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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05878639
Other study ID # SAHoWMU-CR2023-01-104
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 28, 2023
Est. completion date July 1, 2023

Study information

Verified date July 2023
Source Second Affiliated Hospital of Wenzhou Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 140
Est. completion date July 1, 2023
Est. primary completion date July 1, 2023
Accepts healthy volunteers No
Gender All
Age group 16 Years to 75 Years
Eligibility Inclusion Criteria: - All patients with confirmed IBD or suspected IBD for at least 3 months, aged between 16-75 years and requiring a colonoscopy are invited to participate in our study. The diagnosis of IBD is based on recognized standards, including clinical symptoms, endoscopy, radiology, pathology and surgical history. Exclusion Criteria: - Patients are excluded if they (1) are clinical active UC and CD, (2) are known or suspected gastrointestinal obstruction, bowel perforation, toxic colitis or megacolon, recent or active gastrointestinal bleeding, (3) are congestive heart failure, severe renal failure, (4) are severe dehydration or electrolyte disturbances, (5) are pregnant, (6) are allergic to PEG or Lactulose, (7) are diabetics, (8) are lactose or galactose intolerance, (9) refuse to participate in this study.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
3 bottles of Lactulose oral solution
Patients will take lactulose for bowel preparation.
3L-polyethylene glycol
Patients will take 3L-polyethylene glycol for bowel preparation.

Locations

Country Name City State
China The Second Affiliated Hospital of Wenzhou Medical University Wenzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital of Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary effective preparation rate Boston Bowel Preparation Scale (BBPS) >= 6 with a partial score >= 2 in each colon segment 5 minutes before the colonoscopy ends
Primary incidence of adverse events incidence of adverse events in each group 2 hours after having bowel preparation
Primary 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
Secondary effects of bowel preparation drugs on liver function total protein, albumin, bilirubin, alanine aminotransferase 2 hours after having bowel preparation
Secondary effects of bowel preparation drugs on serum electrolyte sodium, potassium, chloride 2 hours after having bowel preparation
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