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Recruiting NCT07165470

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

No phase Interventional Colonoscopy: Bowel Preparation IBD - Inflammatory Bowel Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: pre-packaged low-residue diet for bowel preparation.
Who it may be relevant to
Registry conditions: Colonoscopy: Bowel Preparation, IBD - Inflammatory Bowel Disease. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Bowel preparation adequacy rate [Time frame: 6 months]
Secondary outcome measures (1)
  • Subject Satisfaction [Time frame: 6 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Diagnostic

Study locations

China · 2 centers
  • Changhai Hospital — Shanghai
  • Changhai Hospital — Shanghai

Identifiers

NCT: NCT07165470 · CHEC2025-312

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