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

ConditionsDysbiosis Gut -microbiota Microbiome Analysis Probiotic Antibiotic Prophylaxis

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18-65

SponsorAcibadem Maslak Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged between 18 and 65 years

Scheduled for elective low-risk orthopedic surgery (carpal tunnel release, A1 pulley release, knee arthroscopic surgery).

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

Placebo Capsule
Drug
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.
Probiotic with Human Milk Oligosaccharides (HMO)
Dietary supplement
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.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Routine Antibiotic Prophylaxis + PlaceboPlacebo comparator 1 intervention

Group B: Routine Antibiotic Prophylaxis + ProbioticsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Maintenance of Gut Microbiome Balance

Evaluate whether probiotic administration preserves gut microbiome balance during the perioperative period by assessing changes in microbial richness, diversity, and evenness. Shotgun metagenomic sequencing analysis will be used to measure microbial composition and diversity.

Time frame