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| Name | Class |
|---|---|
| The First Affiliated Hospital of Anhui Medical University | OTHER |
| Ankang Central Hospital | OTHER |
| Jiangmen Central Hospital | OTHER |
| The Affiliated Hospital of Qingdao University |
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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.
The project workflow is divided into three main phases. During the project initiation phase, key tasks include designing the study protocol, developing the bowel preparation assessment questionnaire, and identifying collaborating centers. In the project implementation phase, we will conduct surveys on colonoscopy bowel preparation practices across participating centers, deliver training sessions, and collect the case report forms (CRF) for this project. During the conclusion phase, we will focus on evaluating the quality of the collected CRF data, striving to ensure its authenticity, comprehensiveness, and objectivity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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.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). |
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| 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.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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pre-packaged low-residue diet for bowel preparation | Dietary Supplement | Participants will be provided with 6 sachets of pre-packaged low-residue diet one day prior to colonoscopy.Patients in this group will take a total of 2 liters of polyethylene glycol electrolyte solution for bowel preparation before colonoscopy.Stool specimens from patients will be sent for Genetic Analysis of gut microbiota. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu Bai, M.D. | Contact | 13564665324 | md.baiyu@foxmail.com | |
| Zi-xuan He, M.D. | Contact | +8615901597359 | zixuan931004@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yu Bai, M.D. | Changhai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai Hospital | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| OTHER |
| RenJi Hospital | OTHER |
| Ruijin Hospital | OTHER |
| Shanghai 10th People's Hospital | OTHER |
| Shengli Oilfield Hospital | OTHER |
| First People's Hospital of Hangzhou | OTHER |
| Subei People's Hospital of Jiangsu Province | OTHER |
| Xijing Hospital | OTHER |
| ShuGuang Hospital | OTHER |
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
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