Simethicone to reduce gas pain after foregut and bariatric surgery
Official title: Simethicone as Part of an Enhanced Recovery After Surgery (ERAS) Protocol
Run by Madigan Army Medical Center · NCT06812832 · Data updated 2026-11-12
This trial will test whether simethicone (Gas-X) reduces gas pain and bloating in adults having foregut operations such as sleeve gastrectomy or gastric bypass.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Enrollment | 260 (estimated) |
| Sponsor | Madigan Army Medical Center Federal |
| Locations | 1 site (Tacoma, Washington) |
| Status | Recruiting |
| Started | April 8, 2025 |
| Main results expected | March 2028 |
| Study ends | March 2029 |
| Registry record updated | June 15, 2025 |
| Trial ID | NCT06812832 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults scheduled for foregut operations (including sleeve gastrectomy, Roux-en-Y gastric bypass, hiatal hernia, or other gastric surgery) who are not pregnant and do not have a simethicone allergy are eligible.
✕Probably not a fit
Patients having non-foregut procedures, minors under 18, pregnant or breastfeeding individuals, or those allergic to simethicone are unlikely to receive benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center, randomized, placebo-controlled Phase 4 trial enrolls adult patients undergoing foregut procedures at Madigan Army Medical Center. Participants complete a baseline PROMIS Gastrointestinal Gas and Bloating survey, are randomized to receive either simethicone 80 mg or placebo four times daily after surgery, and repeat the PROMIS survey and the APS-POQ-R pain questionnaire 24 hours postoperatively (and daily if admitted longer). The research pharmacist and study statistician are the only unblinded personnel, and all other team members and patients are blinded to allocation. The study is designed to gather safety data and measure symptomatic benefit of simethicone in the immediate postoperative period.
Why it matters
Potential benefit: If successful, patients may have less postoperative gas pain and bloating, leading to greater comfort and an easier early recovery.
How similar studies have gone: Simethicone is an established over-the-counter remedy for gas, but randomized trials specifically targeting postoperative foregut patients are limited, so this application is relatively understudied.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Foregut procedures Exclusion Criteria: * Non-foregut procedures * Allergy to simethicone * Pregnancy or breastfeeding * Minors under 18 years of age
Where it's running
-
Madigan Army Medical Center
Tacoma, Washington, United States Recruiting
Study contacts
- Study coordinator: Brooklyn Williams, DO
- Email: brooklyn.c.williams3.mil@health.mil
- Phone: (253) 968-3105
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.