Quality of Bowel PreparationNCT07674160
Effect of Simethicone on Colon Preparation During Water Exchange Colonoscopy
A study testing Simethicone with PEG and PEG in people with Quality of Bowel Preparation, run by Dalin Tzu Chi General Hospital.
Trial summary
Background: Colonoscopy reduces colorectal cancer mortality by enabling early detection and removal of adenomas. Its effectiveness, however, depends heavily on bowel preparation quality and mucosal visibility. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality of Bowel Preparation
- What is being tested?
- Simethicone with PEG and PEG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 1 Sep 2028
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Consecutive patients undergoing screening, surveillance, or diagnostic colonoscopy.
- Procedures performed by participating endoscopists.
- Ability to provide written informed consent.
Who cannot join
- Colonoscopy performed using air insufflation or water immersion technique.
- History of colorectal surgery (e.g., colectomy or colostomy).
- Known or suspected colonic obstruction or severe stricture.
- Requirement for inpatient bowel preparation.
- Known allergy or hypersensitivity to simethicone.
- Unable or unwilling to provide informed consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Simethicone on Colon Preparation in Water Exchange Colonoscopies: a Randomized Controlled Study
Background: Colonoscopy reduces colorectal cancer mortality by enabling early detection and removal of adenomas. Its effectiveness, however, depends heavily on bowel preparation quality and mucosal visibility. Simethicone, an anti-foaming agent, decreases intraluminal bubbles and improves visualization; studies in conventional air-insufflation colonoscopy generally show benefits for cleanliness and patient comfort, but evidence in water-exchange (WE) colonoscopy remains limited.Objective: To evaluate whether adding oral simethicone to a split-dose polyethylene glycol (PEG) regimen further improves bowel cleanliness and procedural performance in WE colonoscopy.Methods: Adults undergoing outpatient colonoscopy will be randomly assigned (1:1) to a simethicone group or a control group, with a planned enrollment of 180 participants. All procedures will use the WE insertion technique, and endoscopists will be blinded to group allocation. The primary endpoint is the Boston Bowel Preparation Scale (BBPS); adequate preparation is defined as a total score ≥6 with all segment scores ≥2. Secondary endpoints include bubble score and CEBuS, adenoma detection rate (ADR), polyp detection rate (PDR), cecal intubation rate and time, withdrawal time, volume of water used and flushing/irrigation metrics, and patient-reported tolerability and satisfaction.Expected Results: Compared with PEG alone, adding simethicone is expected to (1) increase the proportion of adequate BBPS preparations, (2) reduce bubble coverage, (3) maintain or potentially improve ADR/PDR, and (4) enhance patient tolerability and satisfaction.Conclusion: If effective, this intervention would provide a simple, low-cost strategy to optimize the quality of WE colonoscopy.
- Conditions
- Quality of Bowel Preparation
- Being tested
- Simethicone with PEG, PEG
- Keywords
- simethicone, Boston Bowel Preparation Scale (BBPS), bubble score, Colon Endoscopic Bubble Scale（CEBuS), adenoma detection rate (ADR), water-exchange (WE) colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simethicone with PEGDrug
All participants followed a standardized bowel preparation protocol consisting of 10 mg of bisacodyl and 2 liters of PEG solution administered in a split-dose regimen. Participants in the simethicone group additionally received 30 mL of simethicone (600 mg), with 15 mL added to each 1-liter dose of PEG solution.
PEGDrug
All participants followed a standardized bowel preparation protocol consisting of 10 mg of bisacodyl and 2 liters of PEG solution administered in a split-dose regimen.
| Study group | Role | What they receive |
|---|---|---|
| Without simethicone group | Active comparator | follow a bowel preparation protocol consisting of 10 mg of bisacodyl and 2 liters of PEG solution. Receives: Drug: PEG |
| With simethicone group | Experimental | Participants received a total of 30 mL of simethicone, with 15 mL added to each 1-liter dose of polyethylene glycol (PEG) solution in the split-dose regimen. Receives: Drug: Simethicone with PEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston bowel preparation scale (BBPS)
Bowel preparation quality assessed using the Boston Bowel Preparation Scale (BBPS). Adequate preparation is defined as a total score ≥6 with all segment scores ≥2.
