The Impact of Probiotics on Sperm Quality in Middle-aged Men

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.

Inclusion Criteria: 1. Subjects aged 40-59 years old. 2. Normal levels of gonadotropins, testosterone, and serum prolactin. 3. No use of other traditional Chinese and Western medicines for oligoasthenoteratozoospermia treatment in the past 3 months. 4. Patients who can understand the clinical study and commit to complying with the study requirements and procedures. 5. Patients who have signed the informed consent form and are able to complete the study as per the trial protocol. Exclusion Criteria: 1. Organic lesions of the reproductive system; 2. Use of antibiotics in the two weeks prior to recruitment; 3. Sexual dysfunctions such as erectile dysfunction, ejaculatory abnormalities, preventing completion of sexual intercourse; 4. Genitourinary infections, such as Chlamydia or Mycoplasma infections; 5. Abnormal sex hormone levels; 6. Obesity (BMI greater than 28); 7. History of allergies to the probiotic preparations used in this study; 8. Severe cardiovascular or cerebrovascular diseases, liver or kidney dysfunction, hematologic disorders, psychiatric illnesses, or other severe comorbidities; 9. Use of medications in the past 3 months that may affect the trial; 10. According to the investigator's judgment, the subject's condition does not qualify them for participation in the study.