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NCT Number: NCT07353853

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

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

pre-packaged low-residue diet for bowel preparation

Dietary Supplement

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yu Bai, M.D.

CONTACT

[email protected]

13564665324

Zi-xuan He, M.D.

CONTACT

[email protected]

+8615901597359

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 21, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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