Pre-Packaged Low-Residue Diet for Bowel Prep in IBD Patients
Official title: Pre-Packaged Low-Residue Diet Assisting Bowel Preparation in Patients With Inflammatory Bowel Disease:A National Multicenter Randomized Controlled Clinical Trial
Run by Changhai Hospital · NCT07165470 · Data updated 2026-11-12
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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Changhai Hospital Academic / other |
| Locations | 2 sites (Shanghai, Shanghai Municipality and 1 other locations) |
| Status | Recruiting |
| Started | September 1, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | May 14, 2026 |
| Trial ID | NCT07165470 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 to 75 with a confirmed diagnosis of IBD undergoing colonoscopy and able to consent.
✕Probably not a fit
Patients who do not benefit may include those without bowel prep issues or with conditions that interfere with diet-based preparation, or those with contraindications to the nutritional formula.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The trial compares two approaches to bowel preparation before colonoscopy in adults with IBD: a conventional low-residue diet versus the same diet supplemented with Maifu Changqing Complete Nutritional Formula Powder, initiated 24 hours before the procedure. It uses a randomized design across multiple centers to collect data on bowel cleansing quality, nutritional status, and comfort during prep. Data are gathered via standardized case report forms and quality control procedures ensure accuracy and adherence to GCP standards. The study aims to improve both the effectiveness of bowel prep and the patient experience in the IBD population.
Why it matters
Potential benefit: If successful, patients could experience better bowel cleansing and improved comfort during prep, potentially leading to easier colonoscopy and better detection.
How similar studies have gone: Previous studies in related settings suggest dietary modifications can influence bowel-prep quality, but this specific pre-packaged formula approach in IBD is novel and requires confirmation.
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
-
Changhai Hospital
Shanghai, Shanghai Municipality, China Recruiting -
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: +8613564665324
Similar studies
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Pre-packaged low-residue diet (Maifu Changqing®) for bowel preparation in adults with IBD
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.
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This project will test whether current bowel-prep practices and individual patient factors affect how clean the bowel is for people with IBD having a colonoscopy.
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This will test whether the SMART-IBD smartphone app helps adolescents ages 13–17 with IBD take their medicines and manage symptoms better than completing daily diaries alone.
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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.