ColonoscopyNCT05379491
Application of Linaclotide Capsule in Bowel Preparation for Patients at High Risk of Inadequate Bowel Preparation
A study testing 3 L PEG + linaclotide in people with Colonoscopy, run by Zhiguo Liu at 8 sites in China.
Trial summary
The purpose of this study is to compare the colon cleansing quality of linaclotide versus control in adult patients at high risk of inadequate bowel preparation: one group will receive polyethylene glycol solution (PEG) split dose (1 L + 2 L) plus linaclotide and the other group PEG (1 L + 2 L) plus placebo before… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colonoscopy
- What is being tested?
- 3 L PEG + linaclotide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 720 participants
- Where
- 8 sitesChina
- Study dates
- 1 Aug 2022to 15 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- scheduled for colonoscopy
- age ≥ 18
- meet any of the followings: functional constipation according to Rome IV criteria, poor bowel preparation history, BMI > 25 kg/m2, age > 70, history of abdominal/pelvic surgery, comorbidity (diabetes, Parkinson's disease, stroke, or history of spinal cord injury), antidepressant usage, opioid usage
- willing to provide informed consent
Who cannot join
- unable to cooperate with questionnaires
- uncontrolled hypertension (systolic .170 mm Hg and diastolic.100mmHg)
- pregnancy or lactation
- toxic colitis, or megacolon
- allergy to preparation components
- active inflammatory bowel disease
Show all 15Show fewer
- clinically significant electrolyte abnormalities
- a history of severe renal, liver, or cardiac insufficiency
- has already been enrolled in the study
- gastrointestinal obstruction
- obvious gastroparesis or gastric retention
- bowel perforation
- polyp syndrome
- history of colectomy
- any other condition that is inappropriate for enrollment as judged by the investigator.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Linfen Central Hospital
Linfen, Shanxi, 041000
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi
Xi'an Central Hospital
Xi'an, Shaanxi, 710004
Xi'an Jiaotong University Second Affiliated Hospital
Xi'an, Shaanxi, 710004
Air Force 986 Hospital
Xi'an, Shaanxi, 710036
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, 710036
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, 710068
Ningxia Hui Autonomous Region People's Hospital
Yinchuan, Ningxia, 750002
About this study
Official title: An Efficacy and Safety Evaluation of Linaclotide in Bowel Preparation by Patients at High Risk of Inadequate Bowel Preparation: a Multicenter, Randomized, Double-Blind, Controlled Clinical Trial
The purpose of this study is to compare the colon cleansing quality of linaclotide versus control in adult patients at high risk of inadequate bowel preparation: one group will receive polyethylene glycol solution (PEG) split dose (1 L + 2 L) plus linaclotide and the other group PEG (1 L + 2 L) plus placebo before colonoscopy.
Read the detailed description
The objective of this trial is to compare the colon cleanliness achieved with PEG split dose (1 L + 2 L) + linaclotide versus PEG split dose (1 L + 2 L) + placebo for patients scheduled for a colonoscopy at high risk of inadequate bowel preparation. The target patients are those with constipation, poor bowel preparation history, history of abdominal/pelvic surgery, comorbidity (diabetes, Parkinson's disease, stroke, or history of spinal cord injury), BMI > 25 kg/m2, age > 70, tricyclic antidepressants usage, or opioid usage, as defined by the latest version of Bowel Preparation Guidelines.
- Conditions
- Colonoscopy
- Being tested
- 3 L PEG + linaclotide, 3 L PEG + placebo
- Keywords
- colonoscopy, inadequate bowel preparation, Boston Bowel Preparation Scale, linaclotide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 L PEG + linaclotideDrug
Participants take a linaclotide capsule on the day before colonoscopy at least 30 minutes before the first meal (if this is impossible, take the capsule as early as possible on that day). Participants take 1 L polyethylene glycol electrolyte solution within 1 hour from 8 p.m the night before the examination and take another linaclotide capsule and 2 L polyethylene glycol electrolyte solution 4 hours before the colonoscopy.
3 L PEG + placeboDrug
Participants take a placebo capsule on the day before colonoscopy at least 30 minutes before the first meal (if this is impossible, take the capsule as early as possible on that day). Participants take 1 L polyethylene glycol electrolyte solution within 1 hour from 8 p.m the night before the examination and take another placebo capsule and 2 L polyethylene glycol electrolyte solution 4 hours before the colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| 3 L PEG + Linaclotide | Active comparator | Bowel preparation for colonoscopy was performed with 3 L polyethylene glycol solution combined with 2-day linaclotide. Receives: Drug: 3 L PEG + linaclotide |
| 3 L PEG + Placebo | Placebo comparator | Bowel preparation for colonoscopy was performed with 3 L polyethylene glycol solution combined with 2-day placebo. Receives: Drug: 3 L PEG + placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel preparation adequate rate
The rate of participants with all colon segment scores (proximal colon, transverse colon, distal colon) are ≥ 2 according to Boston Bowel Preparation Scale.
Measured: 48 hours
Number of adenomas per patient
If there is no significant difference in the first primary outcome between the two groups, compare the average number of adenomas per patient detected by colonoscopy.
Measured: 48 hours
Secondary outcomes (7)
Subject willingness to repeat the preparation
Survey
Measured: 1 Day of colonoscopy
Tolerance to bowel preparation
It will be subjective and assessed as non, mild, moderate, severe.
Measured: 1 Day of colonoscopy
Tolerance to colonoscopy
It will be subjective and assessed as non, mild, moderate, severe.