Measured: At the time of colonoscopy.
Secondary outcomes (11)
Bubble score assessed using a 4-point bubble scale
Bubble score assessed during colonoscopy using a 4-point scale (0-3) for each colon segment, where higher scores indicate more bubbles.
Measured: During the colonoscopy procedure.
Colon Endoscopic Bubble Scale(CEBuS)
Bowel cleanliness assessed using the Colon Endoscopic Bubble Scale (CEBuS), categorized based on the percentage of mucosal surface obscured by bubbles (e.g., <5%, 5-50%, >50%).Higher scores indicate poorer visibility due to bubbles.
Measured: During the colonoscopy procedure.
Adenoma detection rate (ADR)
Measured: one week
Polyp detection rate (PDR)
Measured: one week
Cecal intubation rate
Proportion of procedures in which the cecum is successfully reached.
Measured: At the time of colonoscopy.
Cecal intubation time
Time from insertion to successful cecal intubation, measured in minutes.
Measured: During the colonoscopy procedure.
Withdrawal time
Time from cecal intubation to scope withdrawal, measured in minutes.
Measured: During the colonoscopy procedure.
Volume of water infused
Total volume of water infused during colonoscopy, measured in milliliters.
Measured: During the procedure.
Volume of fluid aspirated
Total volume of fluid aspirated during colonoscopy, measured in milliliters.
Measured: During the procedure
Patient-reported pain score
Pain assessed using a visual analog scale (VAS) ranging from 0 (no pain) to 10 (worst pain imaginable).
Measured: Immediately after the procedure.
Patient satisfaction score
Patient satisfaction assessed using a numeric rating scale from 0 to 10, where higher scores indicate greater satisfaction.
Measured: Immediately after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Quality of Bowel PreparationStudies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dalin Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07674160
- Sponsor's protocol ID
- A11403003
- Status last verified
- Feb 2026
- First submitted
- 3 Mar 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tongprasert S, Sobhonslidsuk A, Rattanasiri S. Improving quality of colonoscopy by adding simethicone to sodium phosphate bowel preparation. World J Gastroenterol. 2009 Jun 28;15(24):3032-7. doi: 10.3748/wjg.15.3032.
PubMed 19554657Cao RR, Wang L, Gao C, Pan JH, Yoshida EM, Li HY, Qi XS. Effect of oral simethicone on the quality of colonoscopy: A systematic review and meta-analysis of randomized controlled trials. J Dig Dis. 2022 Mar;23(3):134-148. doi: 10.1111/1751-2980.13084. Epub 2022 Mar 14.
PubMed 35075814Sun M, Yang G, Wang Y. Cleaning effect and tolerance of 16 bowel preparation regimens on adult patients before colonoscopy: a network meta-analysis. Int J Colorectal Dis. 2023 Mar 11;38(1):69. doi: 10.1007/s00384-023-04355-3.
PubMed 36905434Zhang S, Zheng D, Wang J, Wu J, Lei P, Luo Q, Wang L, Zhang B, Wang H, Cui Y, Chen M. Simethicone improves bowel cleansing with low-volume polyethylene glycol: a multicenter randomized trial. Endoscopy. 2018 Apr;50(4):412-422. doi: 10.1055/s-0043-121337. Epub 2017 Nov 13.
PubMed 29132175Joao M, Areia M, Alves S, Elvas L, Brito D, Saraiva S, Cadime AT. The Effect of Oral Simethicone in a Bowel Preparation in a Colorectal Cancer Screening Colonoscopy Setting: A Randomized Controlled Trial. GE Port J Gastroenterol. 2023 Jun 15;31(2):116-123. doi: 10.1159/000530866. eCollection 2024 Apr.
