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| Name | Class |
|---|---|
| The First Affiliated Hospital of Anhui Medical University | OTHER |
| Ankang Central Hospital | OTHER |
| First People's Hospital of Hangzhou | OTHER |
| Jiangmen Central Hospital |
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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.
The project workflow comprises three consecutive phases: In the initiation phase, key activities include designing the study protocol, developing a bowel preparation assessment questionnaire, and establishing collaborative multicenter partnerships. During the implementation phase, subjects will be randomized into two arms-the control arm receiving conventional low-residue diet and the intervention arm administered Maifu Changqing® Complete Nutritional Formula Powder-with both regimens initiated 24 hours prior to colonoscopy. Clinical data will be systematically collected while Case Report Forms (CRFs) from all participating centers are centrally aggregated. The conclusion phase focuses on CRF quality control through standardized verification procedures to ensure data integrity, completeness, and objectivity according to Good Clinical Practice (GCP) standards.
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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. |
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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. |
| 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 |
| 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 | +8613564665324 | 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 |
| Subei People's Hospital of Jiangsu Province | OTHER |
| Xijing Hospital | OTHER |
| The Affiliated Hospital of Qingdao University | OTHER |
| RenJi Hospital | OTHER |
| Ruijin Hospital | OTHER |
| Shanghai 10th People's Hospital | OTHER |
| ShuGuang Hospital | OTHER |
| Shengli Oilfield Hospital | OTHER |
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
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| Changhai Hospital | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
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