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

Naval Military Medical University

Status: Not yet enrolling

Conditions: Colonoscopy: Bowel Preparation; IBD - Inflammatory Bowel Disease

Treatments: Dietary Supplement: pre-packaged low-residue diet for bowel preparation

Study type: Interventional

Funder types: Other

Identifiers

NCT07165470

CHEC2025-312

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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500 participants in 2 patient groups

Nutrition Powder Group

Experimental group

Description:

Participants will be provided with 6 sachets of pre-packaged low-residue diet one day prior to colonoscopy, to be consumed as needed in multiple servings during the day.

Treatment:

Dietary Supplement: pre-packaged low-residue diet for bowel preparation

Standard Low-Residue Diet Group

No Intervention group

Description:

Participants follow standard low-residue diet guidelines (like ESPEN recommendations) for 24 hours before colonoscopy. This includes rice water, congee, noodles, and steamed eggs, while avoiding fruits/juices, vegetables, nuts, and other high-fiber foods.