Impact of Probiotics on Gut Microbiome During Antibiotic Prophylaxis in Elective Orthopedic Surgery (NCT06791993)
๐ฉบ Plain-English Summary (8th-Grade Level)
This study aims to evaluate whether probiotics can help maintain a healthy gut microbiome in patients receiving prophylactic antibiotics during elective orthopedic surgery. Antibiotics, while effective in preventing infections, can disrupt the balance of gut bacteria, leading to dysbiosis. The study hypothesizes that the use of probiotics during the perioperative period can prevent or reduce this disruption, supporting gut health and overall well-being. The research seeks to answer whether combining probiotics with routine antibiotic prophylaxis can preserve gut microbiome balance and improve patient outcomes.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (2 items) and avoid the listed exclusions (7 items).
Location: Parvizi Surgical Innovation โ Philadelphia, Pennsylvania
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- History of infection or antibiotic use within the last 12 weeks.
- Use of routine probiotics, vitamins, or herbal supplements in the last 4 weeks.
- Known allergy to beta-lactam or cephalosporin antibiotics.
- History of autoimmune disease, uncontrolled systemic disease, or chronic inflammatory conditions (e.g., systemic lupus erythematosus, rheumatoid arthritis).
- History of chronic intestinal diseases such as small intestine bacterial overgrowth (SIBO), irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), or celiac disease.
- Increased risk of infection due to medical comorbidities or use of immunosuppressive drugs.
๐ Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
๐ All Participating Trial Locations (6 Sites)
- Parvizi Surgical Innovation โ Philadelphia, Pennsylvania
- Thonburi Trang Hastanesi โ Thailand,
- Istanbul University Cerrahpasa โ Istanbul,
- Acฤฑbadem International Joint Center โ Istanbul,
- Acibadem LABMED Laboratories โ Istanbul,
- Acฤฑbadem Mehmet Ali Aydฤฑnlar University โ Istanbul,
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.