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

NCTNCT06748638Other idDZQH-KYLL-24-35

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Overview

Status: Status unknown
Phase: Phase 4
Enrollment: 444 participants (estimated)
Sponsor: Haifeng Lan · Other
Design: Randomized · Single masking
Countries: 1 country
China
Start: 1 Sept 2024
Primary completion: 1 Oct 2025 (estimated)
Completion: 1 Oct 2025 (estimated)
First posted: 27 Dec 2024
Last update posted: 27 Dec 2024
Conditions: Lactulose · Bowel Preparation

Timeline

1 trial

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202420252026

Ph 4
Clinical Study on the Application of Lactulose Combined with Linaclotide in Bowel Preparation for Colonoscopy
NCT06748638
1 Sept 2024 to est. 1 Oct 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

LactuloseDrug
Lactulose+ linaclotideDrug
polyethylene glycol (PEG)Drug

Arms3

Experimental
Lactulose group ( group 1)
lactulose oral solution, Duphalac, 15ml/ bag, 6 bags/box
Experimental
Lactulose + linaclotide group（group 2）
Lactulose+ linaclotide 290μg (linaclotide capsule, Lingzeshu, 290ug/ capsule, 7 capsules/box) :
Experimental
3L PEG group（group 3）
Polyethylene Glycol （PEG）：Heshuang, 137.15g/ bag ，

Primary outcomes1

Outcomes the sponsor listed as primary.

Bowel preparation quality
Time frame · 1 day of scheduled colonoscopy
Registry description
The proportion of subjects with an overall Boston score ≥6 and a colon score ≥2 for each segment was considered valid. The Boston bowel preparation scale (BBPS) can be used to evaluate indicators such as the volume, shape and mucosal clarity of stool and fluid in the bowel. The scoring criteria are as follows: 0 score: uncleared stool in the colon with indistinct mucosa, most commonly in the stage without bowel preparation; 1: Part of the intestinal mucosa was clearly displayed, while the other part of the mucosa was not clearly displayed due to feces and opaque liquid residues; 2 points: There is a small amount of stool and opaque liquid remaining in the colon; 3 points: All mucous membranes are clearly displayed, and no stool or opaque fluid remains in the colon. Rating description: * The colon score of each segment was 0\~3, and the total score was 0\~9. ② The colon score of each segment was ≥2 points, indicating adequate intestinal preparation; ③ The total score of 6 and the score o

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 80 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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.

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