Colonoscopy: Bowel PreparationPhase 4NCT06317597
Efficacy of Short Time Intervals in Split-Dose Bowel Preparation of Oral Sulfate Solution for Colonoscopy
A Phase 4 study testing Magnesium Sulfate，Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution in people with Colonoscopy: Bowel Preparation, run by Changhai Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy: Bowel Preparation
- What is being tested?
- Magnesium Sulfate，Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 448 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2024to 30 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Voluntarily participate and sign informed consent;
- Subjects who require screening, surveillance, and diagnostic colonoscopy;
- Subjects who take the oral sulfate solution for bowel preparation.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Colonoscopy: Bowel Preparation
- Being tested
- Magnesium Sulfate，Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution
- Keywords
- time interval, bowel preparation, Oral Sulfate Solution（OSS）
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium Sulfate，Sodium Sulfate and Potassium Sulfate Concentrate Oral SolutionDrug
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.
Magnesium Sulfate，Sodium Sulfate and Potassium Sulfate Concentrate Oral SolutionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Short time interval group: | Experimental | Bowel preparation for colonoscopy was performed using oral sulfate solution as a laxative Receives: 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 Receives: Drug: Magnesium Sulfate，Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30minutes
Secondary outcomes (1)
Acceptability of bowel preparation by questionnaire survey
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start15 Mar 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonoscopy: Bowel PreparationStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 448 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University People's Hospital, Tianjin Medical University General Hospital, The Affiliated Suzhou Hospital of Nanjing Medical University, Tianjin First Central Hospital, Tianjin Beichen Hospital, Shandong Provincial Hospital, The Affiliated Hospital of Qingdao University, First People's Hospital of Hangzhou, The Third People's Hospital of Chengdu, Ningbo Yinzhou District Second Hospital, Changshu Affiliated Hospital of Soochow University, Linyi People's Hospital, Shanghai East Hospital, Heilongjiang Province Hospital Nangang Branch, The Affiliated Jiangyin Hospital of Nantong University, West China Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06317597
- Sponsor's protocol ID
- OSS2024-0311
- Status last verified
- Mar 2024
- First submitted
- 6 Mar 2024
- Last updated
- 19 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Short Time Intervals in Split-Dose Bowel Preparation of Oral Sulfate Solution: A Multicenter, Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06317597
- Acronym / sponsor ID
- OSS2024-0311
- Conditions
- Colonoscopy: Bowel Preparation
- Keywords
- time interval, bowel preparation, Oral Sulfate Solution（OSS）
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 448 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- Peking University People's Hospital, Tianjin Medical University General Hospital, The Affiliated Suzhou Hospital of Nanjing Medical University, Tianjin First Central Hospital, Tianjin Beichen Hospital, Shandong Provincial Hospital, The Affiliated Hospital of Qingdao University, First People's Hospital of Hangzhou, The Third People's Hospital of Chengdu, Ningbo Yinzhou District Second Hospital, Changshu Affiliated Hospital of Soochow University, Linyi People's Hospital, Shanghai East Hospital, Heilongjiang Province Hospital Nangang Branch, The Affiliated Jiangyin Hospital of Nantong University, West China Hospital
- Study start
- 15 Mar 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 19 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short time interval group: | Experimental | Drug: Magnesium Sulfate，Sodium Sulfate and Potassium Sulfate Concentrate Oral SolutionBowel preparation for colonoscopy was performed using oral sulfate solution as a laxative |
| Standard time interval group | Active comparator | Drug: Magnesium Sulfate，Sodium Sulfate and Potassium Sulfate Concentrate Oral SolutionBowel preparation for colonoscopy was performed using oral sulfate solution as a laxative |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Voluntarily participate and sign informed consent;
- Subjects who require screening, surveillance, and diagnostic colonoscopy;
- Subjects who take the oral sulfate solution for bowel preparation.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium Sulfate，Sodium Sulfate and Potassium Sulfate Concentrate Oral SolutionOSS 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 | Short time interval group: |
| Magnesium Sulfate，Sodium Sulfate and Potassium Sulfate Concentrate Oral SolutionOSS 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. | Drug | Standard time interval group |
Primary outcome
Bowel preparation adequate rate
Time frame: 30minutes
Adequate bowel cleansing was defined as a total Boston Bowel Preparation Scale (BBPS) ≥ 6 with a partial BBPS ≥ 2 in each colon segment.
1 secondary outcome
Acceptability of bowel preparation by questionnaire survey
Time frame: 12 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Magnesium Sulfate，Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution in people with Colonoscopy: Bowel Preparation, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bowel preparation adequate rate (time frame: 30minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.