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ENROLLING BY INVITATION
NCT06748638
PHASE4

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

Sponsor: Haifeng Lan

View on ClinicalTrials.gov

Summary

This is a single-center, single-blind, randomized controlled clinical study. Participants meeting the inclusion criteria were randomly assigned to lactulose + linaclotide group, lactulose group, and PEG group in equal proportion. In this study, the effectiveness, tolerability, adverse reactions and prognosis of three intestinal preparation regimens: lactulose -linalotide group, lactulose group and PEG group were compared by evaluating the intestinal cleanliness rate (BBPS score) of patients and quantitative analysis of intestinal bubble under colonoscopy, with a view to improving the intestinal cleanliness rate of colonoscopy subjects.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

444

Start Date

2024-09-01

Completion Date

2025-10-01

Last Updated

2024-12-27

Healthy Volunteers

Yes

Interventions

DRUG

Lactulose

At 20:00 the night before the examination, pour 2 boxes of lactilose into a cup, add 1000ml of water and drink it; 4 to 6 hours before the examination, dissolve the third box of lactulose into 1000ml water, and drink it; Until pale yellow or clear dung water is drawn.

DRUG

Lactulose+ linaclotide

1 capsule of linalotide (290ug) taken orally half an hour before meal at 12:00 noon on the previous day, and two doses were taken after 20:00 according to the above Lactulose-taking method.

DRUG

polyethylene glycol (PEG)

a bag of PEG was dissolved into 1L at 20:00 1d before the examination, and was drunk at a constant rate within 2h; 4 to 6 hours before the inspection, dissolve the second bag of PEG into 2L water and drink it.

Locations (1)

Jinling Hospital, China

Nanjing, Jiangsu, China