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

NCT06317597 | Enrolling By Invitation Phase 4

• 1 other identifier: OSS2024-0311
• Study Type: interventional
• Target: 448
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colonoscopy: Bowel Preparation

Keywords

time interval; bowel preparation; Oral Sulfate Solution（OSS）

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Acceptability of bowel preparation by questionnaire survey

  12 hours

Other Outcomes (2)

• Incidence of laxative-related adverse events assessed by clinical examinations

  8 days

• Colonoscopy completion rate

  30 minutes

Study Arms (2)

Short time interval group:

EXPERIMENTAL

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

Drug: Magnesium Sulfate，Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution

Standard time interval group

ACTIVE COMPARATOR

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

Drug: Magnesium Sulfate，Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution

Interventions

Magnesium Sulfate，Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution 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.

Short time interval group:

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

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

Study Sites (1)

Changhai Hospital

Shanghai, China

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 19, 2024
• Study Start: March 15, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 30, 2024
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)