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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
46
During the experiment, subjects take one sachet probiotic product daily. Evaluation is conducted by monitoring the subjects' semen concentration before and after this trial.
During the experiment, subjects take one sachet maltodextrin daily with 3.0g. Evaluation is conducted by monitoring the subjects' semen concentration before and after this trial.
Qilu Hospital of Shangdong University
Jinan, Shangdong, China
Change in Sperm Motility Percentage Assessed by Computer-Assisted Sperm Analysis System (CASA) After 8 Weeks
The percentage change in sperm motility will be measured using a Computer-Assisted Sperm Analysis System (CASA). Sperm samples will be collected at baseline and after the 8-week intervention. Results will be presented as mean ± standard deviation. The data will be used to assess the effect of Bifidobacterium longum subsp. longum BL21 on sperm motility in middle-aged men.
Time frame: 8 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.