Investigating a new bowel preparation method for 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

This study is testing a new way to prepare the bowels for colonoscopy in people with inflammatory bowel disease to see if it works better than the usual method.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 144 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Locations: 9 sites (Beijing, Beijing and 8 other locations)
• Trial ID: NCT05485103 on ClinicalTrials.gov

What this trial studies

This study aims to compare a modified bowel preparation method for colonoscopy against the traditional approach in patients with inflammatory bowel disease (IBD). It will assess the effectiveness of bowel cleansing, the quality of colonoscopy examinations, and the overall clinical condition of patients with ulcerative colitis and Crohn's disease. Additionally, the study will explore risk factors that may influence the quality of bowel preparation. Participants will receive polyethylene glycol as part of the intervention.

Who should consider this trial

Good fit: Ideal candidates include patients diagnosed with inflammatory bowel disease, specifically those with colonic involvement.

Not a fit: Patients with acute abdominal diseases, recent colon surgery, or those unable to cooperate with the bowel preparation method may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved bowel preparation methods, enhancing the quality of colonoscopy examinations for patients with inflammatory bowel disease.

How similar studies have performed: While similar studies have explored bowel preparation methods, this specific approach is novel and has not been extensively tested.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing and 8 other locations

• Peking Union Medical College Hospital — Beijing, Beijing, China (Recruiting)
• Beijing Chaoyang Hospital, Capital Medical University — Beijing, Beijing, China (Recruiting)
• Beijing Sixth Hospital — Beijing, Beijing, China (Recruiting)
• Heilongjiang Provincial Hospital — Ha'erbin, Heilongjiang, China (Recruiting)
• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)
• The first Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)
• The second Affiliated Hospital of Baotou Medical Colledge — Baotou, Neimenggu, China (Recruiting)
• The First People's Hospital of Yunnan Province — Kunming, Yunnan, China (Recruiting)
• Beijing Rectum Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Hui Xu, MD

Conditions Inflammatory Bowel Diseases; modified bowel preparation method; inflammatory bowel disease; risk factors; quality of bowel preparation