Evaluation of the Effects of Probiotics on Sperm Quality in Middle-aged Men: a Randomized, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Progressive Sperm Motility Assessed by Computer-Assisted Sperm Analysis
研究概览
简要总结
The clinical trial aims to investigate the impact of probiotic strain BL21 on sperm quality among 46 middle-aged male participants. The primary objective is to validate whether probiotic strain BL21 can effectively improve sperm quality among middle-aged male participants. Initially, participants were instructed to consume the recommended amount of probiotic powder for approximately 8 weeks. At baseline, week 4, and week 8 endpoints, semen analysis, hormone level testing, serum cytokine testing were conducted on the participants, and stool samples were collected from them.
详细描述
Research has indicated that an increase in male age is independently associated with a reduction in the percentage of motile sperm and sperm with normal morphology, especially in men over 40 years old, potentially linking to a decline in fertility rates. Preclinical studies have shown that supplementation with Long Bifidobacterium can regulate immune responses, inhibit tissue inflammatory factors, and the predictive functions of the gut microbiota suggest an increase in gene abundance within pathways related to secondary metabolite production, antibiotic synthesis, and amino acid biosynthesis in the gut microbiota. To ascertain the effectiveness of the Bifidobacterium BL21 product, a consumer testing experiment was conducted by the investigators to evaluate and gather data on alterations in the gut microbiota of participants prior to and following the use of the product. The trial spanned over 8 weeks, with washout periods incorporated at the commencement and conclusion. Throughout the study, participants ingested Bifidobacterium BL21 and were subjected to a series of health examinations and assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double(Participant,Investigator)
入排标准
- 年龄范围
- 40 Years 至 59 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subjects aged 40-59 years old.
- •Normal levels of gonadotropins, testosterone, and serum prolactin.
- •No use of other traditional Chinese and Western medicines for oligoasthenoteratozoospermia treatment in the past 3 months.
- •Patients who can understand the clinical study and commit to complying with the study requirements and procedures.
- •Patients who have signed the informed consent form and are able to complete the study as per the trial protocol.
排除标准
- •Organic lesions of the reproductive system;
- •Use of antibiotics in the two weeks prior to recruitment;
- •Sexual dysfunctions such as erectile dysfunction, ejaculatory abnormalities, preventing completion of sexual intercourse;
- •Genitourinary infections, such as Chlamydia or Mycoplasma infections;
- •Abnormal sex hormone levels;
- •Obesity (BMI greater than 28);
- •History of allergies to the probiotic preparations used in this study;
- •Severe cardiovascular or cerebrovascular diseases, liver or kidney dysfunction, hematologic disorders, psychiatric illnesses, or other severe comorbidities;
- •Use of medications in the past 3 months that may affect the trial;
- •According to the investigator's judgment, the subject's condition does not qualify them for participation in the study.
研究组 & 干预措施
Probiotic group
Participants in the probiotic group received 1 sachet probiotic product per day.
干预措施: probiotic product (Dietary Supplement)
Placebo group
Participants in the placebo group received 3g of maltodextrin per day.
干预措施: Maltodextrin (Dietary Supplement)
结局指标
主要结局
Progressive Sperm Motility Assessed by Computer-Assisted Sperm Analysis
时间窗: Baseline and week 8
Progressive sperm motility will be assessed using a computer-assisted sperm analysis system (CASA) at baseline and week 8.
次要结局
未报告次要终点