Pre-packaged low-residue diet (Maifu Changqing®) for bowel preparation in adults with IBD
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
Run by Changhai Hospital · NCT07353853 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Changhai Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | January 1, 2026 |
| Main results expected | June 30, 2026 |
| Study ends | June 30, 2026 |
| Registry record updated | May 14, 2026 |
| Trial ID | NCT07353853 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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Changhai Hospital
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Principal investigator: Yu Bai, M.D. — Changhai Hospital
- Study coordinator: Yu Bai, M.D.
- Email: md.baiyu@foxmail.com
- Phone: 13564665324
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Pre-Packaged Low-Residue Diet for Bowel Prep in IBD Patients
This study tests whether a pre-packaged low-residue diet, Maifu Changqing Complete Nutritional Formula Powder, helps bowel prep for colonoscopy in people with inflammatory bowel disease.
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Investigating bowel preparation quality before colonoscopy
This study is testing how well different bowel prep methods work for people getting a colonoscopy to see if new guidelines can help improve the process.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.