Pre-packaged Low-residue Diet for Bowel Preparation in Patients With Inflammatory Bowel Disease

Naval Military Medical University

Status: Enrolling

Conditions: IBD (Inflammatory Bowel Disease); Colonoscopy: Bowel Preparation; Colonoscopy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07353853

CHEC2025-535

Details and patient eligibility

About

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.

Full description

The project workflow is divided into three main phases. During the project initiation phase, key tasks include designing the study protocol, developing the bowel preparation assessment questionnaire, and identifying collaborating centers. In the project implementation phase, we will conduct surveys on colonoscopy bowel preparation practices across participating centers, deliver training sessions, and collect the case report forms (CRF) for this project. During the conclusion phase, we will focus on evaluating the quality of the collected CRF data, striving to ensure its authenticity, comprehensiveness, and objectivity.

Enrollment: 1,000 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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1,000 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.Patients in this group will take a total of 2 liters of polyethylene glycol electrolyte solution for bowel preparation before colonoscopy, administered as split doses (1 L in the evening before and 1 L on the morning of the procedure).

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.Patients in this group will take a total of 3 liters of polyethylene glycol electrolyte solution for bowel preparation before colonoscopy, administered as split doses (1 L in the evening before and 2 L on the morning of the procedure).