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

NCT06544278 | Completed

• 1 other identifier: WK2023010
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Semen Quality

Keywords

Sperm Quality

Outcome Measures

Primary Outcomes (1)

• Progressive Sperm Motility Assessed by Computer-Assisted Sperm Analysis

  Progressive sperm motility will be assessed using a computer-assisted sperm analysis system (CASA) at baseline and week 8.

  Baseline and week 8

Study Arms (2)

Probiotic group

EXPERIMENTAL

Participants in the probiotic group received 1 sachet probiotic product per day.

Dietary Supplement: probiotic product

Placebo group

PLACEBO COMPARATOR

Participants in the placebo group received 3g of maltodextrin per day.

Dietary Supplement: Maltodextrin

Interventions

probiotic product DIETARY_SUPPLEMENT

During the experiment, subjects take one sachet probiotic product daily. Evaluation is conducted by monitoring the subjects' semen concentration before and after this trial.

Probiotic group

Maltodextrin DIETARY_SUPPLEMENT

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.

Placebo group

Eligibility Criteria

• Age: 40 Years - 59 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Patients who have signed the informed consent form and are able to complete the study as per the trial protocol.

You may not qualify if:

• 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;
• Abnormal sex hormone levels;
• Obesity (BMI greater than 28);
• History of allergies to the probiotic preparations used in this study;
• Severe cardiovascular or cerebrovascular diseases, liver or kidney dysfunction, hematologic disorders, psychiatric illnesses, or other severe comorbidities;
• Use of medications in the past 3 months that may affect the trial;
• According to the investigator's judgment, the subject's condition does not qualify them for participation in the study.

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead

Study Sites (1)

Qilu Hospital of Shangdong University

Jinan, Shangdong, 250012, China

Location

MeSH Terms

Interventions

maltodextrin

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double(Participant,Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: August 9, 2024
• Study Start: August 30, 2024
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: August 7, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)