Fu H, Jiang C, Chen L, Zhao Q, Wang W, Chen W, Guo Q, Chen W, Li Y, Tian Z, Feng Z, Yang S, Fan Y, Luan F, Chen Y, Li Z, Bai Y. Effect of 3-Day Linaclotide Administration to Reduce the Polyethylene Glycol Volume for Colonoscopy Bowel Preparation: A Multicenter, Noninferiority, Randomized Controlled Trial. Am J Gastroenterol. 2026 Feb 1;121(2):453-460. doi: 10.14309/ajg.0000000000003557. Epub 2025 May 27.
PubMed 40423516
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Linaclotide Capsule in Bowel Preparation for Colonoscopy: a Multicenter, Randomized, Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT05291325
- Acronym / sponsor ID
- Linaclotide
- Conditions
- Bowel Preparation for Colonoscopy
- Keywords
- Linaclotide, Bowel preparation, colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,607 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- Shanxi Provincial People's Hospital, 900th Hospital of PLA Joint Logistic Support Force, Ruijin Hospital, The First Affiliated Hospital of Nanchang University, Qilu Hospital of Shandong University, The Affiliated Hospital of Qingdao University, The Third Affiliated Hospital of Wenzhou Medical University, Affiliated Yueqing Hospital of Wenzhou Medical University, The First Affiliated Hospital of Soochow University, Seventh Medical Center of PLA Army General Hospital, The First Hospital of Jilin University, The Second Hospital of Hebei Medical University, The Affiliated Hospital of Inner Mongolia Medical University, The Second Affiliated Hospital of Dalian Medical University, General Hospital of Ningxia Medical University, Affiliated Hospital of Qinghai University, The First People's Hospital of Yunnan, Second Xiangya Hospital of Central South University, Shanghai Zhongshan Hospital, Daping Hospital of Army Medical University, Zunyi Medical College, Huizhou Municipal Central Hospital, Affiliated Hospital of Southwest Medical University, The First Affiliated Hospital of Shihezi University, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, The Second Affiliated Hospital of Air Force Military Medical University
- Study start
- 25 May 2022 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 28 Apr 2024 (actual)
- First posted
- 22 Mar 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.
The clinical purpose of this study was to investigate whether the adjuvant application of linaclotide in bowel preparation for colonoscopy could improve the quality of bowel preparation or reduce the dosage of laxatives.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3L PEG + Linaclotide | Experimental | Drug: 3L PEG + LinaclotideBowel preparation for colonoscopy was performed with 3L polyethylene glycol solution combined with 3-day linaclotide. |
| 3L PEG alone | Active comparator | Drug: 3L PEGBowel preparation for colonoscopy was performed with 3L polyethylene glycol solution without linaclotide. |
| 2L PEG + Linaclotide | Experimental | Drug: 2L PEG + LinaclotideBowel preparation for colonoscopy was performed with 2L polyethylene glycol solution combined with 3-day linaclotide. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-75 years old, male or female;
- To undergo diagnostic, screening or monitoring colonoscopy;
- Signed written informed consent;
Key exclusion criteria (9 listed)
- Severe cardiopulmonary insufficiency, renal failure or a history of stroke or myocardial infarction within six months;
- History of abdominal or pelvic surgery;
- Pregnant and lactating women;
- BMI > 28, BMI < 18.5, inflammatory bowel disease, constipation (defecation less than 3 times in the last week, and laborious defecation, fecal sclerosis, low volume) or intestinal obstruction and other high-risk factors of intestinal preparation;
- Abnormal coagulation function or taking antiplatelet or anticoagulant drugs within 7 days;
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 |
|---|---|---|
| 3L PEG + LinaclotideBefore colonoscopy, particpant take linaclotide capsules for 3 days (1 tablet should be taken at least 30 minutes before the first meal every day). Particpant take 1500ml polyethylene glycol electrolyte solution within 1.5 hours from 20 p.m the night before the examination; and repeat the same dose of polyethylene glycol electrolyte solution 4-6 hours before colonoscopy. | Drug | 3L PEG + Linaclotide |
| 3L PEGParticpant take 1500ml polyethylene glycol electrolyte solution within 1.5 hours from 20 p.m the night before the examination; and repeat the same dose of polyethylene glycol electrolyte solution 4-6 hours before colonoscopy. | Drug | 3L PEG alone |
| 2L PEG + LinaclotideBefore colonoscopy, particpant take linaclotide capsules for 3 days (1 tablet should be taken at least 30 minutes before the first meal every day). Particpant take 1000ml polyethylene glycol electrolyte solution within 1 hours from 20 p.m the night before the examination; and repeat the same dose of polyethylene glycol electrolyte solution 4-6 hours before colonoscopy. | Drug | 2L PEG + Linaclotide |
Primary outcome
Bowel preparation adequate rate
Time frame: within 10 minute after viewing colonoscopy video.
The proportion of participants with all colon segment scores (right colon, transverse colon, left colon) were ≥ 2 according to Boston Bowel Preparation Scale (BBPS) .
10 secondary outcomes
Boston bowel preparation scale score
Time frame: Within 10 minute after viewing colonoscopy video.
Aronchick Scale
Time frame: Within 10 minute after viewing colonoscopy video.
Bowel preparation excellent rate
Time frame: Within 10 minute after viewing colonoscopy video.
Bowel preparation completion rate assessed by questionnaire survey
Time frame: Immediately after questionnaire survey.
Subjects satisfaction rate assessed by questionnaire survey
Time frame: Immediately after questionnaire survey.
Endoscopists satisfaction with the quality of bowel preparation
Time frame: Immediately after colonoscopy.
Adenoma detection rate
Time frame: 14 days after colonosopy.
Polyp detection rate
Time frame: Immediately after colonoscopy.
Incidence of adverse events assessed by questionnaire survey
Time frame: Immediately after questionnaire survey.
Drug compliance in linaclotide group
Time frame: Immediately after questionnaire survey.
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 20 Jun 2024.
- Background: PubMed 34034273Zhang M, Zou W, Xu C, Jia R, Liu K, Xu Q, Xu H. Polyethylene glycol combined with linaclotide is an effective and well-tolerated bowel preparation regimen for colonoscopy: an endoscopist-blinded, randomized, controlled trial. Eur J Gastroenterol Hepatol. 2021 Dec 1;33(1S Suppl 1):e625-e633. doi: 10.1097/MEG.0000000000002184.
- Derived from this study: PubMed 40423516Pan P, Chen H, Wang T, Liu K, Tuo B, Wang R, Fu H, Jiang C, Chen L, Zhao Q, Wang W, Chen W, Guo Q, Chen W, Li Y, Tian Z, Feng Z, Yang S, Fan Y, Luan F, Chen Y, Li Z, Bai Y. Effect of 3-Day Linaclotide Administration to Reduce the Polyethylene Glycol Volume for Colonoscopy Bowel Preparation: A Multicenter, Noninferiority, Randomized Controlled Trial. Am J Gastroenterol. 2026 Feb 1;121(2):453-460. doi: 10.14309/ajg.0000000000003557. Epub 2025 May 27.
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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.
Zhaoshen Li principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3L PEG + Linaclotide, 3L PEG and 2L PEG + Linaclotide in people with Bowel Preparation for Colonoscopy, run by Changhai Hospital 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 3 inclusion and 9 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 20 Jun 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.
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 adequate rate (time frame: within 10 minute after viewing colonoscopy video.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05291325, which also lists 2 linked publications.
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 20 Jun 2024.