Measured: 1 Day of colonoscopy
Average number of polyps per patient
Average number of polyps detected per patient by colonoscopy in each arm
Measured: 1 Day of colonoscopy
Average number of adenomas per patient
Average number of adenomas detected per patient by colonoscopy in each arm
Measured: 1 Day of colonoscopy
Withdrawal time
the time from cecal identification to the withdrawal of the colonoscopy across the anus minus the time of polypectomy.
Measured: 1Day of colonoscopy
Cecal intubation rate for colonoscopies
Cecal intubation was defined as reaching the ileocecal valve
Measured: 1 Day of colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start1 Aug 2022
- Primary completion30 Jun 2023
- Study completion15 Jul 2023
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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 720 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhiguo Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhiguo Liu, Xijing Hospital of Digestive Diseases
- Investigators
- Zhiguo Liu, M.D., Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05379491
- Sponsor's protocol ID
- KY20222119-F-1
- Status last verified
- May 2024
- First submitted
- 14 May 2022
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- 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 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Efficacy and Safety Evaluation of Linaclotide in Bowel Preparation by Patients at High Risk of Inadequate Bowel Preparation: a Multicenter, Randomized, Double-Blind, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05379491
- Acronym / sponsor ID
- KY20222119-F-1
- Conditions
- Colonoscopy
- Keywords
- colonoscopy, inadequate bowel preparation, Boston Bowel Preparation Scale, linaclotide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 720 participants (actual)
- Lead sponsor
- Zhiguo LiuUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 18 May 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 purpose of this study is to compare the colon cleansing quality of linaclotide versus control in adult patients at high risk of inadequate bowel preparation: one group will receive polyethylene glycol solution (PEG) split dose (1 L + 2 L) plus linaclotide and the other group PEG (1 L + 2 L) plus placebo before colonoscopy.
Detailed description
The objective of this trial is to compare the colon cleanliness achieved with PEG split dose (1 L + 2 L) + linaclotide versus PEG split dose (1 L + 2 L) + placebo for patients scheduled for a colonoscopy at high risk of inadequate bowel preparation. The target patients are those with constipation, poor bowel preparation history, history of abdominal/pelvic surgery, comorbidity (diabetes, Parkinson's disease, stroke, or history of spinal cord injury), BMI > 25 kg/m2, age > 70, tricyclic antidepressants usage, or opioid usage, as defined by the latest version of Bowel Preparation Guidelines.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 L PEG + Linaclotide | Active comparator | Drug: 3 L PEG + linaclotideBowel preparation for colonoscopy was performed with 3 L polyethylene glycol solution combined with 2-day linaclotide. |
| 3 L PEG + Placebo | Placebo comparator | Drug: 3 L PEG + placeboBowel preparation for colonoscopy was performed with 3 L polyethylene glycol solution combined with 2-day placebo. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- scheduled for colonoscopy
- age ≥ 18
- meet any of the followings: functional constipation according to Rome IV criteria, poor bowel preparation history, BMI > 25 kg/m2, age > 70, history of abdominal/pelvic surgery, comorbidity (diabetes, Parkinson's disease, stroke, or history of spinal cord injury), antidepressant usage, opioid usage
- willing to provide informed consent
Key exclusion criteria (15 listed)
- unable to cooperate with questionnaires
- uncontrolled hypertension (systolic .170 mm Hg and diastolic.100mmHg)
- pregnancy or lactation
- toxic colitis, or megacolon
- allergy to preparation components
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 L PEG + linaclotideParticipants take a linaclotide capsule on the day before colonoscopy at least 30 minutes before the first meal (if this is impossible, take the capsule as early as possible on that day). Participants take 1 L polyethylene glycol electrolyte solution within 1 hour from 8 p.m the night before the examination and take another linaclotide capsule and 2 L polyethylene glycol electrolyte solution 4 hours before the colonoscopy. | Drug | 3 L PEG + Linaclotide |
| 3 L PEG + placeboParticipants take a placebo capsule on the day before colonoscopy at least 30 minutes before the first meal (if this is impossible, take the capsule as early as possible on that day). Participants take 1 L polyethylene glycol electrolyte solution within 1 hour from 8 p.m the night before the examination and take another placebo capsule and 2 L polyethylene glycol electrolyte solution 4 hours before the colonoscopy. | Drug | 3 L PEG + Placebo |
Primary outcome
Bowel preparation adequate rate
Time frame: 48 hours
The rate of participants with all colon segment scores (proximal colon, transverse colon, distal colon) are ≥ 2 according to Boston Bowel Preparation Scale.
Number of adenomas per patient
Time frame: 48 hours
If there is no significant difference in the first primary outcome between the two groups, compare the average number of adenomas per patient detected by colonoscopy.
7 secondary outcomes
Subject willingness to repeat the preparation
Time frame: 1 Day of colonoscopy
Tolerance to bowel preparation
Time frame: 1 Day of colonoscopy
Tolerance to colonoscopy
Time frame: 1 Day of colonoscopy
Average number of polyps per patient
Time frame: 1 Day of colonoscopy
Average number of adenomas per patient
Time frame: 1 Day of colonoscopy
Withdrawal time
Time frame: 1Day of colonoscopy
Cecal intubation rate for colonoscopies
Time frame: 1 Day of colonoscopy
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 23 May 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.
Zhiguo Liu, M.D. principal investigator
Study Principal Investigator
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3 L PEG + linaclotide in people with Colonoscopy, run by Zhiguo Liu at 8 sites 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 4 inclusion and 15 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 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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. Some participants in this study may receive a placebo. 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: 48 hours). 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 23 May 2024.