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

May 12, 2026 updated by: Zhaoshen Li, Changhai Hospital

Pre-packaged Low-residue Diet for Bowel Preparation in Patients With Inflammatory Bowel Disease: A National Multicenter Randomized Controlled Non-inferiority Clinical Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200433
        • Recruiting
        • Changhai Hospital
        • Contact:
        • Sub-Investigator:
          • Jing Qiao
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nutrition Powder Group
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).
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.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.
No Intervention: Standard Low-Residue Diet Group
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bowel preparation adequacy rate
Time Frame: 6 months
Bowel preparation adequacy rate:Proportion of subjects with a Boston Bowel Preparation Scale (BBPS) score of ≥2 in each segment.The BBPS ranges from 0 to 3 per segment (total score 0-9), with higher scores indicating better bowel cleanliness.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subject Satisfaction
Time Frame: 6 months
Subjects' subjective satisfaction with and willingness to repeat the entire bowel preparation process, assessed using a Visual Analogue Scale (VAS).The VAS is a 100-mm horizontal line anchored at "extremely dissatisfied" (0 mm) and "extremely satisfied" (100 mm). Higher scores indicate greater satisfaction.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Collaborators

Xijing Hospital
First People's Hospital of Hangzhou
The First Affiliated Hospital of Anhui Medical University
RenJi Hospital
The Affiliated Hospital of Qingdao University
Shanghai 10th People's Hospital
Ruijin Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ShuGuang Hospital
Subei People's Hospital of Jiangsu Province
Jiangmen Central Hospital
Ankang Central Hospital
Shengli Oilfield Hospital

Investigators

  • Principal Investigator: Yu Bai, M.D., Changhai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

January 12, 2026

First Submitted That Met QC Criteria

January 12, 2026

First Posted (Actual)

January 21, 2026

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHEC2025-535

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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