Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06544278
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
The Impact of Probiotics on Sperm Quality in Middle-aged Men
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Effects of Probiotics on Sperm Quality in Middle-aged Men a Randomized Double-blind Placebo-controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None