NCT07353853

Pre-packaged Low-residue Diet for Bowel Preparation in Patients With Inflammatory Bowel Disease

Pre-packaged Low-residue Diet for Bowel Preparation in Patients With Inflammatory Bowel Disease: A National Multicenter Randomized Controlled Non-inferiority Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• IBD (Inflammatory Bowel Disease)
• Colonoscopy
• Colonoscopy: Bowel Preparation

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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.

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2026-01-21
• Last updated: 2026-01-21

Locations

1 site across 1 country: China