SimethiconePhase 4NCT06812832
Simethicone as Part of ERAS in Bariatric Surgery Patients
A Phase 4 study testing Simethicone 80 MG in people with Simethicone and Bariatric Surgery, run by Madigan Army Medical Center at 1 site in United States.
Trial summary
By conducting this study, we hope to assess if simethicone (also known as Gas Relief or GasX) has an effect on improving gas pain and bloating specifically in patients undergoing foregut procedures to include bariatric procedures (sleeve gastrectomy, Roux-en-Y gastric bypass), hiatal hernia, and gastric surgery. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Simethicone, Bariatric Surgery, Post-operative Pain
- What is being tested?
- Simethicone 80 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2025to Mar 2029
- 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 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Foregut procedures
Who cannot join
- Non-foregut procedures
- Allergy to simethicone
- Pregnancy or breastfeeding
- Minors under 18 years of age
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Madigan Army Medical Center
Tacoma, Washington, 98431
Christopher Porta, MD, 253-968-3105, christopher.r.porta.civ@health.mil
About this study
Official title: Simethicone as Part of an Enhanced Recovery After Surgery (ERAS) Protocol
By conducting this study, we hope to assess if simethicone (also known as Gas Relief or GasX) has an effect on improving gas pain and bloating specifically in patients undergoing foregut procedures to include bariatric procedures (sleeve gastrectomy, Roux-en-Y gastric bypass), hiatal hernia, and gastric surgery.
The purpose of this research is to gather information on the safety and effectiveness of simethicone. Simethicone (more commonly known as Gas Relief or Gas-X) relieves pressure, bloating, and fullness commonly referred to as gas. It is FDA approved. The use of this medication in this research study is consistent with labeling indications.
Read the detailed description
Patient enrollment Prospective participants will be screened prior to their preoperative appointment based on their presenting complaint (diagnosis) and the indicated surgical procedure (foregut operations).
Patients will undergo informed consent by a member of the research team. Patients will complete baseline survey (PROMIS Scale v1.1 - Gastrointestinal Gas and Bloating 13). This is a paper survey that will be provided to them by a member of the research team.
Patient randomization Patients will be randomized into simethicone vs placebo groups via unrestricted randomization The research pharmacist and DCI statistician will be the only individuals who know if a patient is in the experimental (simethicone) group or the control (placebo) group.
Patients will undergo their surgical procedure Postoperatively, all patients will be ordered to receive either simethicone at 80mg or placebo prepared by research pharmacist based on randomziation scheme four times per day. The research pharmacist will have the appropriate patient randomization via MRN or FIN and will provide either simethicone or placebo.
24 hours postoperatively, patients will recomplete the PROMIS Scale v1.1 - Gastrointestinal Gas and Bloating 13a for comparison as well as complete the APS Patient Outcome Questionnaire (APS-POQ-R) survey. Both of these are paper surveys that will be provided to them.
If patients are admitted for greater than 1 night, they will complete the surveys every 24 hours until discharge. These are paper surveys that will be provided to them.
Patients will be discharged with simethicone for a total of a 14 day course (to include their inpatient doses, 56 doses total) until their follow up appointment. Patients assigned to the placebo group will receive placebo (56 doses). The total number of doses any patient will receive, regardless of the length of their inpatient stay, is 56 doses. This is the number of doses total for a 14 day course when taking the medication four times per day.
At their standard postoperatively follow up visit, patients will re-complete their (PROMIS Scale v1.1 - Gastrointestinal Gas and Bloating 13a). They will also complete a compliance survey. These are both paper surveys that will be provided to them.
Data will be collected into master data sheet and data will then be de-identified with pseudo-ID assigned according to the Master Key spreadsheet. The randomization spreadsheet will only be accessed by the research pharmacist and the DCI statistician.
The master key will be kept under CAC-enabled protection The de-identified data will then be collated and analyzed Data will then be reported and submitted for relevant conferences The entirety of this project will take 4 years following IRB approval, 3 years for enrollment, perhaps an additional 1 year of data collection/analysis.
