Bowel PreparationNCT05137145
Effect and Safety of Polyethylene Glycol Combined With Linaclotide on Colon Cleansing for Patients With Chronic Constipation
A study testing Linaclotide and Compound Polyethylene Glycol Electrolyte Powder in people with Bowel Preparation, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site in China.
Trial summary
Constipation is a common reason of poor bowel preparation, which negatively influences the quality of colonoscopy. Clinically to explore more effective and tolerant bowel clearance programs is necessary for patients with chronic constipation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bowel Preparation
- What is being tested?
- Linaclotide and Compound Polyethylene Glycol Electrolyte Powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 30 Apr 2022
- 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
- Inclusion criteria included: The inclusion criteria were patients ≥18 years old suffering from≥2 of the following criteria of chronic constipation under the Rome IV standard: straining, hard stool, residual stool feeling, occlusion feeling, manual bowel movement(BM) performed ≥25% of overall BMs, and BM frequency<3 times a week . A chronic status was defined as symptoms being present for at least six months, with the symptoms described above being present for at least three months.
Who cannot join
- Exclusion criteria included: (1)age <18 or> 75; (2) severe chronic renal failure, severe congestive heart failure and Liver dysfunction ;(3)with uncontrolled hypertension, diabetes, intestinal obstruction, intestinal perforation and electrolyte disorders, inflammatory intestinal disease and other organic gastrointestinal diseases;(4)with neurologic, endocrine, or metabolic disorders;(5)treatment with other gastrointestinal drivers, laxatives, and antilaxatives within nearly 2 weeks;(6)history of colorectal surgery;(7) dysphagia; (8) compromised swallowing reflex or mental status;(9)with consciousness disorders or examination intolerance;(10)pregnancy or lactation;(11)allergic to the drug composition;(12)Suspected history of alcohol or substance abuse; (13)Recent participants in clinical trials; (14) unable to give informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The second affiliated hospital of xi'an jiaotong university
Xi'an, Shaanxi, 710004
Fei Dai, MD, 13772151298, daifei68@hotmail.com
lianli wang, 15737939767, 15737939767@163.com
About this study
Official title: Effect and Safety of Polyethylene Glycol Combined With Linaclotide on Colon Cleansing Before Colonoscopy in Patients With Chronic Constipation:an Endoscopist-blinded,Randomized,Controlled, Multicentre Trial
Constipation is a common reason of poor bowel preparation, which negatively influences the quality of colonoscopy. Clinically to explore more effective and tolerant bowel clearance programs is necessary for patients with chronic constipation.
Read the detailed description
Colonoscopy is an important method to screen, diagnose and treat colon lesions. The quality of bowel preparation is requisite for the accuracy of diagnosis and safety of treatment. To explore the application effect and safety of Linaclotide combined with Compound Polyethylene Glycol Electrolyte Powder on colon cleansing before colonoscopy in patients with chronic constipation. A prospective mult-centers, colonoscopist-blinded study was conducted. A total of 300 patients with constipation who underwent colonoscopy in 8 hospitals from July to December 2021 were selected as study subjects and divided into the control group, observation group 1, observation group 2 and observation group 3 by random number table method, with 75 cases in each group. Intestinal cleanliness and the incidence of adverse reactions of patients in each group were compared.
- Conditions
- Bowel Preparation
- Being tested
- Linaclotide, Compound Polyethylene Glycol Electrolyte Powder
- Keywords
- Chronic Constipation, Colonoscopy, Linaclotide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LinaclotideDrug
The observation group 1 was given Linaclotide in 1 day combined with 4L of Compound Polyethylene Glycol Electrolyte Powder to clear the intestine, and the observation group 2 was given Linaclotide in 1 day combined with 4L of Compound Polyethylene Glycol Electrolyte Powder to clear the intestine. observation group 3 was given Linaclotide in 3 day combined with 3L of Compound Polyethylene Glycol Electrolyte Powder to clear the intestine. Intestinal cleanliness and the incidence of adverse reactions of patients in each group were compared.
