NCT07165470

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Sep 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Sep 2025Dec 2026

First Submitted

Initial submission to the registry

September 1, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 10, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

May 14, 2026

Status Verified

May 1, 2026

Enrollment Period

1.3 years

First QC Date

September 1, 2025

Last Update Submit

May 12, 2026

Conditions

Colonoscopy: Bowel PreparationIBD - Inflammatory Bowel Disease

Keywords

bowel preparationcolonoscopyIBD - 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 preparationDIETARY_SUPPLEMENT

Participants will be provided with 6 sachets of pre-packaged low-residue diet one day prior to colonoscopy

Nutrition Powder Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Yu Bai, M.D.

    Changhai Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Bai, M.D.

CONTACT

+8613564665324md.baiyu@foxmail.com

Zi-xuan He, M.D.

CONTACT

+8615901597359zixuan931004@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 (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

May 14, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)