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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07353853

Enrollment

1000

Registered

2026-01-21

Start date

2026-01-01

Completion date

2026-06-30

Last updated

2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonoscopy, Colonoscopy: Bowel Preparation, IBD (Inflammatory Bowel Disease)

Keywords

IBD, Colonoscopy, Bowel preparation

Brief 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.

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.

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Bowel preparation adequacy rate	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.

Secondary

Measure	Time frame	Description
Subject Satisfaction	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.

Countries

China

Contacts

CONTACTYu Bai, M.D.

md.baiyu@foxmail.com13564665324

CONTACTZi-xuan He, M.D.

zixuan931004@163.com+8615901597359

PRINCIPAL_INVESTIGATORYu Bai, M.D.

Changhai Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 15, 2026