- Conditions
- Simethicone, Bariatric Surgery, Post-operative Pain
- Being tested
- Simethicone 80 MG, Placebo
- Keywords
- Simethicone, Gas-X, Foregut, Post-operative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simethicone 80 MGDrug
Patients will receive simethicone 80mg four times per day for 2 weeks post-operatively.
PlaceboDrug
Patients in the control group will receive a placebo pill four times per day for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Placebo comparator | This arm will receive the placebo pill Receives: Drug: Placebo |
| Experimental Arm | Experimental | This arm will receive simethicone Receives: Drug: Simethicone 80 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Postoperative pain score - based on patient completion of the APS Patient Outcome Questionnaire (APS-POQ-R). Scores are (1) pain severity and relief; (2) impact of pain on activity, sleep, and negative emotions; (3) side effects of treatment; (4) helpfulness of information about pain treatment; (5) ability to participate in pain treatment decisions; and (6) use of nonpharmacological strategies. 0 is no pain and 10 is severe/worst pain possible. Low scores are better outcomes.
Measured: From enrollment through two weeks postoperatively
Opioid Use
Opioid use - measured via oral morphine equivalents based on chart review and post-operative survey with patient stated opioid use after discharge
Measured: Immediate post-operatively (in PACU) through 2 weeks postoperatively
Gas and Bloating Score
PROMIS Scale v1.0 - Gastrointestinal Reflux 13a. The PROMIS Gastrointestinal Gas and Bloating Scale includes 13 items that assess the frequency, intensity, and severity of various gastrointestinal symptoms. More specifically, the items address bloating(i.e., feeling pressure or fullness), bloating appearance (i.e., belly swollen or larger than usual size), flatulence (i.e., passing gas), and abdominal sounds (i.e., gurgling or rumbling), as well as the predictability, bothersomeness, and interference with daily activities that result from these symptoms. This measure is not disease-specific and is intended for adult respondents (ages 18+). Scores are 1-5, with 1 being "Never" and 5 being "Very Much." Low scores are better outcomes.
Measured: From enrollment to 14 days post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start8 Apr 2025
- Primary completionMar 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SimethiconeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Madigan Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06812832
- Sponsor's protocol ID
- 971532
- Status last verified
- Jan 2025
- First submitted
- 31 Jan 2025
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simethicone as Part of an Enhanced Recovery After Surgery (ERAS) Protocol
- ClinicalTrials.gov ID
- NCT06812832
- Acronym / sponsor ID
- 971532
- Conditions
- Simethicone, Bariatric Surgery, Post-operative Pain
- Keywords
- Simethicone, Gas-X, Foregut, Post-operative pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Madigan Army Medical CenterUS federal agency
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 6 Feb 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.
By conducting this study, we hope to assess if simethicone (also known as Gas Relief or GasX) has an effect on improving gas pain and bloating specifically in patients undergoing foregut procedures to include bariatric procedures (sleeve gastrectomy, Roux-en-Y gastric bypass), hiatal hernia, and gastric surgery.
The purpose of this research is to gather information on the safety and effectiveness of simethicone. Simethicone (more commonly known as Gas Relief or Gas-X) relieves pressure, bloating, and fullness commonly referred to as gas. It is FDA approved. The use of this medication in this research study is consistent with labeling indications.
Detailed description
Patient enrollment Prospective participants will be screened prior to their preoperative appointment based on their presenting complaint (diagnosis) and the indicated surgical procedure (foregut operations).
Patients will undergo informed consent by a member of the research team. Patients will complete baseline survey (PROMIS Scale v1.1 - Gastrointestinal Gas and Bloating 13). This is a paper survey that will be provided to them by a member of the research team.
Patient randomization Patients will be randomized into simethicone vs placebo groups via unrestricted randomization The research pharmacist and DCI statistician will be the only individuals who know if a patient is in the experimental (simethicone) group or the control (placebo) group.
Patients will undergo their surgical procedure Postoperatively, all patients will be ordered to receive either simethicone at 80mg or placebo prepared by research pharmacist based on randomziation scheme four times per day. The research pharmacist will have the appropriate patient randomization via MRN or FIN and will provide either simethicone or placebo.
