260 Participants Needed

Simethicone for Post-Gastric Bypass Surgery

CP
BW
Overseen ByBrooklyn Williams, DO
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Madigan Army Medical Center
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for patients undergoing foregut procedures, including bariatric surgeries like sleeve gastrectomy and Roux-en-Y gastric bypass, as well as hiatal hernia and other gastric surgeries. It aims to see if simethicone can help with gas pain and bloating after surgery.

Inclusion Criteria

I have had surgery on the upper part of my digestive system.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgical procedures and receive either simethicone or placebo for 14 days postoperatively

2 weeks
Inpatient stay followed by discharge with medication

Follow-up

Participants are monitored for safety and effectiveness after treatment, including completion of surveys at follow-up visit

2 weeks
1 follow-up visit (in-person)

Data Collection and Analysis

Data is collected, de-identified, and analyzed for reporting

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Simethicone
Trial Overview The study tests the safety and effectiveness of simethicone (Gas Relief or Gas-X) in reducing postoperative gas-related discomfort. Participants will either receive Simethicone 80 MG or a placebo to compare outcomes.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental ArmExperimental Treatment1 Intervention
This arm will receive simethicone
Group II: Control ArmPlacebo Group1 Intervention
This arm will receive the placebo pill

Find a Clinic Near You

Who Is Running the Clinical Trial?

Madigan Army Medical Center

Lead Sponsor

Trials
52
Recruited
17,600+
Unbiased ResultsWe believe in providing patients with all the options.
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