Clinical Study of Bowel Preparation Before Colonoscopy

NCT06091735 | Completed

• 1 other identifier: DZQH-KYLL-23-11
• Study Type: interventional
• Target: 444
• Locations: 1 country
• Sites: 1

Brief Summary

This study was a single-center, randomized controlled clinical study. Subjects meeting the inclusion criteria will be randomly assigned to magnesium sodium potassium sulfate oral concentrated solution group, magnesium sodium potassium sulfate oral concentrated solution + linaclotide group, PEG group in equal proportion.

Conditions

Bowel Preparation

Outcome Measures

Primary Outcomes (1)

• BBPS

  The proportion of subjects with an overall Boston score ≥6 and a colon score ≥2 for each segment was considered valid.

  1day

Study Arms (3)

Magnesium sulfate sodium potassium solution group

EXPERIMENTAL

Magnesium sulfate sodium potassium solution group: 3L magnesium sulfate sodium potassium oral concentrated solution. At 18:00 1d before the inspection, dissolve a package of contents into 200ml with water, and drink 250ml of water every half hour after that, drinking a total of 6 cups (that is, 1.5L); On the day of the examination (6 hours before the colonoscopy) repeat the same medication as the previous evening.

Drug: OSS

Magnesium sulfate sodium potassium solution group + linaclotide group

EXPERIMENTAL

Magnesium sulfate sodium potassium solution + linaclotide group: 3L sodium magnesium sulfate potassium oral concentrated solution + linaclotide 290μg. One tablet of linalotide was taken orally at 18:00 one day before the examination, and then two packets of contents were dissolved into 300ml with water 6 hours before the colonoscopy. After that, 500ml of water was drunk every half hour, for a total of 6 cups.

Drug: OSS+Linzess

PEG (Compound polyethylene glycol electrolyte powder) group

PLACEBO COMPARATOR

PEG (Compound polyethylene glycol electrolyte powder) group: 3LPEG. At 18:00 1d before the inspection, dissolve a package of contents into 200ml with water, and drink 250ml of water every half hour after that, drinking a total of 6 cups; On the day of the examination (6 hours before the colonoscopy) repeat the same medication as the previous evening.

Drug: PEG-Interferon Alfa

Interventions

OSS DRUG

experimental

Also known as: Sodium potassium magnesium sulfate oral concentrated solution

Magnesium sulfate sodium potassium solution group

OSS+Linzess DRUG

experimental

Also known as: sodium potassium magnesium sulfate oral concentrated solution + linaclotide

Magnesium sulfate sodium potassium solution group + linaclotide group

PEG-Interferon Alfa DRUG

Placebo Comparator

Also known as: PEG

PEG (Compound polyethylene glycol electrolyte powder) group

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;
• Participate voluntarily and sign informed consent.

You may not qualify if:

• NYHA cardiac function grade III or IV;
• Unstable angina pectoris in the convalescence period of acute myocardial infarction or in the near future;
• have serious liver and kidney function diseases;
• Suspected gastrointestinal obstruction or gastrointestinal perforation;
• Pregnant or lactating women;
• Mental illness or physical dysfunction can not cooperate with the examination;
• People who are allergic to intestinal preparation drugs.
• Patients who did not undergo colonoscopy after bowel clearing due to their own reasons;
• Patients who can not tolerate general colonoscopy and terminate the examination;
• Patients who requested withdrawal from the study.

Sponsors & Collaborators

• Jinling Hospital, China: lead

Study Sites (1)

A single-center, single-blind, randomized controlled clinical study of bowel preparation before colonoscopy

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Interventions

linaclotide

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: student

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 19, 2023
• Study Start: August 1, 2023
• Primary Completion: February 25, 2024
• Study Completion: February 25, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)