Clinical trial NCT06791993: Impact of Probiotics on Gut Microbiome During Antibiotic Prophylaxis in Elective Orthopedic Surgery
Official title: Impact of Probiotics Combined with Antibiotic Prophylaxis on Gut Microbiome Balance in Patients Undergoing Elective Orthopedic Surgery, Double-Blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Dysbiosis
Gut -microbiota
Microbiome Analysis
Probiotic
Antibiotic Prophylaxis
Keywords: Gut Microbiome
Intestinal Dysbiosis
Surgical Site Infection
Probiotics
Antibiotic Prophylaxis
Human Milk Oligosaccharides (HMO)
Shotgun Metagenomic Sequencing
Short-Chain Fatty Acids (SCFAs)
Lead sponsor: Acibadem Maslak Hospital
Sponsor class: OTHER
Collaborators: name: Acibadem University
First posted: 2025-01-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study uses a parallel group design where participants are randomly assigned to one of two independent arms. One group receives routine antibiotic prophylaxis with a placebo capsule, while the other group receives routine antibiotic prophylaxis combined with a dual-strain probiotic containing Human Milk Oligosaccharides (HMO). The interventions are administered concurrently over the perioperative period to evaluate their effects on gut microbiome balance and patient recovery. Randomization and blinding ensure unbiased comparisons between the groups.
Primary purpose: PREVENTION

Brief 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.

Detailed 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 Oligosaccharides (HMO) can prevent or minimize dysbiosis during the perioperative period. By comparing patients receiving routine antibiotics alone with those receiving antibiotics plus probiotics, this trial seeks to identify if probiotics can preserve gut microbial diversity and function.

To assess the impact, fecal samples collected at specific time points will undergo detailed microbiome analysis, including metrics such as microbial richness, diversity, and such. Secondary measures will evaluate the broader effects on patient well-being during the recovery period.

This study is designed to provide evidence for the potential role of probiotics as an adjunct therapy to maintain gut health during antibiotic use, offering a novel approach to improving post-surgical recovery and patient outcomes.

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.

Primary outcomes:
measure: Maintenance of Gut Microbiome Balance
timeFrame: 2 weeks preoperatively (T0) to 1 month postoperatively (T4).
Secondary outcomes:
measure: Firmicutes/Bacteroidetes Ratio
timeFrame: 2 weeks preoperatively (T0) to 1 month postoperatively (T4).
measure: Short-Chain Fatty Acid (SCFA) Production
timeFrame: 2 weeks preoperatively (T0) to 1 month postoperatively (T4).
measure: Dysbiosis Index
timeFrame: 2 weeks preoperatively (T0) to 1 month postoperatively (T4).
measure: Microbiome health index ( MHI) OR Microbiome health index for post-antiobiotic (MHI- A)
timeFrame: 2 weeks preoperatively (T0) to 1 month postoperatively (T4).
measure: WHO-5 Well-being Index
timeFrame: 1 week preoperatively (T1) and 2 weeks postoperatively (T3).
measure: EuroQol 5-Dimension (EQ-5D) score.
timeFrame: 1 week preoperatively (T1) and 2 weeks postoperatively (T3).
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Parvizi Surgical Innovation
state: Pennsylvania
city: Thailand
country: Thailand
facility: Thonburi Trang Hastanesi
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa
city: Istanbul
country: Turkey
facility: Acıbadem International Joint Center
city: Istanbul
country: Turkey
facility: Acibadem LABMED Laboratories
city: Istanbul
country: Turkey
facility: Acıbadem Mehmet Ali Aydınlar University
Study officials:
affiliation: International Joint Center Acibadem, Parvizi Surgical Innovation
name: Javad Parvizi, Prof. Dr.
role: STUDY_CHAIR
affiliation: Parvizi Surgical Innovation, University of Groningen
name: Emanuele Chisari, Dr., Ph.D.
role: STUDY_DIRECTOR
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