MedTrace Logo

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

NCT06748638 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 444

Last updated 2024-12-27

No results posted yet for this study

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.

Conditions

  • Lactulose
  • Bowel Preparation

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.

Sponsors & Collaborators

  • Haifeng Lan

    lead OTHER

Principal Investigators

  • Ji Xuan · Jinling Hospital, China

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2025-10-01
Completion
2025-10-01

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06748638 on ClinicalTrials.gov