IBD (Inflammatory Bowel Disease)NCT07335705
Analysis of Factors Influencing the Quality of Bowel Preparation Before Colonoscopy in IBD Patients
An observational study of IBD (Inflammatory Bowel Disease) and Colonoscopy, run by Changhai Hospital at 1 site in China.
Trial summary
The primary objectives of this project are twofold. On the one hand, it aims to investigate the current status of bowel preparation protocols and their quality in IBD patients undergoing colonoscopy, particularly focusing on the implementation of these protocols across hospitals following the release of the 2023 bowel… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- IBD (Inflammatory Bowel Disease), Colonoscopy, Colonoscopy: Bowel Preparation
- What is being tested?
- Standard Pre-colonoscopy Bowel Preparation Protocol
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 8 Dec 2025to 1 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: adult patients (aged ≥18 years) diagnosed with Inflammatory Bowel Disease (IBD) according to the 2023 Chinese guidelines, who are scheduled to undergo a colonoscopy
Who may be able to join
- Patients aged 18 years or older, of any gender, scheduled for colonoscopy;
- Patients diagnosed with Inflammatory Bowel Disease (IBD) according to the 2023 edition of the Guidelines for the Diagnosis and Treatment of Inflammatory Bowel Disease;
- Voluntary participation in this study and provision of signed informed consent.
Who cannot join
- History of acute myocardial infarction (within the past 6 months), severe cardiac, hepatic, or renal insufficiency, or psychiatric disorders;
- Current use of anticoagulants (e.g., aspirin, warfarin) or presence of coagulation disorders;
- Pregnant or lactating women;
- Acute intestinal infection within the past 2 weeks;
- History of colorectal tumors, familial adenomatous polyposis, or Peutz-Jeghers syndrome;
- History of intestinal obstruction, perforation, stenosis, or any other condition preventing completion of the examination;
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- Severe hearing impairment, cognitive dysfunction, or inability to cooperate with the survey;
- Individuals already enrolled in this study who schedule a repeat colonoscopy;
- Currently participating in another clinical observational trial or having participated in any other clinical trial within the past 60 days;
- Refusal to sign the written informed consent form.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zi-xuan He, M.D. contact
China1 site, 1 recruiting
- Recruiting
Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Zhao-shen Li, 13386273620, zhaoshenli@hotmail.com
Zi-xuan He, zixuan931004@163.com
About this study
Official title: Analysis of Factors Influencing the Quality of Bowel Preparation Before Colonoscopy in IBD Patients: A National Multicenter Prospective Study
The primary objectives of this project are twofold. On the one hand, it aims to investigate the current status of bowel preparation protocols and their quality in IBD patients undergoing colonoscopy, particularly focusing on the implementation of these protocols across hospitals following the release of the 2023 bowel preparation guidelines. This will further standardize and optimize bowel preparation practices in China. On the other hand, the project seeks to identify and examine various risk factors contributing to poor bowel preparation quality in IBD patients, analyze their correlation with bowel preparation scores, and develop a risk prediction model for failed bowel preparation. This will provide a theoretical foundation for formulating personalized bowel preparation regimens tailored to individual patient conditions in the future.
Read the detailed description
Step 1: During the issuance of a colonoscopy order, outpatient/ward physicians conduct preliminary screening and introduction to potential participants. Alternatively, recruitment may take place during follow-up in the recovery room or ward after the patient completes the colonoscopy (must be within 7 days post-procedure to reduce recall bias). Provide detailed explanations of the study content, risks, and benefits to potential subjects.
Step 2: Ensure that the patient fully understands the study, and then proceed to sign the "Informed Consent Form."
Step 3: Patients complete the "Questionnaire on Factors Influencing Bowel Preparation in IBD Patients." The questionnaire covers two main aspects: First, potential risk factors that may affect the quality of bowel preparation, including BMI, history of abdominal surgery, history of diabetes, history of diarrhea or constipation, stool characteristics, etc. Second, the specific bowel preparation protocol, including pre-colonoscopy diet, type of bowel cleansing agent used, dosage, interval between completion of medication and start of colonoscopy (waiting time), timing of medication intake, etc. Finally, the researcher records the bowel preparation quality score and colonoscopy results, including Boston Bowel Preparation Scale scores for each intestinal segment, colonoscopic diagnosis, endoscopic disease activity scores, etc.
- Being tested
- Standard Pre-colonoscopy Bowel Preparation Protocol
- Keywords
- IBD, Colonoscopy, Bowel preparation
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Pre-colonoscopy Bowel Preparation ProtocolOther
This involves standard clinical instructions including a low-residue diet prior to colonoscopy and the administration of bowel cleansing agents (e.g., Polyethylene Glycol) according to the split-dose regimen as per each participating center's routine practice. The timing, dosage, and specific agent used follow existing institutional guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Observational Cohort for Bowel Preparation in IBD Patients | Patients aged 18 years or older diagnosed with Inflammatory Bowel Disease (IBD) and scheduled for a colonoscopy, who undergo standard bowel preparation procedures followed by colonoscopy examination and questionnaire completion. Receives: Other: Standard Pre-colonoscopy Bowel Preparation Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
adequate bowel preparation rate
Proportion of subjects with Boston Bowel Preparation Scale (BBPS) scores ≥ 2 in all bowel segments.
Measured: The adequate bowel preparation rate can be assessed immediately upon completion of colonoscopy
Secondary outcomes (1)
Patient Satisfaction
Patient satisfaction is rated on a 5-point Likert scale ranging from 0 (very dissatisfied) to 5 (very satisfied), with patients rating their satisfaction regarding the entire bowel preparation process from the day before to immediately before the colonoscopy.
