Recruiting

Simethicone

Sponsor:

Madigan Army Medical Center

Code:

NCT06812832

Conditions

Simethicone

Bariatric Surgery

Post-operative Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Simethicone 80 MG

Placebo

Study Details

Brief 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.

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.

Conditions

Simethicone

Bariatric Surgery

Post-operative Pain

Study ID

NCT06812832

Start date

Apr 8, 2025

Status verified date

Jan, 2025

Completion date

Mar, 2029

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Foregut procedures

Exclusion Criteria:

  • Non-foregut procedures
  • Allergy to simethicone
  • Pregnancy or breastfeeding
  • Minors under 18 years of age

Study Design

Enrollment

260 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Control Arm

This arm will receive the placebo pill

experimental: Experimental Arm

This arm will receive simethicone

Interventions

Simethicone 80 MG

Patients will receive simethicone 80mg four times per day for 2 weeks post-operatively.

Placebo

Patients in the control group will receive a placebo pill four times per day for 2 weeks

Primary outcome measure

  • Pain [ Time Frame: From enrollment through two weeks postoperatively ]
  • Opioid Use [ Time Frame: Immediate post-operatively (in PACU) through 2 weeks postoperatively ]
  • Gas and Bloating Score [ Time Frame: From enrollment to 14 days post-operatively ]

Central Contacts and Locations

Central contacts

Brooklyn Williams, DO

(253) 968-3105brooklyn.c.williams3.mil@health.mil

Christopher Porta, MD

(253) 968-3105christopher.r.porta.civ@health.mil

Locations

Madigan Army Medical Center

Recruiting

Tacoma, Washington, United States, 98431

Contacts

Christopher Porta, MD

253-968-3105christopher.r.porta.civ@health.mil

More Information

Sponsor

Madigan Army Medical Center

Last update posted

Jun 15, 2025

Last verified

Jan, 2025

Keywords

  • Simethicone
  • Gas-X
  • Foregut
  • Post-operative pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Madigan Army Medical Center on 2025-06-15.