NCT07335705

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Dec 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Dec 2025Oct 2026

First Submitted

Initial submission to the registry

December 8, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

December 8, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

10 months

First QC Date

December 8, 2025

Last Update Submit

April 17, 2026

Conditions

Keywords

IBDColonoscopyBowel preparation

Outcome Measures

Primary Outcomes (1)

  • adequate bowel preparation rate

    Proportion of subjects with Boston Bowel Preparation Scale (BBPS) scores ≥ 2 in all bowel segments.

    The adequate bowel preparation rate can be assessed immediately upon completion of colonoscopy

Secondary Outcomes (1)

  • Patient Satisfaction

    immediately upon completion of colonoscopy

Study Arms (1)

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.

Other: Standard Pre-colonoscopy Bowel Preparation Protocol

Interventions

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.

Observational Cohort for Bowel Preparation in IBD Patients

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Central Study Contacts

Zhao-shen Li, M.D.

CONTACT

Zi-xuan He, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

December 8, 2025

First Posted

January 13, 2026

Study Start

December 8, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

April 22, 2026

Record last verified: 2026-04

Locations