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

NCT06748638 | Enrolling By Invitation Phase 4 DMC

• 1 other identifier: DZQH-KYLL-24-35
• Study Type: interventional
• Target: 444
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Lactulose; Linaclotide; bowel preparation; colonoscope

Outcome Measures

Primary Outcomes (1)

• Bowel preparation quality

  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

  1 day of scheduled colonoscopy

Study Arms (3)

Lactulose group ( group 1)

EXPERIMENTAL

lactulose oral solution, Duphalac, 15ml/ bag, 6 bags/box

Drug: Lactulose

Lactulose + linaclotide group（group 2）

EXPERIMENTAL

Lactulose+ linaclotide 290μg (linaclotide capsule, Lingzeshu, 290ug/ capsule, 7 capsules/box) :

Drug: Lactulose+ linaclotide

3L PEG group（group 3）

EXPERIMENTAL

Polyethylene Glycol （PEG）：Heshuang, 137.15g/ bag ，

Drug: polyethylene glycol (PEG)

Interventions

Lactulose DRUG

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.

Lactulose group ( group 1)

Lactulose+ linaclotide DRUG

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.

Lactulose + linaclotide group（group 2）

polyethylene glycol (PEG) DRUG

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.

3L PEG group（group 3）

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent;
• Age 18-80 years old, gender is not limited;
• The subjects could follow the follow-up plan, objectively describe the symptoms, and cooperate with the completion of the scale;
• Non-lactating pregnant women and no pregnancy plan during the test;
• Do not participate in any clinical trials for 3 months before and during the trial;

You may not qualify if:

• 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.)
• Patients with galactosemia;
• Pregnancy or lactation;
• Allergic to intestinal preparation drugs;
• Termination of the experiment for any other reason.

Sponsors & Collaborators

• Haifeng Lan: lead

Study Sites (1)

Jinling Hospital, China

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Interventions

Lactulose; Polyethylene Glycols

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars; Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Ji Xuan

  Jinling Hospital, China

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: graduate student

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 27, 2024
• Study Start: September 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: December 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)