Impact of Probiotics on Gut Microbiome During Antibiotic Prophylaxis in Elective Orthopedic Surgery

Starting soon · Phase 4 · Has a placebo group

Conditions studied: Dysbiosis, Gut -microbiota, Microbiome Analysis, Probiotic, Antibiotic Prophylaxis

In brief

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.

Key facts

Study ID

NCT06791993

Run by

Acibadem Maslak Hospital

People needed

60

Starts

2025-02-01

Expected to finish

2025-10-01

Last updated by the study team

2025-01-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults aged between 18 and 65 years
• Scheduled for elective low-risk orthopedic surgery (carpal tunnel release, A1 pulley release, knee arthroscopic surgery).

You may not qualify if…

• 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.

Where it is running

• Parvizi Surgical Innovation — Philadelphia, Pennsylvania, United States
• Thonburi Trang Hastanesi — Thailand, Thailand
• Istanbul University Cerrahpasa — Istanbul, Turkey (Türkiye)
• Acıbadem International Joint Center — Istanbul, Turkey (Türkiye)
• Acibadem LABMED Laboratories — Istanbul, Turkey (Türkiye)
• Acıbadem Mehmet Ali Aydınlar University — Istanbul, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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