Measured: immediately upon completion of colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start8 Dec 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBD (Inflammatory Bowel Disease)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Anhui Medical University, Ankang Central Hospital, First People's Hospital of Hangzhou, Jiangmen Central Hospital, Subei People's Hospital of Jiangsu Province, Xijing Hospital, The Affiliated Hospital of Qingdao University, RenJi Hospital, Ruijin Hospital, Shanghai 10th People's Hospital, ShuGuang Hospital, Shengli Oilfield Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07335705
- Sponsor's protocol ID
- CHEC2025-448
- Status last verified
- May 2026
- First submitted
- 8 Dec 2025
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Factors Influencing the Quality of Bowel Preparation Before Colonoscopy in IBD Patients: A National Multicenter Prospective Study
- ClinicalTrials.gov ID
- NCT07335705
- Acronym / sponsor ID
- CHEC2025-448
- Keywords
- IBD, Colonoscopy, Bowel preparation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Anhui Medical University, Ankang Central Hospital, First People's Hospital of Hangzhou, Jiangmen Central Hospital, Subei People's Hospital of Jiangsu Province, Xijing Hospital, The Affiliated Hospital of Qingdao University, RenJi Hospital, Ruijin Hospital, Shanghai 10th People's Hospital, ShuGuang Hospital, Shengli Oilfield Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 13 Jan 2026 (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 primary objectives of this project are twofold. On the one hand, it aims to investigate the current status of bowel preparation protocols and their quality in IBD patients undergoing colonoscopy, particularly focusing on the implementation of these protocols across hospitals following the release of the 2023 bowel preparation guidelines. This will further standardize and optimize bowel preparation practices in China. On the other hand, the project seeks to identify and examine various risk factors contributing to poor bowel preparation quality in IBD patients, analyze their correlation with bowel preparation scores, and develop a risk prediction model for failed bowel preparation. This will provide a theoretical foundation for formulating personalized bowel preparation regimens tailored to individual patient conditions in the future.
Detailed description
Step 1: During the issuance of a colonoscopy order, outpatient/ward physicians conduct preliminary screening and introduction to potential participants. Alternatively, recruitment may take place during follow-up in the recovery room or ward after the patient completes the colonoscopy (must be within 7 days post-procedure to reduce recall bias). Provide detailed explanations of the study content, risks, and benefits to potential subjects.
Step 2: Ensure that the patient fully understands the study, and then proceed to sign the "Informed Consent Form."
Step 3: Patients complete the "Questionnaire on Factors Influencing Bowel Preparation in IBD Patients." The questionnaire covers two main aspects: First, potential risk factors that may affect the quality of bowel preparation, including BMI, history of abdominal surgery, history of diabetes, history of diarrhea or constipation, stool characteristics, etc. Second, the specific bowel preparation protocol, including pre-colonoscopy diet, type of bowel cleansing agent used, dosage, interval between completion of medication and start of colonoscopy (waiting time), timing of medication intake, etc. Finally, the researcher records the bowel preparation quality score and colonoscopy results, including Boston Bowel Preparation Scale scores for each intestinal segment, colonoscopic diagnosis, endoscopic disease activity scores, etc.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational Cohort for Bowel Preparation in IBD Patients | – | Other: Standard Pre-colonoscopy Bowel Preparation ProtocolPatients aged 18 years or older diagnosed with Inflammatory Bowel Disease (IBD) and scheduled for a colonoscopy, who undergo standard bowel preparation procedures followed by colonoscopy examination and questionnaire completion. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients (aged ≥18 years) diagnosed with Inflammatory Bowel Disease (IBD) according to the 2023 Chinese guidelines, who are scheduled to undergo a colonoscopy
Key inclusion criteria (3 listed)
- Patients aged 18 years or older, of any gender, scheduled for colonoscopy;
- Patients diagnosed with Inflammatory Bowel Disease (IBD) according to the 2023 edition of the Guidelines for the Diagnosis and Treatment of Inflammatory Bowel Disease;
- Voluntary participation in this study and provision of signed informed consent.
Key exclusion criteria (10 listed)
- History of acute myocardial infarction (within the past 6 months), severe cardiac, hepatic, or renal insufficiency, or psychiatric disorders;
- Current use of anticoagulants (e.g., aspirin, warfarin) or presence of coagulation disorders;
- Pregnant or lactating women;
- Acute intestinal infection within the past 2 weeks;
- History of colorectal tumors, familial adenomatous polyposis, or Peutz-Jeghers syndrome;
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 |
|---|---|---|
| Standard Pre-colonoscopy Bowel Preparation ProtocolThis involves standard clinical instructions including a low-residue diet prior to colonoscopy and the administration of bowel cleansing agents (e.g., Polyethylene Glycol) according to the split-dose regimen as per each participating center's routine practice. The timing, dosage, and specific agent used follow existing institutional guidelines. | Other | Observational Cohort for Bowel Preparation in IBD Patients |
Primary outcome
adequate bowel preparation rate
Time frame: The adequate bowel preparation rate can be assessed immediately upon completion of colonoscopy
Proportion of subjects with Boston Bowel Preparation Scale (BBPS) scores ≥ 2 in all bowel segments.
1 secondary outcome
Patient Satisfaction
Time frame: immediately upon completion of colonoscopy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
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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.
Zi-xuan He, M.D. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IBD (Inflammatory Bowel Disease) and 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 10 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: looking for participants now, as of the sponsor's last update on 14 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhao-shen Li, M.D. (13386273620, zhaoshenli@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adequate bowel preparation rate (time frame: The adequate bowel preparation rate can be assessed immediately upon completion of 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 14 May 2026.