Impact of Probiotics Combined with Antibiotic Prophylaxis on Gut Microbiome Balance in Patients Undergoing Elective Orthopedic Surgery, Double-Blinded Randomized Controlled Trial
Acibadem Maslak Hospital
Summary
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.
Description
This double-blinded, randomized controlled trial aims to evaluate the effect of probiotics on maintaining gut microbiome balance in patients undergoing elective orthopedic surgery who receive routine prophylactic antibiotics. Antibiotics, while essential for reducing the risk of surgical site infections, are known to disrupt gut microbiota, leading to dysbiosis, an imbalance in microbial composition. Dysbiosis can compromise gut health, reduce microbial diversity, and impair metabolic functions essential for recovery. The study explores whether a dual-strain probiotic with Human Milk Oligosac…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Adults aged between 18 and 65 years * Scheduled for elective low-risk orthopedic surgery (carpal tunnel release, A1 pulley release, knee arthroscopic surgery). 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 intes…
Interventions
- DrugPlacebo Capsule
Participants will receive an inert placebo capsule that matches the probiotic capsule in size, shape, and color. The placebo will be administered orally twice daily, starting 2 weeks before surgery and continuing for 2 weeks postoperatively.
- Dietary SupplementProbiotic with Human Milk Oligosaccharides (HMO)
Participants will receive a dual-strain probiotic containing Human Milk Oligosaccharides (HMO) in capsule form. The probiotic will be administered orally twice daily, starting 2 weeks before surgery and continuing for 2 weeks postoperatively.
Locations (6)
- Parvizi Surgical InnovationPhiladelphia, Pennsylvania
- Thonburi Trang HastanesiThailand
- Istanbul University CerrahpasaIstanbul
- Acıbadem International Joint CenterIstanbul
- Acibadem LABMED LaboratoriesIstanbul
- Acıbadem Mehmet Ali Aydınlar UniversityIstanbul