Simethicone for Post-Gastric Bypass Surgery
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial focuses on determining whether simethicone, a common gas relief medication, can reduce gas pain and bloating after stomach surgeries like gastric bypass or hiatal hernia surgery. Participants will receive either simethicone or a placebo (a pill with no active drug) to assess any difference in symptom relief. Individuals who have undergone foregut procedures, such as bariatric surgeries, and experience gas-related discomfort may be suitable candidates for this trial. As a Phase 4 trial, the research aims to explore how this FDA-approved and effective treatment can benefit more patients.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What is the safety track record for simethicone?
Research has shown that simethicone, also known as Gas Relief or Gas-X, is safe for use. It does not get absorbed into the body, making it safe during pregnancy and breastfeeding. This is reassuring, as simethicone is unlikely to cause harmful effects internally.
The FDA has approved simethicone to relieve symptoms such as gas pressure and bloating. Although no specific treatment exists for simethicone overdose, this is rarely a concern due to its safety. Overall, simethicone is well-tolerated and commonly used to ease digestive discomfort.12345Why are researchers enthusiastic about this study treatment?
Simethicone is unique because it targets gas-related discomfort specifically after gastric bypass surgery. Unlike other treatments that may address multiple digestive issues, simethicone is an anti-foaming agent that directly reduces gas bubbles in the stomach and intestines. This targeted action could provide quicker relief from bloating and discomfort compared to the broader options like dietary adjustments or other medications that don't specifically focus on gas reduction. Researchers are excited about simethicone's potential to improve post-surgical recovery by making patients more comfortable without the need for more complex interventions.
What evidence suggests that simethicone is effective for post-gastric bypass surgery?
Research has shown that simethicone, also known as Gas Relief or Gas-X, effectively reduces discomfort from gas. It breaks up gas bubbles in the stomach and intestines, relieving pressure, bloating, and a feeling of fullness. The FDA has already approved this treatment for these symptoms. Studies have demonstrated that simethicone can significantly ease gas pain and bloating, making it a reliable choice for those experiencing these issues after stomach surgeries. Extensive clinical experience supports its effectiveness. Participants in this trial will receive either simethicone or a placebo to evaluate its effectiveness specifically for post-gastric bypass surgery.13678
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo surgical procedures and receive either simethicone or placebo for 14 days postoperatively
Follow-up
Participants are monitored for safety and effectiveness after treatment, including completion of surveys at follow-up visit
Data Collection and Analysis
Data is collected, de-identified, and analyzed for reporting
What Are the Treatments Tested in This Trial?
Interventions
- Simethicone
Find a Clinic Near You
Who Is Running the Clinical Trial?
Madigan Army Medical Center
Lead Sponsor