Compound Polyethylene Glycol Electrolyte PowderDrug
The control group was given Compound Polyethylene Glycol Electrolyte Powder to clear the intestines,
| Study group | Role | What they receive |
|---|---|---|
| The control group | Experimental | The control group was given 4L of Compound Polyethylene Glycol Electrolyte Powder to clear the intestines Receives: Drug: Compound Polyethylene Glycol Electrolyte Powder |
| the observation group 1 | Experimental | the observation group 1 was given Linaclotide(290 ug) in 1 day combined with 4L of Compound Polyethylene Glycol Electrolyte Powder to clear the intestine Receives: Drug: Linaclotide; Drug: Compound Polyethylene Glycol Electrolyte Powder |
| the observation group 2 | Experimental | the observation group 2 was given Linaclotide(290 ug) in 1 day combined with 4L of Compound Polyethylene Glycol Electrolyte Powder to clear the intestine Receives: Drug: Linaclotide; Drug: Compound Polyethylene Glycol Electrolyte Powder |
| the observation group 3 | Experimental | the observation group 3 was given Linaclotide(290 ug) in 3 day combined with 3L of Compound Polyethylene Glycol Electrolyte Powder to clear the intestine. Receives: Drug: Linaclotide; Drug: Compound Polyethylene Glycol Electrolyte Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Boston Bowel Preparation Scale
the effect of colon cleansing
Measured: colonoscopy screening procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start1 Sep 2021
- Primary completion31 Mar 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bowel PreparationStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05137145
- Sponsor's protocol ID
- 2021030
- Status last verified
- Nov 2021
- First submitted
- 16 Nov 2021
- Last updated
- 30 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wang L, Zhang Y, Li J, Ran Y, Wang X, Ma X, Yang Q, Wang F, Hu J, Zhuang K, Wang J, Quan X, Wang S, Meng R, Chen Y, Li X, Song Y, Han S, Hu H, Li L, Dai F. Efficacy of Polyethylene Glycol Electrolyte Powder Combined With Linaclotide for Colon Cleansing in Patients With Chronic Constipation Undergoing Colonoscopy: A Multicenter, Single-Blinded, Randomized Controlled Trial. Clin Transl Gastroenterol. 2024 Jun 1;15(6):e1. doi: 10.14309/ctg.0000000000000708.
PubMed 38713137
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect and Safety of Polyethylene Glycol Combined With Linaclotide on Colon Cleansing Before Colonoscopy in Patients With Chronic Constipation:an Endoscopist-blinded,Randomized,Controlled, Multicentre Trial
- ClinicalTrials.gov ID
- NCT05137145
- Acronym / sponsor ID
- 2021030
- Conditions
- Bowel Preparation
- Keywords
- Chronic Constipation, Colonoscopy, Linaclotide
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 30 Nov 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.
Constipation is a common reason of poor bowel preparation, which negatively influences the quality of colonoscopy. Clinically to explore more effective and tolerant bowel clearance programs is necessary for patients with chronic constipation.
Detailed description
Colonoscopy is an important method to screen, diagnose and treat colon lesions. The quality of bowel preparation is requisite for the accuracy of diagnosis and safety of treatment. To explore the application effect and safety of Linaclotide combined with Compound Polyethylene Glycol Electrolyte Powder on colon cleansing before colonoscopy in patients with chronic constipation. A prospective mult-centers, colonoscopist-blinded study was conducted. A total of 300 patients with constipation who underwent colonoscopy in 8 hospitals from July to December 2021 were selected as study subjects and divided into the control group, observation group 1, observation group 2 and observation group 3 by random number table method, with 75 cases in each group. Intestinal cleanliness and the incidence of adverse reactions of patients in each group were compared.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| The control group | Experimental | Drug: Compound Polyethylene Glycol Electrolyte PowderThe control group was given 4L of Compound Polyethylene Glycol Electrolyte Powder to clear the intestines |
| the observation group 1 | Experimental | Drug: Linaclotide, Drug: Compound Polyethylene Glycol Electrolyte Powderthe observation group 1 was given Linaclotide(290 ug) in 1 day combined with 4L of Compound Polyethylene Glycol Electrolyte Powder to clear the intestine |
| the observation group 2 | Experimental | Drug: Linaclotide, Drug: Compound Polyethylene Glycol Electrolyte Powderthe observation group 2 was given Linaclotide(290 ug) in 1 day combined with 4L of Compound Polyethylene Glycol Electrolyte Powder to clear the intestine |
| the observation group 3 | Experimental | Drug: Linaclotide, Drug: Compound Polyethylene Glycol Electrolyte Powderthe observation group 3 was given Linaclotide(290 ug) in 3 day combined with 3L of Compound Polyethylene Glycol Electrolyte Powder to clear the intestine. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria included: The inclusion criteria were patients ≥18 years old suffering from≥2 of the following criteria of chronic constipation under the Rome IV standard: straining, hard stool, residual stool feeling, occlusion feeling, manual bowel movement(BM) performed ≥25% of overall BMs, and BM frequency<3 times a week . A chronic status was defined as symptoms being present for at least six months, with the symptoms described above being present for at least three months.