PubMed 38572443Bai Y, Fang J, Zhao SB, Wang D, Li YQ, Shi RH, Sun ZQ, Sun MJ, Ji F, Si JM, Li ZS. Impact of preprocedure simethicone on adenoma detection rate during colonoscopy: a multicenter, endoscopist-blinded randomized controlled trial. Endoscopy. 2018 Feb;50(2):128-136. doi: 10.1055/s-0043-119213. Epub 2017 Oct 6.
PubMed 28985630Moolla M, Dang JT, Shaw A, Dang TNT, Tian C, Karmali S, Sultanian R. Simethicone decreases bloating and improves bowel preparation effectiveness: a systematic review and meta-analysis. Surg Endosc. 2019 Dec;33(12):3899-3909. doi: 10.1007/s00464-019-07066-5. Epub 2019 Aug 26.
PubMed 31451919Menees SB, Elliott E, Govani S, Anastassiades C, Judd S, Urganus A, Boyce S, Schoenfeld P. The impact of bowel cleansing on follow-up recommendations in average-risk patients with a normal colonoscopy. Am J Gastroenterol. 2014 Feb;109(2):148-54. doi: 10.1038/ajg.2013.243.
PubMed 24496417Lebwohl B, Kastrinos F, Glick M, Rosenbaum AJ, Wang T, Neugut AI. The impact of suboptimal bowel preparation on adenoma miss rates and the factors associated with early repeat colonoscopy. Gastrointest Endosc. 2011 Jun;73(6):1207-14. doi: 10.1016/j.gie.2011.01.051. Epub 2011 Apr 8.
PubMed 21481857Sharma P, Burke CA, Johnson DA, Cash BD. The importance of colonoscopy bowel preparation for the detection of colorectal lesions and colorectal cancer prevention. Endosc Int Open. 2020 May;8(5):E673-E683. doi: 10.1055/a-1127-3144. Epub 2020 Apr 17.
PubMed 32355887Zauber AG, Winawer SJ, O'Brien MJ, Lansdorp-Vogelaar I, van Ballegooijen M, Hankey BF, Shi W, Bond JH, Schapiro M, Panish JF, Stewart ET, Waye JD. Colonoscopic polypectomy and long-term prevention of colorectal-cancer deaths. N Engl J Med. 2012 Feb 23;366(8):687-96. doi: 10.1056/NEJMoa1100370.
PubMed 22356322Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PubMed 33538338
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Simethicone on Colon Preparation in Water Exchange Colonoscopies: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07674160
- Acronym / sponsor ID
- A11403003
- Conditions
- Quality of Bowel Preparation
- Keywords
- simethicone, Boston Bowel Preparation Scale (BBPS), bubble score, Colon Endoscopic Bubble Scale（CEBuS), adenoma detection rate (ADR), water-exchange (WE) colonoscopy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Dalin Tzu Chi General HospitalUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 29 Jun 2026 (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.
