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

NCT07165470 | Not Yet Recruiting

• 1 other identifier: CHEC2025-312
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colonoscopy: Bowel Preparation; IBD - Inflammatory Bowel Disease

Keywords

bowel preparation; colonoscopy; IBD - Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

• Bowel preparation adequacy rate

  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 Outcomes (1)

• Subject Satisfaction

  6 months

Study Arms (2)

Nutrition Powder Group

EXPERIMENTAL

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.

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

Standard Low-Residue Diet Group

NO INTERVENTION

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.

Interventions

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

Nutrition Powder Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Yu Bai, M.D.

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Bai, M.D.

CONTACT

+8613564665324; md.baiyu@foxmail.com

Zi-xuan He, M.D.

CONTACT

+8615901597359; zixuan931004@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 10, 2025
• Study Start: September 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)