Key exclusion criteria (1 listed)
- Exclusion criteria included: (1)age <18 or> 75; (2) severe chronic renal failure, severe congestive heart failure and Liver dysfunction ;(3)with uncontrolled hypertension, diabetes, intestinal obstruction, intestinal perforation and electrolyte disorders, inflammatory intestinal disease and other organic gastrointestinal diseases;(4)with neurologic, endocrine, or metabolic disorders;(5)treatment with other gastrointestinal drivers, laxatives, and antilaxatives within nearly 2 weeks;(6)history of colorectal surgery;(7) dysphagia; (8) compromised swallowing reflex or mental status;(9)with consciousness disorders or examination intolerance;(10)pregnancy or lactation;(11)allergic to the drug composition;(12)Suspected history of alcohol or substance abuse; (13)Recent participants in clinical trials; (14) unable to give informed consent.
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 |
|---|---|---|
| LinaclotideThe observation group 1 was given Linaclotide in 1 day combined with 4L of Compound Polyethylene Glycol Electrolyte Powder to clear the intestine, and the observation group 2 was given Linaclotide in 1 day combined with 4L of Compound Polyethylene Glycol Electrolyte Powder to clear the intestine. observation group 3 was given Linaclotide in 3 day combined with 3L of Compound Polyethylene Glycol Electrolyte Powder to clear the intestine. Intestinal cleanliness and the incidence of adverse reactions of patients in each group were compared. | Drug | the observation group 1, the observation group 2, the observation group 3 |
| Compound Polyethylene Glycol Electrolyte PowderThe control group was given Compound Polyethylene Glycol Electrolyte Powder to clear the intestines, | Drug | The control group, the observation group 1, the observation group 2, the observation group 3 |
Primary outcome
The Boston Bowel Preparation Scale
Time frame: colonoscopy screening procedure
the effect of colon cleansing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Derived from this study: PubMed 38713137Wang L, Zhang Y, Li J, Ran Y, Wang X, Ma X, Yang Q, Wang F, Hu J, Zhuang K, Wang J, Quan X, Wang S, Meng R, Chen Y, Li X, Song Y, Han S, Hu H, Li L, Dai F. Efficacy of Polyethylene Glycol Electrolyte Powder Combined With Linaclotide for Colon Cleansing in Patients With Chronic Constipation Undergoing Colonoscopy: A Multicenter, Single-Blinded, Randomized Controlled Trial. Clin Transl Gastroenterol. 2024 Jun 1;15(6):e1. doi: 10.14309/ctg.0000000000000708.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Linaclotide and Compound Polyethylene Glycol Electrolyte Powder in people with Bowel Preparation, run by Second Affiliated Hospital of Xi'an Jiaotong 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: status not confirmed, as of the sponsor's last update on 30 Nov 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact fei dai, MD (13772151298, daifei68@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Boston Bowel Preparation Scale (time frame: colonoscopy screening procedure). 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 NCT05137145, which also lists 1 linked publication.
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 30 Nov 2021.