Qilu Hospital of Shangdong University
Jinan, Shangdong, 250012, China
NCT Number: NCT06544278
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.
Trial opening soon.
Get Notified40 year–59 year
Male
Interventional
Not applicable
Jinan, Shangdong, 250012, China
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Wecare Probiotics Co., Ltd.
Industry
Evaluation of the Effects of Probiotics on Sperm Quality in Middle-aged Men: a Randomized, Double-blind, Placebo-controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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