ColonoscopyPhase 4NCT06919120
The Study on the Effect of Different Administration Methods of Simethicone in Reducing Bubbles During Bowel Preparation
A Phase 4 study testing Simethicone is mixed into the final packet of compound polyethylene glycol electrolyte powder and Take simethicone separately in people with Colonoscopy, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
To find the simplest and most effective method of intestinal preparation for dimethicone administration. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colonoscopy
- What is being tested?
- Simethicone is mixed into the final packet of compound polyethylene glycol electrolyte powder and Take simethicone separately
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 31 Oct 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing routine colonoscopy at our hospital are aged between 18 to 80 years, including those who meet the Indications for colonoscopy without any absolute contraindications.
Who cannot join
- （１） suffering from pancoliنى, intestinal obstruction, toxic megacolon, severe acute gastrointestinal infection, etc.; （２） individuals with severe dysfunction of the heart, lungs, liver, kidneys, etc.; （３） individuals with a history of allergic reaction to the above gastrointestinal agents; （４） individuals who cannot consent to treatment for epilepsy, etc.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
the Fourth Affiliated Hospital of Zhejiang University
Yiwu, Zhejiang
About this study
To find the simplest and most effective method of intestinal preparation for dimethicone administration.
Read the detailed description
A randomized controlled trial of dimethicone mixed with compound polyethylene glycol electrolyte powder (group A) versus dimethicone alone was conducted in patients undergoing colonoscopy (group B) the two different administration methods were used to compare the defoaming effect of dimethicone and the detection rate of polyps ≤0.5cm. To find the best way to administer dimethicone during bowel preparation for colonoscopy.
In group A (n = 686), a bottle of dimethicone was mixed with the last package of compound polyethylene glycol electrolyte powder, dissolved in 1000ml water, and finished within 1 hour during bowel preparation.
Group B (n = 686) received a bottle of dimethicone after taking the last sip of compound polyethylene glycol electrolyte powder.
Investigators asked each patient and physician about the interval between the administration of dimethicone and the initiation of colonoscopy, the time to colonoscopy withdrawal, the bowel cleanliness score, the intestinal bubble score, and whether polyps ≤0.5cm in diameter were detected.
SPSS25.0 was used to analyze the data with two independent samples t test. The gender, age, the interval between the end of antifoams and the start of the examination, the time of withdrawal from colonoscopy during the examination, the intestinal cleanliness score, the intestinal bubble score, and the detection of polyps with diameter ≤0.5cm were analyzed between group A (dimethicone mixed with compound polyethylene glycol electrolyte powder) and group B (dimethicone alone).
- Conditions
- Colonoscopy
- Being tested
- Simethicone is mixed into the final packet of compound polyethylene glycol electrolyte powder, Take simethicone separately
- Keywords
- Dimethicone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simethicone is mixed into the final packet of compound polyethylene glycol electrolyte powderDrug
The patients added one bottle of simethicone when taking the final packet of compound polyethylene glycol electrolyte powder.
Take simethicone separatelyDrug
Take one bottle of simethicone orally after finishing the last sip of compound polyethylene glycol electrolyte solution.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | The patients in this group mixed one bottle of simethicone into the final packet of compound polyethylene glycol electrolyte powder, dissolved it in 1000 ml of water, and consumed it within one hour. Receives: Drug: Simethicone is mixed into the final packet of compound polyethylene glycol electrolyte powder |
| B | Experimental | The patients in this group took one bottle of simethicone orally after finishing the last sip of compound polyethylene glycol electrolyte solution. Receives: Drug: Take simethicone separately |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston Bowel Preparation Scale
Bowel cleanliness was assessed using the Boston Bowel Preparation Scale (BBPS) in both groups, and the efficacy of bowel cleansing was compared between the two medication regimens to identify potential differences
Measured: During the colonoscopy procedure
Intestinal Bubble Score
Bowel foam levels were assessed using the Intestinal Bubble Score (IBS) in both groups, and the efficacy of foam clearance was compared between the two medication regimens to identify potential differences
Measured: During the colonoscopy procedure
Secondary outcomes (1)
Detection rate of polyps
The detection rate of polyps ≤0.5 cm was compared between the two groups
Measured: During the colonoscopy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06919120
- Sponsor's protocol ID
- KY-2024-227
- Status last verified
- Dec 2024
- First submitted
- 2 Apr 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study on the Effect of Different Administration Methods of Simethicone in Reducing Bubbles During Bowel Preparation
- ClinicalTrials.gov ID
- NCT06919120
- Acronym / sponsor ID
- KY-2024-227
- Conditions
- Colonoscopy
- Keywords
- Dimethicone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 9 Apr 2025 (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 find the simplest and most effective method of intestinal preparation for dimethicone administration.
