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A Prospective Study of the Effect of Modified Colonoscopy Bowel Preparation Program on Intestinal Cleaning, Examination and Disease in Patients With Inflammatory Bowel Disease

A Prospective Study of the Effect of Modified Colonoscopy Bowel Preparation Program on Intestinal Cleaning, Examination and Disease in Patients With Inflammatory Bowel Disease

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05485103
Enrollment
144
Registered
2022-08-03
Start date
2022-09-01
Completion date
2024-12-31
Last updated
2023-12-26

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

Conditions

Inflammatory Bowel Diseases

Keywords

modified bowel preparation method, inflammatory bowel disease, risk factors, quality of bowel preparation

Brief summary

The purpose of this study is to investigate the effect of modified colonoscopy bowel preparation method compared with traditional method on bowel cleansing effect, colonoscopy examination effect and clinical condition of inflammatory bowel disease patients. Risk factors affecting the quality of bowel preparation will also be studied.

Interventions

Take asol as total enteral nutrition, and take polyethylene glycols and glycerin enema as bowel preparations

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Diagnosis: inflammatory bowel disease (IBD) patients, including ulcerative colitis (UC) and Crohn's disease (CD), have colonic involvement. * Patients and/or family members can understand the study protocol and are willing to participate in the study and provide informed consent in writing.

Exclusion criteria

* The diagnosis is not definite. * Toxic megacolon, gastrointestinal perforation or other acute abdominal diseases; Patients with gastrointestinal bleeding with unstable vital signs. * Patients after colon surgery. * Serious underlying diseases, organ failure, or inability to cooperate with colonoscopy for other reasons. * Patients can not cooperate with the use of polyethylene glycol or glycerin enema. * Patients or family members cannot understand the conditions and objectives of this study.

Design outcomes

Primary

MeasureTime frameDescription
The quality of bowel preparation evaluated by endoscopists during colonoscopy.During colonoscopy examinationThe quality of bowel preparation will be evaluated with the Boston bowel preparation scale (BBPS), including the total Boston score (range 0-9, score 8-9 means excellent, 7 means good, less than 7 means bad) and score of per bowel segment (maximum 3).
Number of Participants with increased Disease activity after colonoscopy.Within 7 days after colonoscopyDisease activity will be assessed using C-reactive protein (CRP) measurement, the modified Mayo score in ulcerative colitis and the Crohn's Disease Activity Index score in Crohn's Disease. If the result after colonoscopy was higher than before, the participant may be considered with increased disease activity.

Secondary

MeasureTime frameDescription
Tolerance score of participants after bowel preparation.After bowel preparation and before colonoscopyTolerance score is defined range 0-10 (0 means totally intolerant, 10 means feel really good).
Number of Participants who has a record of outpatient or emergency treatment due to aggravation of disease after colonoscopy.Within 30 days after colonoscopyNumber of Participants who has a record of outpatient or emergency treatment due to aggravation of disease within 30 days after colonoscopy.
Number of Participants hospitalized because of aggravation of disease after colonoscopy.Within 30 days after colonoscopyNumber of Participants who is hospitalized because of aggravation of disease within 30 days after colonoscopy.

Countries

China

Contacts

Primary ContactHui Xu, MD
xuhui10799@pumch.cn+86-010-69151591
Backup ContactHong Yang, MD
yangh@pumch.cn

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026