Background: Colonoscopy reduces colorectal cancer mortality by enabling early detection and removal of adenomas. Its effectiveness, however, depends heavily on bowel preparation quality and mucosal visibility. Simethicone, an anti-foaming agent, decreases intraluminal bubbles and improves visualization; studies in conventional air-insufflation colonoscopy generally show benefits for cleanliness and patient comfort, but evidence in water-exchange (WE) colonoscopy remains limited.Objective: To evaluate whether adding oral simethicone to a split-dose polyethylene glycol (PEG) regimen further improves bowel cleanliness and procedural performance in WE colonoscopy.Methods: Adults undergoing outpatient colonoscopy will be randomly assigned (1:1) to a simethicone group or a control group, with a planned enrollment of 180 participants. All procedures will use the WE insertion technique, and endoscopists will be blinded to group allocation. The primary endpoint is the Boston Bowel Preparation Scale (BBPS); adequate preparation is defined as a total score ≥6 with all segment scores ≥2. Secondary endpoints include bubble score and CEBuS, adenoma detection rate (ADR), polyp detection rate (PDR), cecal intubation rate and time, withdrawal time, volume of water used and flushing/irrigation metrics, and patient-reported tolerability and satisfaction.Expected Results: Compared with PEG alone, adding simethicone is expected to (1) increase the proportion of adequate BBPS preparations, (2) reduce bubble coverage, (3) maintain or potentially improve ADR/PDR, and (4) enhance patient tolerability and satisfaction.Conclusion: If effective, this intervention would provide a simple, low-cost strategy to optimize the quality of WE colonoscopy.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Without simethicone group | Active comparator | Drug: PEGfollow a bowel preparation protocol consisting of 10 mg of bisacodyl and 2 liters of PEG solution. |
| With simethicone group | Experimental | Drug: Simethicone with PEGParticipants received a total of 30 mL of simethicone, with 15 mL added to each 1-liter dose of polyethylene glycol (PEG) solution in the split-dose regimen. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Consecutive patients undergoing screening, surveillance, or diagnostic colonoscopy.
- Procedures performed by participating endoscopists.
- Ability to provide written informed consent.
Key exclusion criteria (6 listed)
- Colonoscopy performed using air insufflation or water immersion technique.
- History of colorectal surgery (e.g., colectomy or colostomy).
- Known or suspected colonic obstruction or severe stricture.
- Requirement for inpatient bowel preparation.
- Known allergy or hypersensitivity to simethicone.
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 with PEGAll participants followed a standardized bowel preparation protocol consisting of 10 mg of bisacodyl and 2 liters of PEG solution administered in a split-dose regimen. Participants in the simethicone group additionally received 30 mL of simethicone (600 mg), with 15 mL added to each 1-liter dose of PEG solution. | Drug | With simethicone group |
| PEGAll participants followed a standardized bowel preparation protocol consisting of 10 mg of bisacodyl and 2 liters of PEG solution administered in a split-dose regimen. | Drug | Without simethicone group |
Primary outcome
Boston bowel preparation scale (BBPS)
Time frame: At the time of colonoscopy.
Bowel preparation quality assessed using the Boston Bowel Preparation Scale (BBPS). Adequate preparation is defined as a total score ≥6 with all segment scores ≥2.
11 secondary outcomes
Bubble score assessed using a 4-point bubble scale
Time frame: During the colonoscopy procedure.
Colon Endoscopic Bubble Scale(CEBuS)
Time frame: During the colonoscopy procedure.
Adenoma detection rate (ADR)
Time frame: one week
Polyp detection rate (PDR)
Time frame: one week
Cecal intubation rate
Time frame: At the time of colonoscopy.
Cecal intubation time
Time frame: During the colonoscopy procedure.
Withdrawal time
Time frame: During the colonoscopy procedure.
Volume of water infused
Time frame: During the procedure.
Volume of fluid aspirated
Time frame: During the procedure
Patient-reported pain score
Time frame: Immediately after the procedure.
Patient satisfaction score
Time frame: Immediately after the 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 29 Jun 2026.
- Results publication: PubMed 19554657Tongprasert S, Sobhonslidsuk A, Rattanasiri S. Improving quality of colonoscopy by adding simethicone to sodium phosphate bowel preparation. World J Gastroenterol. 2009 Jun 28;15(24):3032-7. doi: 10.3748/wjg.15.3032.
- Results publication: PubMed 35075814Cao RR, Wang L, Gao C, Pan JH, Yoshida EM, Li HY, Qi XS. Effect of oral simethicone on the quality of colonoscopy: A systematic review and meta-analysis of randomized controlled trials. J Dig Dis. 2022 Mar;23(3):134-148. doi: 10.1111/1751-2980.13084. Epub 2022 Mar 14.
