Pre-packaged Low-residue Diet for Bowel Preparation in Patients With Inflammatory Bowel Disease: A National Multicenter Randomized Controlled Non-inferiority Clinical Trial
Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Changhai Hospital
RECRUITING
Shanghai
Contact Information
Primary
Yu Bai, M.D.
md.baiyu@foxmail.com
13564665324
Backup
Zi-xuan He, M.D.
zixuan931004@163.com
+8615901597359
Time Frame
Start Date: 2026-01-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 1000
Treatments
Experimental: Nutrition Powder Group
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.Patients in this group will take a total of 2 liters of polyethylene glycol electrolyte solution for bowel preparation before colonoscopy, administered as split doses (1 L in the evening before and 1 L on the morning of the procedure).
No_intervention: Standard Low-Residue Diet Group
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.Patients in this group will take a total of 3 liters of polyethylene glycol electrolyte solution for bowel preparation before colonoscopy, administered as split doses (1 L in the evening before and 2 L on the morning of the procedure).
Related Therapeutic Areas
Sponsors
Collaborators: Ankang Central Hospital, Jiangmen Central Hospital, Ruijin Hospital, RenJi Hospital, First People's Hospital of Hangzhou, Xijing Hospital, The Affiliated Hospital of Qingdao University, Shengli Oilfield Hospital, ShuGuang Hospital, Shanghai 10th People's Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Subei People's Hospital of Jiangsu Province, The First Affiliated Hospital of Anhui Medical University
Leads: Changhai Hospital