Detailed description
A randomized controlled trial of dimethicone mixed with compound polyethylene glycol electrolyte powder (group A) versus dimethicone alone was conducted in patients undergoing colonoscopy (group B) the two different administration methods were used to compare the defoaming effect of dimethicone and the detection rate of polyps ≤0.5cm. To find the best way to administer dimethicone during bowel preparation for colonoscopy.
In group A (n = 686), a bottle of dimethicone was mixed with the last package of compound polyethylene glycol electrolyte powder, dissolved in 1000ml water, and finished within 1 hour during bowel preparation.
Group B (n = 686) received a bottle of dimethicone after taking the last sip of compound polyethylene glycol electrolyte powder.
Investigators asked each patient and physician about the interval between the administration of dimethicone and the initiation of colonoscopy, the time to colonoscopy withdrawal, the bowel cleanliness score, the intestinal bubble score, and whether polyps ≤0.5cm in diameter were detected.
SPSS25.0 was used to analyze the data with two independent samples t test. The gender, age, the interval between the end of antifoams and the start of the examination, the time of withdrawal from colonoscopy during the examination, the intestinal cleanliness score, the intestinal bubble score, and the detection of polyps with diameter ≤0.5cm were analyzed between group A (dimethicone mixed with compound polyethylene glycol electrolyte powder) and group B (dimethicone alone).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Simethicone is mixed into the final packet of compound polyethylene glycol electrolyte powderThe patients in this group mixed one bottle of simethicone into the final packet of compound polyethylene glycol electrolyte powder, dissolved it in 1000 ml of water, and consumed it within one hour. |
| B | Experimental | Drug: Take simethicone separatelyThe patients in this group took one bottle of simethicone orally after finishing the last sip of compound polyethylene glycol electrolyte solution. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing routine colonoscopy at our hospital are aged between 18 to 80 years, including those who meet the Indications for colonoscopy without any absolute contraindications.
Key exclusion criteria (1 listed)
- （１） suffering from pancoliنى, intestinal obstruction, toxic megacolon, severe acute gastrointestinal infection, etc.; （２） individuals with severe dysfunction of the heart, lungs, liver, kidneys, etc.; （３） individuals with a history of allergic reaction to the above gastrointestinal agents; （４） individuals who cannot consent to treatment for epilepsy, etc.
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 |
|---|---|---|
| Simethicone is mixed into the final packet of compound polyethylene glycol electrolyte powderThe patients added one bottle of simethicone when taking the final packet of compound polyethylene glycol electrolyte powder. | Drug | A |
| Take simethicone separatelyTake one bottle of simethicone orally after finishing the last sip of compound polyethylene glycol electrolyte solution. | Drug | B |
Primary outcome
Boston Bowel Preparation Scale
Time frame: During the colonoscopy procedure
Bowel cleanliness was assessed using the Boston Bowel Preparation Scale (BBPS) in both groups, and the efficacy of bowel cleansing was compared between the two medication regimens to identify potential differences
Intestinal Bubble Score
Time frame: During the colonoscopy procedure
Bowel foam levels were assessed using the Intestinal Bubble Score (IBS) in both groups, and the efficacy of foam clearance was compared between the two medication regimens to identify potential differences
1 secondary outcome
Detection rate of polyps
Time frame: During the colonoscopy procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
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 Simethicone is mixed into the final packet of compound polyethylene glycol electrolyte powder and Take simethicone separately in people with Colonoscopy, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 9 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Linzhen Zhu, Bachelor (15958902187, 1504152@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Boston Bowel Preparation Scale (time frame: During the colonoscopy procedure). The study lists 2 primary outcomes in all. 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 9 Apr 2025.