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Search / Trial NCT06791993

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

Launched by ACIBADEM MASLAK HOSPITAL · Jan 18, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Gut Microbiome Intestinal Dysbiosis Surgical Site Infection Probiotics Antibiotic Prophylaxis Human Milk Oligosaccharides (Hmo) Shotgun Metagenomic Sequencing Short Chain Fatty Acids (Scf As)

ClinConnect Summary

This clinical trial is studying whether probiotics, which are good bacteria that help keep our gut healthy, can help maintain a balanced gut microbiome in patients who are taking antibiotics before elective orthopedic surgeries, like knee arthroscopy or carpal tunnel release. Antibiotics are important for preventing infections after surgery, but they can also upset the natural balance of gut bacteria, leading to problems like dysbiosis. The researchers believe that taking probiotics during this time might help protect gut health and improve overall recovery.

To participate in this trial, you would need to be an adult between 18 and 65 years old and scheduled for one of the specified orthopedic surgeries. However, if you have taken antibiotics or certain supplements recently, have a history of specific health issues (like autoimmune diseases or chronic intestinal problems), or have allergies to certain antibiotics, you might not be eligible. If you join the study, you can expect to receive either probiotics or a placebo (an inactive substance) during your treatment period, and the researchers will monitor your gut health and recovery closely. This trial aims to find out if probiotics can make a real difference in keeping your gut healthy while you’re on antibiotics.

Gender

ALL

Eligibility criteria

  • 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 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.

About Acibadem Maslak Hospital

Acibadem Maslak Hospital is a leading healthcare institution located in Istanbul, Turkey, renowned for its commitment to advanced medical care and innovative research. As a prominent sponsor of clinical trials, the hospital integrates cutting-edge technology with a multidisciplinary approach to enhance patient outcomes and drive medical advancements. With a team of highly specialized professionals and state-of-the-art facilities, Acibadem Maslak Hospital is dedicated to conducting rigorous clinical research that adheres to international standards, ensuring the safety and efficacy of new treatments across various therapeutic areas. Through its robust clinical trial programs, the hospital aims to contribute significantly to the global medical community while providing patients with access to the latest therapeutic options.

Locations

Istanbul, , Turkey

Philadelphia, Pennsylvania, United States

Thailand, , Thailand

Istanbul, , Turkey

Istanbul, , Turkey

Istanbul, , Turkey

Patients applied

0 patients applied

Trial Officials

Javad Parvizi, Prof. Dr.

Study Chair

International Joint Center Acibadem, Parvizi Surgical Innovation

Emanuele Chisari, Dr., Ph.D.

Study Director

Parvizi Surgical Innovation, University of Groningen

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported