Efficacy of Short Time Intervals in Split-Dose Bowel Preparation of Oral Sulfate Solution for Colonoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE4

Total Enrollment

448 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-15

Study Completion Date

2024-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To evaluate whether oral sulfate solution administered in a short time interval (6-8 hours) between the first and last dose of laxative is not inferior to a long time interval (10-12 hours) in bowel preparation quality.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy, Safety and Tolerability of Magnesium Sulfate With Low-volume Polyethylene Glycol for Colonoscopy Cleansing

NCT06728839

Bowel Preparation for Colonoscopy

NOT_YET_RECRUITING NA

Efficacy and Safety of Oral Sulfate Solution on Bowel Preparation for Colonoscopy

NCT05465889

Bowel Preparation for Colonoscopy

COMPLETED PHASE3

Efficacy and Tolerability of Suprep With and Without Simethicone for Routine Colonoscopy for Colorectal Cancer Screening

NCT02523911

Colorectal Cancer

WITHDRAWN NA

Comparison of Different Low Volume Solutions Prior to Colonoscopy

NCT03698474

Colonoscopy

COMPLETED PHASE4

Randomized Controlled Trail of Polyethylene Glycol vs Sodium Phosphate for Colonic Cleansing of Colonoscopy

NCT03817788

Polyethylene Glycol Sodium Phosphate

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The split-dose bowel preparation is recommended by multiple guidelines and widely used worldwide for improved bowel preparation quality, higher detection rate of colorectal lesions, and better tolerance. The effect of the time interval between the last dose of laxative and the colonoscopy on the quality of bowel preparation has been well studied, but the impact of the time interval between the first and last dose of laxative on the bowel preparation quality deserve to be explored. Oral sulfate solution administered in a short time interval can reduce sleep disturbance and hunger and is more flexible and convenient. This study aims to evaluate whether oral sulfate solution administered in a short time interval (6-8 hours) is not inferior to a long time interval (10-12 hours) on bowel preparation quality.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colonoscopy: Bowel Preparation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Short time interval group:

Bowel preparation for colonoscopy was performed using oral sulfate solution as a laxative

Group Type EXPERIMENTAL

Magnesium Sulfate，Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution

Intervention Type DRUG

OSS contained 17.5 g sodium sulfate, 3.13 g potassium sulfate, 1.6 g magnesium sulfate, and flavoring agents in an aqueous liquid form supplied in a 177 mL bottle. Dilute 177ml sodium, potassium, and magnesium sulfate oral solution to 500ml and intake 12-14 hours before colonoscopy, followed by two doses of 500ml water or clear aqueous liquid within 2 hours; Repeat the procedure 6 hours before the colonoscopy.

Standard time interval group

Bowel preparation for colonoscopy was performed using oral sulfate solution as a laxative

Group Type ACTIVE_COMPARATOR

Magnesium Sulfate，Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution

Intervention Type DRUG

OSS contained 17.5 g sodium sulfate, 3.13 g potassium sulfate, 1.6 g magnesium sulfate, and flavoring agents in an aqueous liquid form supplied in a 177 mL bottle. Dilute 177ml sodium, potassium, and magnesium sulfates oral solution to 500ml and intake 16-18 hours before the colonoscopy, followed by two doses of 500ml water or clear aqueous liquid within 2 hours; Repeat the procedure 6 hours before the colonoscopy.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Magnesium Sulfate，Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution

OSS contained 17.5 g sodium sulfate, 3.13 g potassium sulfate, 1.6 g magnesium sulfate, and flavoring agents in an aqueous liquid form supplied in a 177 mL bottle. Dilute 177ml sodium, potassium, and magnesium sulfate oral solution to 500ml and intake 12-14 hours before colonoscopy, followed by two doses of 500ml water or clear aqueous liquid within 2 hours; Repeat the procedure 6 hours before the colonoscopy.

Intervention Type DRUG

Magnesium Sulfate，Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution

OSS contained 17.5 g sodium sulfate, 3.13 g potassium sulfate, 1.6 g magnesium sulfate, and flavoring agents in an aqueous liquid form supplied in a 177 mL bottle. Dilute 177ml sodium, potassium, and magnesium sulfates oral solution to 500ml and intake 16-18 hours before the colonoscopy, followed by two doses of 500ml water or clear aqueous liquid within 2 hours; Repeat the procedure 6 hours before the colonoscopy.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Voluntarily participate and sign informed consent;
* Subjects who require screening, surveillance, and diagnostic colonoscopy;
* Subjects who take the oral sulfate solution for bowel preparation.

Exclusion Criteria

* Subjects with serious cardiac and cerebrovascular diseases, bronchial and lung diseases, suffering from metabolic disease or endocrine disease, abnormal blood clotting mechanism, malignant tumor, electrolyte abnormalities, epilepsy, renal or liver dysfunction;
* Subjects with ascites, suspected electrolyte abnormalities, or uncorrected dehydration.
* Subjects with confirmed or suspected gastrointestinal obstruction, gastric retention, gastroparesis, gastric emptying disorder, or acute gastrointestinal bleeding;
* Subjects with confirmed or suspected colorectal cancer, inflammatory bowel disease, toxic colitis, or toxic megacolon.
* Subjects who had previously undergone colorectal resection.
* Subjects with constipation or suspected severe gastric motility disorder;
* Women with positive pregnancy tests or pregnancy plans, and women in lactation;
* Subjects who have participated in any other clinical trials within the last 3 months;
* Subjects with any other conditions that the investigator considered inappropriate for inclusion.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes