Clinical Study on the Application of Lactulose Combined with Linaclotide in Bowel Preparation for Colonoscopy

Launched by HAIFENG LAN · Dec 21, 2024

Keywords

ClinConnect Summary

1. Research program design This study was designed as a single-center, single-blind, randomized controlled clinical study.
2. Entry criteria Patients aged ≥18 years and ≤80 years who need intestinal preparation before colonoscopy.
3. Study sample size In this study, PASS 15 software was used to estimate the sample size. According to previous research data, the intestinal cleanliness rates of lactulose group (experimental group 1), lactulose + linalotide group (experimental group 2) and PEG group (control group) were set to be 86%, 90% and 69.36%, respectively, and the differences between th...

Gender

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Eligibility criteria

• • Inclusion Criteria:Participants must meet all of the following criteria to enter the trial.
• • 1. Signed written informed consent;
• • 2. Age 18-80 years old, gender is not limited;
• • 3. The subjects could follow the follow-up plan, objectively describe the symptoms, and cooperate with the completion of the scale;
• • 4. Non-lactating pregnant women and no pregnancy plan during the test;
• • 5. Do not participate in any clinical trials for 3 months before and during the trial;
• • Exclusion Criteria: Subjects must exclude all of the following conditions to enter the study.
• • 1. Presence of any contraindications to colonoscopy (gastrointestinal obstruction or perforation, severe acute inflammatory bowel disease, toxic megacolon, severe heart failure, renal failure, or liver failure, etc.)
• • 2. Patients with galactosemia;
• • 3. Pregnancy or lactation;
• • 4. Allergic to intestinal preparation drugs;
• • 5. Termination of the experiment for any other reason.