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The goal of this clinical trial is to evaluate the efficacy, safety and tolerability of lactulose in bowel preparation in IBD patients. The main question it aims to answer is: Does lactulose have better efficacy, safety and tolerability than 3L-PEG? Participants will be divided into PEG group or Lactulose group at a 1:1 ratio by a random number method. Each patient will get a leaflet provided by hospital introducing bowel preparation methods and diet restriction before bowel preparation. They will have bowel preparation with different drugs according to group. The grade of bowel cleansing will be assessed through the Boston Bowel Preparation Scale (BBPS). The tolerability, satisfaction and safety of the two bowel preparation methods will be assessed through the patients self-administered questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients take Lactulose for bowel preparation | Experimental | Patients take Lactulose for bowel preparation. |
|
| Patients take 3L-polyethylene glycol for bowel preparation | Active Comparator | Patients take 3L-polyethylene glycol for bowel preparation . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3 bottles of Lactulose oral solution | Drug | Patients will take lactulose for bowel preparation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| effective preparation rate | Boston Bowel Preparation Scale (BBPS) >= 6 with a partial score >= 2 in each colon segment | 5 minutes before the colonoscopy ends |
| incidence of adverse events | incidence of adverse events in each group | 2 hours after having bowel preparation |
| taste score evaluated by patients | Five-point scale is used to evaluate taste (very bad, bad, moderate, good, very good) | 2 hours after having bowel preparation |
| Measure | Description | Time Frame |
|---|---|---|
| effects of bowel preparation drugs on liver function | total protein, albumin, bilirubin, alanine aminotransferase | 2 hours after having bowel preparation |
| effects of bowel preparation drugs on serum electrolyte |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lin Daopo | Department of Gastroenterology, The Second Affiliated Hospital of Wenzhou Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | 325000 | China |
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| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| ID | Term |
|---|---|
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| 3L-polyethylene glycol | Drug | Patients will take 3L-polyethylene glycol for bowel preparation. |
|
sodium, potassium, chloride
| 2 hours after having bowel preparation |
| D011108 |
| Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |