Pre-packaged low-residue diet (Maifu Changqing®) for bowel preparation in adults with IBD

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

This project will see if a pre-packaged low-residue nutrition powder (Maifu Changqing®) makes bowel preparation easier and better nourishes adults with IBD who are having a colonoscopy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1000 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Changhai Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07353853 on ClinicalTrials.gov

What this trial studies

The project tests a pre-packaged low-residue nutrition formula given as part of bowel preparation for adults with inflammatory bowel disease. It is organized in three phases: protocol and questionnaire design, multi-center implementation with surveys, training and case report form collection, and final data quality evaluation. Participating centers will administer the Maifu Changqing® Complete Nutrition Formula Powder during the bowel-prep period and record tolerability, nutritional parameters, and bowel cleanliness outcomes. The study will aggregate CRF data across sites to determine whether the packaged diet improves patient comfort and the quality of bowel preparation for colonoscopy.

Who should consider this trial

Good fit: Adults aged 18–75 with a diagnosis of inflammatory bowel disease per current guidelines who are willing to provide informed consent and undergo colonoscopy are the intended participants.

Not a fit: Patients with acute severe IBD complications (major bleeding, suspected toxic megacolon), severe organ dysfunction, intestinal obstruction or severe strictures, recent colorectal surgery, relevant medication use affecting motility, or allergy to study components are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this approach could make bowel preparation more comfortable and better maintain nutrition for IBD patients undergoing colonoscopy, potentially improving prep quality and tolerance.

How similar studies have performed: Previous work in general colonoscopy populations has shown low-residue diets can provide bowel cleanliness comparable to clear-liquid regimens, but using a pre-packaged nutrition formula specifically for IBD patients is relatively novel.

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Changhai Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Yu Bai, M.D. — Changhai Hospital
• Study coordinator: Yu Bai, M.D.

Conditions IBD; Colonoscopy; Colonoscopy: Bowel Preparation; Bowel preparation