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NOT YET RECRUITING
NCT06791993
PHASE4

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

Sponsor: Acibadem Maslak Hospital

View on ClinicalTrials.gov

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.

Official title: Impact of Probiotics Combined with Antibiotic Prophylaxis on Gut Microbiome Balance in Patients Undergoing Elective Orthopedic Surgery, Double-Blinded Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-02-01

Completion Date

2025-10-01

Last Updated

2025-01-24

Healthy Volunteers

No

Interventions

DRUG

Placebo 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_SUPPLEMENT

Probiotic 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 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)