The Impact of Probiotics on Sperm Quality in Middle-aged Men
ConditionSperm Quality
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age40-59
SponsorWecare Probiotics Co., Ltd.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
probiotic product
Dietary supplementDuring the experiment, subjects take one sachet probiotic product daily. Evaluation is conducted by monitoring the subjects' semen concentration before and after this trial.
Maltodextrin
Dietary supplementDuring 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.
Treatment groups
46 Participants
are divided into 2 treatment groupsGroup A: Probiotic groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: