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

Evaluation of the Effects of Probiotics on Sperm Quality in Middle-aged Men: a Randomized, Double-blind, Placebo-controlled 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sperm Quality
• Intervention / Treatment: Dietary supplement: probiotic product; Dietary supplement: Maltodextrin

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 Type: Interventional
• Enrollment (Estimated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lixiang Li; Phone Number: 18560082215; Email: lilixiang@sdu.edu.cn

Study Locations

• China
  • Shangdong
    • Jinan, Shangdong, China, 250012
      • Qilu Hospital of Shangdong University
      • Contact: Lixiang Li, Dr.; Phone Number: 18560082215; Email: lilixiang@sdu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group; Participants in the placebo group received 3g of maltodextrin per day.	Dietary supplement: Maltodextrin; 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.
Experimental: Probiotic group; Participants in the probiotic group received 1 sachet probiotic product per day.	Dietary supplement: probiotic product; During the experiment, subjects take one sachet probiotic product daily. Evaluation is conducted by monitoring the subjects' semen concentration before and after this trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 weeks

Collaborators and Investigators

• Sponsor: Wecare Probiotics Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): August 30, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: July 25, 2024
• First Submitted That Met QC Criteria: August 5, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 5, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: WK2023010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No