RecruitingNot ApplicableNCT07353853

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


Sponsor

Changhai Hospital

Enrollment

1,000 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria3

  • 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 Criteria6

  • 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.

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Interventions

DIETARY_SUPPLEMENTpre-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.


Locations(1)

Changhai Hospital

Shanghai, Shanghai Municipality, China

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NCT07353853


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