- Results publication: PubMed 36905434Sun M, Yang G, Wang Y. Cleaning effect and tolerance of 16 bowel preparation regimens on adult patients before colonoscopy: a network meta-analysis. Int J Colorectal Dis. 2023 Mar 11;38(1):69. doi: 10.1007/s00384-023-04355-3.
- Results publication: PubMed 29132175Zhang S, Zheng D, Wang J, Wu J, Lei P, Luo Q, Wang L, Zhang B, Wang H, Cui Y, Chen M. Simethicone improves bowel cleansing with low-volume polyethylene glycol: a multicenter randomized trial. Endoscopy. 2018 Apr;50(4):412-422. doi: 10.1055/s-0043-121337. Epub 2017 Nov 13.
- Results publication: PubMed 38572443Joao M, Areia M, Alves S, Elvas L, Brito D, Saraiva S, Cadime AT. The Effect of Oral Simethicone in a Bowel Preparation in a Colorectal Cancer Screening Colonoscopy Setting: A Randomized Controlled Trial. GE Port J Gastroenterol. 2023 Jun 15;31(2):116-123. doi: 10.1159/000530866. eCollection 2024 Apr.
- Results publication: PubMed 28985630Bai Y, Fang J, Zhao SB, Wang D, Li YQ, Shi RH, Sun ZQ, Sun MJ, Ji F, Si JM, Li ZS. Impact of preprocedure simethicone on adenoma detection rate during colonoscopy: a multicenter, endoscopist-blinded randomized controlled trial. Endoscopy. 2018 Feb;50(2):128-136. doi: 10.1055/s-0043-119213. Epub 2017 Oct 6.
- Results publication: PubMed 31451919Moolla M, Dang JT, Shaw A, Dang TNT, Tian C, Karmali S, Sultanian R. Simethicone decreases bloating and improves bowel preparation effectiveness: a systematic review and meta-analysis. Surg Endosc. 2019 Dec;33(12):3899-3909. doi: 10.1007/s00464-019-07066-5. Epub 2019 Aug 26.
- Results publication: PubMed 24496417Menees SB, Elliott E, Govani S, Anastassiades C, Judd S, Urganus A, Boyce S, Schoenfeld P. The impact of bowel cleansing on follow-up recommendations in average-risk patients with a normal colonoscopy. Am J Gastroenterol. 2014 Feb;109(2):148-54. doi: 10.1038/ajg.2013.243.
- Results publication: PubMed 21481857Lebwohl B, Kastrinos F, Glick M, Rosenbaum AJ, Wang T, Neugut AI. The impact of suboptimal bowel preparation on adenoma miss rates and the factors associated with early repeat colonoscopy. Gastrointest Endosc. 2011 Jun;73(6):1207-14. doi: 10.1016/j.gie.2011.01.051. Epub 2011 Apr 8.
- Results publication: PubMed 32355887Sharma P, Burke CA, Johnson DA, Cash BD. The importance of colonoscopy bowel preparation for the detection of colorectal lesions and colorectal cancer prevention. Endosc Int Open. 2020 May;8(5):E673-E683. doi: 10.1055/a-1127-3144. Epub 2020 Apr 17.
- Results publication: PubMed 22356322Zauber AG, Winawer SJ, O'Brien MJ, Lansdorp-Vogelaar I, van Ballegooijen M, Hankey BF, Shi W, Bond JH, Schapiro M, Panish JF, Stewart ET, Waye JD. Colonoscopic polypectomy and long-term prevention of colorectal-cancer deaths. N Engl J Med. 2012 Feb 23;366(8):687-96. doi: 10.1056/NEJMoa1100370.
- Results publication: PubMed 33538338Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Simethicone with PEG and PEG in people with Quality of Bowel Preparation, run by Dalin Tzu Chi General Hospital.
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 6 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 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Chih -Wei Tseng (+886-5-2648000, cwtseng2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Boston bowel preparation scale (BBPS) (time frame: At the time of colonoscopy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07674160, which also lists 12 linked publications.
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 29 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.