24 hours postoperatively, patients will recomplete the PROMIS Scale v1.1 - Gastrointestinal Gas and Bloating 13a for comparison as well as complete the APS Patient Outcome Questionnaire (APS-POQ-R) survey. Both of these are paper surveys that will be provided to them.
If patients are admitted for greater than 1 night, they will complete the surveys every 24 hours until discharge. These are paper surveys that will be provided to them.
Patients will be discharged with simethicone for a total of a 14 day course (to include their inpatient doses, 56 doses total) until their follow up appointment. Patients assigned to the placebo group will receive placebo (56 doses). The total number of doses any patient will receive, regardless of the length of their inpatient stay, is 56 doses. This is the number of doses total for a 14 day course when taking the medication four times per day.
At their standard postoperatively follow up visit, patients will re-complete their (PROMIS Scale v1.1 - Gastrointestinal Gas and Bloating 13a). They will also complete a compliance survey. These are both paper surveys that will be provided to them.
Data will be collected into master data sheet and data will then be de-identified with pseudo-ID assigned according to the Master Key spreadsheet. The randomization spreadsheet will only be accessed by the research pharmacist and the DCI statistician.
The master key will be kept under CAC-enabled protection The de-identified data will then be collated and analyzed Data will then be reported and submitted for relevant conferences The entirety of this project will take 4 years following IRB approval, 3 years for enrollment, perhaps an additional 1 year of data collection/analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Placebo comparator | Drug: PlaceboThis arm will receive the placebo pill |
| Experimental Arm | Experimental | Drug: Simethicone 80 MGThis arm will receive simethicone |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Foregut procedures
Key exclusion criteria (4 listed)
- Non-foregut procedures
- Allergy to simethicone
- Pregnancy or breastfeeding
- Minors under 18 years of age
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 80 MGPatients will receive simethicone 80mg four times per day for 2 weeks post-operatively. | Drug | Experimental Arm |
| PlaceboPatients in the control group will receive a placebo pill four times per day for 2 weeks | Drug | Control Arm |
Primary outcome
Pain
Time frame: From enrollment through two weeks postoperatively
Postoperative pain score - based on patient completion of the APS Patient Outcome Questionnaire (APS-POQ-R). Scores are (1) pain severity and relief; (2) impact of pain on activity, sleep, and negative emotions; (3) side effects of treatment; (4) helpfulness of information about pain treatment; (5) ability to participate in pain treatment decisions; and (6) use of nonpharmacological strategies. 0 is no pain and 10 is severe/worst pain possible. Low scores are better outcomes.
Opioid Use
Time frame: Immediate post-operatively (in PACU) through 2 weeks postoperatively
Opioid use - measured via oral morphine equivalents based on chart review and post-operative survey with patient stated opioid use after discharge
Gas and Bloating Score
Time frame: From enrollment to 14 days post-operatively
PROMIS Scale v1.0 - Gastrointestinal Reflux 13a. The PROMIS Gastrointestinal Gas and Bloating Scale includes 13 items that assess the frequency, intensity, and severity of various gastrointestinal symptoms. More specifically, the items address bloating(i.e., feeling pressure or fullness), bloating appearance (i.e., belly swollen or larger than usual size), flatulence (i.e., passing gas), and abdominal sounds (i.e., gurgling or rumbling), as well as the predictability, bothersomeness, and interference with daily activities that result from these symptoms. This measure is not disease-specific and is intended for adult respondents (ages 18+). Scores are 1-5, with 1 being "Never" and 5 being "Very Much." Low scores are better outcomes.
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 15 Jun 2025.
- 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.
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 80 MG in people with Simethicone and Bariatric Surgery, run by Madigan Army Medical Center at 1 site in United States.
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 4 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: looking for participants now, as of the sponsor's last update on 15 Jun 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 United States. 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. Some participants in this study may receive a placebo. 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 Brooklyn Williams, DO ((253) 968-3105, brooklyn.c.williams3.mil@health.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: From enrollment through two weeks postoperatively). The study lists 3 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 15 Jun 2025.