NCT07165470

Pre-Packaged Low-Residue Diet Assisting Bowel Preparation in Patients With Inflammatory Bowel Disease

Pre-Packaged Low-Residue Diet Assisting Bowel Preparation in Patients With Inflammatory Bowel Disease：A National Multicenter Randomized Controlled Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives of this study are as follows: 1.To evaluate the efficacy of Maifu Changqing® Complete Nutritional Formula Powder in bowel preparation for colonoscopy among inflammatory bowel disease (IBD) patients;2.To enhance nutritional status and procedural comfort during bowel preparation in the IBD population.

Detailed description

The project workflow comprises three consecutive phases: In the initiation phase, key activities include designing the study protocol, developing a bowel preparation assessment questionnaire, and establishing collaborative multicenter partnerships. During the implementation phase, subjects will be randomized into two arms-the control arm receiving conventional low-residue diet and the intervention arm administered Maifu Changqing® Complete Nutritional Formula Powder-with both regimens initiated 24 hours prior to colonoscopy. Clinical data will be systematically collected while Case Report Forms (CRFs) from all participating centers are centrally aggregated. The conclusion phase focuses on CRF quality control through standardized verification procedures to ensure data integrity, completeness, and objectivity according to Good Clinical Practice (GCP) standards.

Conditions

• Colonoscopy: Bowel Preparation
• IBD - Inflammatory Bowel Disease

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

Timeline

• Start date: 2025-09-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2025-09-10
• Last updated: 2025-09-10

Locations

1 site across 1 country: China