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

Evaluating the Efficacy of Short Time Intervals in Split-Dose Bowel Preparation of Oral Sulfate Solution: A Multicenter, Prospective, Randomized Controlled Trial

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Colonoscopy: Bowel Preparation
• Intervention / Treatment: Drug: Magnesium Sulfate，Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution; Drug: Magnesium Sulfate，Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 448
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Changhai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Short time interval group: Bowel preparation for colonoscopy was performed using oral sulfate solution as a laxative	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 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.; 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.
Active Comparator: Standard time interval group; Bowel preparation for colonoscopy was performed using oral sulfate solution as a laxative	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 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bowel preparation adequate rate	Adequate bowel cleansing was defined as a total Boston Bowel Preparation Scale (BBPS) ≥ 6 with a partial BBPS ≥ 2 in each colon segment.	30minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Acceptability of bowel preparation by questionnaire survey	12 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Colonoscopy completion rate	Proportion of subjects receiving complete colonoscopy	30 minutes
Incidence of laxative-related adverse events assessed by clinical examinations		8 days

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Collaborators: First People's Hospital of Hangzhou; Peking University People's Hospital; West China Hospital; The Affiliated Hospital of Qingdao University; Shanghai East Hospital; Tianjin First Central Hospital; Linyi People's Hospital; The Third People's Hospital of Chengdu; Tianjin Beichen Hospital; Changshu Affiliated Hospital of Soochow University; Internet Hospital of Tianjin Medical University General Hospital; The Affiliated Suzhou Hospital of Nanjing Medical University; ShangDong Provincial Hospital; Ningbo Yinzhou District Second Hospital; Heilongjiang Province Hospital Nangang Branch; The Affiliated Jiangyin Hospital of Nantong University

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: March 6, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: bowel preparation; time interval; Oral Sulfate Solution（OSS）
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Gastrointestinal Agents; Membrane Transport Modulators; Anticonvulsants; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Cathartics; Tocolytic Agents; Pharmaceutical Solutions; Magnesium Sulfate; Sodium sulfate
• Other Study ID Numbers: OSS2024-0311

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No