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

Not Applicable

Not yet recruiting

• Conditions: Sperm Quality
• Interventions: Dietary Supplement: probiotic product; Dietary Supplement: Maltodextrin

• Registration Number: NCT06544278
• Lead Sponsor: Wecare Probiotics Co., Ltd.

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 Timeline

• Study First Submitted: 2024-07-25
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-05
• Last Update Submitted: 2024-08-05
• Study First Posted: 2024-08-09
• Last Update Posted: 2024-08-09
• Study Start: 2024-08-30
• Primary Completion: 2025-05-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 46

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic group	probiotic product	Participants in the probiotic group received 1 sachet probiotic product per day.
Placebo group	Maltodextrin	Participants in the placebo group received 3g of maltodextrin per day.

Primary Outcome Measures

Name	Time	Method
Change in Sperm Motility Percentage Assessed by Computer-Assisted Sperm Analysis System (CASA) After 8 Weeks	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.

Trial Locations

Locations (1)

Qilu Hospital of Shangdong University; 🇨🇳 Jinan, Shangdong, China