Pre-Packaged Low-Residue Diet Assisting Bowel Preparation in Patients With Inflammatory Bowel Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChanghai Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
pre-packaged low-residue diet for bowel preparation
Dietary supplementParticipants will be provided with 6 sachets of pre-packaged low-residue diet one day prior to colonoscopy
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: Nutrition Powder GroupExperimental treatment 1 intervention
Group B: Standard Low-Residue Diet GroupNo intervention 0 interventions
Trial outcomes
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.
Time frame
6 monthsSecondary outcomes
1
Subject Satisfaction
Subjects' subjective satisfaction with and willingness to repeat the entire bowel preparation process, assessed using a Visual Analogue Scale (VAS).The VAS is a 100-mm horizontal line anchored at "extremely dissatisfied" (0 mm) and "extremely satisfied" (100 mm). Higher scores indicate greater satisfaction.
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Changhai Hospital
Lead sponsor
The First Affiliated Hospital of Anhui Medical University
Collaborator
Ankang Central Hospital
Collaborator
First People's Hospital of Hangzhou
Collaborator
Jiangmen Central Hospital
Collaborator
Subei People's Hospital of Jiangsu Province
Collaborator
Xijing Hospital
Collaborator
The Affiliated Hospital of Qingdao University
Collaborator
RenJi Hospital
Collaborator
Ruijin Hospital
Collaborator
Shanghai 10th People's Hospital
Collaborator
ShuGuang Hospital
Collaborator
Shengli Oilfield Hospital
Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator
Source ClinicalTrials.gov