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Pre-packaged Low-residue Diet for Bowel Preparation in Patients With Inflammatory Bowel Disease
NCT07353853 · Changhai Hospital
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Pre-packaged Low-residue Diet for Bowel Preparation in Patients With Inflammatory Bowel Disease: A National Multicenter Randomized Controlled Non-inferiority Clinical Trial
About this study
The project workflow is divided into three main phases. During the project initiation phase, key tasks include designing the study protocol, developing the bowel preparation assessment questionnaire, and identifying collaborating centers. In the project implementation phase, we will conduct surveys on colonoscopy bowel preparation practices across participating centers, deliver training sessions, and collect the case report forms (CRF) for this project. During the conclusion phase, we will focus on evaluating the quality of the collected CRF data, striving to ensure its authenticity, comprehensiveness, and objectivity.
Eligibility criteria
Inclusion Criteria:
* Age: Adult patients between 18 and 75 years old;
* Diagnosis of IBD according to the 2023 Guidelines for the Diagnosis and Treatment of Inflammatory Bowel Disease;
* Voluntary participation in this clinical trial and provision of signed informed consent.
Exclusion Criteria:
* Patients with acute IBD, severe conditions, combined with major bleeding, suspected toxic megacolon, CD with severe intestinal stricture, gastrointestinal obstruction, or other conditions deemed unsuitable for colonoscopy by the physician;
* Patients with severe cardiac, pulmonary, hepatic, or renal dysfunction;
* History of previous colorectal surgical resection or use of medications that may affect intestinal motility within one week (e.g., antidepressants, sedatives, calcium channel blockers);
* History of stroke, spinal cord injury, or psychiatric disorders that impair compliance with bowel preparation and colonoscopy;
* Allergy to any component of the administered drugs or meal replacements;
* Pregnant or lactating women, and other individuals considered unsuitable for bowel preparation and colonoscopy by the physician.
Study design
Enrollment target: 1000 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2026-01-01
Estimated completion: 2026-06-30
Last updated: 2026-01-21
Interventions
Dietary Supplement: pre-packaged low-residue diet for bowel preparation
Primary outcomes
- • Bowel preparation adequacy rate (6 months)
Sponsor
Changhai Hospital · other
Contacts & investigators
ContactYu Bai, M.D. · contact · md.baiyu@foxmail.com · 13564665324
ContactZi-xuan He, M.D. · contact · zixuan931004@163.com · +8615901597359
InvestigatorYu Bai, M.D. · principal_investigator, Changhai Hospital
All locations (1)
Changhai HospitalRecruiting
Shanghai, Shanghai Municipality, China