Impact of Probiotics Combined with Antibiotic Prophylaxis on Gut Microbiome Balance in Patients Undergoing Elective Orthopedic Surgery, Double-Blinded Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Maintenance of Gut Microbiome Balance
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
In addition to participants, care providers, investigators, and outcomes assessors, the study's pharmacy personnel responsible for dispensing the intervention are also masked to the group assignments. Placebo and probiotic capsules are prepared to be identical in appearance and packaging, ensuring that no party involved in the trial can distinguish between the two interventions. Randomization and allocation are managed by an independent third party to maintain blinding integrity throughout the study.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged between 18 and 65 years
- •Scheduled for elective low-risk orthopedic surgery (carpal tunnel release, A1 pulley release, knee arthroscopic surgery).
排除标准
- •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.
研究组 & 干预措施
Routine Antibiotic Prophylaxis + Placebo
This arm receives routine antibiotic prophylaxis with a single dose of intravenous Cefazolin and a placebo capsule to match the probiotic intervention.
干预措施: Placebo Capsule (Drug)
Routine Antibiotic Prophylaxis + Probiotics
This arm receives routine antibiotic prophylaxis with a single dose of intravenous Cefazolin and a dual-strain probiotic containing Human Milk Oligosaccharides (HMO).
干预措施: Probiotic with Human Milk Oligosaccharides (HMO) (Dietary Supplement)
结局指标
主要结局
Maintenance of Gut Microbiome Balance
时间窗: 2 weeks preoperatively (T0) to 1 month postoperatively (T4).
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.
次要结局
- Firmicutes/Bacteroidetes Ratio(2 weeks preoperatively (T0) to 1 month postoperatively (T4).)
- Short-Chain Fatty Acid (SCFA) Production(2 weeks preoperatively (T0) to 1 month postoperatively (T4).)
- Dysbiosis Index(2 weeks preoperatively (T0) to 1 month postoperatively (T4).)
- Microbiome health index ( MHI) OR Microbiome health index for post-antiobiotic (MHI- A)(2 weeks preoperatively (T0) to 1 month postoperatively (T4).)
- WHO-5 Well-being Index(1 week preoperatively (T1) and 2 weeks postoperatively (T3).)
- EuroQol 5-Dimension (EQ-5D) score.(1 week preoperatively (T1) and 2 weeks postoperatively (T3).)