beta
Trial Radar AI
Clinical Trial NCT07353853 for IBD (Inflammatory Bowel Disease), Colonoscopy, Colonoscopy: Bowel Preparation is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
One study matched filter criteria
Card View
Back to Search

Pre-packaged Low-residue Diet for Bowel Preparation in Patients With Inflammatory Bowel Disease 1,000 Dietary

Recruiting
Clinical Trial NCT07353853 is an interventional study for IBD (Inflammatory Bowel Disease), Colonoscopy, Colonoscopy: Bowel Preparation that is recruiting. It started on January 1, 2026 with plans to enroll 1,000 participants. Led by Changhai Hospital, it is expected to complete by June 30, 2026. The latest data from ClinicalTrials.gov was last updated on January 21, 2026.
Brief Summary
The primary objectives of this project are twofold: firstly, to evaluate the role of Maifu Changqing® Complete Nutrition Formula Powder in bowel preparation for colonoscopy in patients with IBD; and secondly, to enhance the nutritional support and comfort of bowel preparation for IBD patients.
Detailed Description
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...Show More
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

Conditions
IBD (Inflammatory Bowel Disease)ColonoscopyColonoscopy: Bowel Preparation
Other Study IDs
  • CHEC2025-535
NCT ID Number
NCT07353853
Start Date (Actual)
2026-01-01
Last Update Posted
2026-01-21
Completion Date (Estimated)
2026-06-30
Enrollment (Estimated)
1,000
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
IBD
Colonoscopy
Bowel preparation
Primary Purpose
Diagnostic
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalNutrition Powder Group
Participants will be provided with 6 sachets of pre-packaged low-residue diet one day prior to colonoscopy, to be consumed as needed in multiple servings during the day.Patients in this group will take a total of 2 liters of polyethylene glycol electrolyte solution for bowel preparation before colonoscopy, administered as split doses (1 L in the evening before and 1 L on the morning of the procedure).
pre-packaged low-residue diet for bowel preparation
Participants will be provided with 6 sachets of pre-packaged low-residue diet one day prior to colonoscopy.Patients in this group will take a total of 2 liters of polyethylene glycol electrolyte solution for bowel preparation before colonoscopy.Stool specimens from patients will be sent for Genetic Analysis of gut microbiota.
No InterventionStandard Low-Residue Diet Group
Participants follow standard low-residue diet guidelines (like ESPEN recommendations) for 24 hours before colonoscopy. This includes rice water, congee, noodles, and steamed eggs, while avoiding fruits/juices, vegetables, nuts, and other high-fiber foods.Patients in this group will take a total of 3 liters of polyethylene glycol electrolyte solution for bowel preparation before colonoscopy, administered as split dose...Show More
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Bowel preparation adequacy rate
Bowel preparation adequacy rate:Proportion of subjects with a Boston Bowel Preparation Scale (BBPS) score of ≥2 in each segment.The BBPS ranges from 0 to 3 per segment (total score 0-9), with higher scores indicating better bowel cleanliness.
6 months
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Subject Satisfaction
Subjects' subjective satisfaction with and willingness to repeat the entire bowel preparation process, assessed using a Visual Analogue Scale (VAS).The VAS is a 100-mm horizontal line anchored at "extremely dissatisfied" (0 mm) and "extremely satisfied" (100 mm). Higher scores indicate greater satisfaction.
6 months
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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.

  • 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.
Changhai Hospital logoChanghai Hospital
Study Responsible Party
Zhaoshen Li, Principal Investigator, professor, Changhai Hospital
Study Central Contact
Contact: Yu Bai, M.D., 13564665324, [email protected]
Contact: Zi-xuan He, M.D., +8615901597359, [email protected]
1 Study Locations in 1 Countries

Shanghai Municipality

Changhai Hospital, Shanghai, Shanghai Municipality, 200433, China
Yu Bai, M.D., Contact, 13564665324, [email protected]
Zi-xuan He, M.D., Contact, +8615901597359, [email protected]
Jing Qiao, Sub-Investigator
Recruiting