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

W

Wecare Probiotics

Status

Not yet enrolling

Conditions

Sperm Quality

Treatments

Dietary Supplement: Maltodextrin
Dietary Supplement: probiotic product

Study type

Interventional

Funder types

Industry

Identifiers

NCT06544278
WK2023010

Details and patient eligibility

About

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.

Full 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.

Enrollment

46 estimated patients

Sex

Male

Ages

40 to 59 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

46 participants in 2 patient groups, including a placebo group

Probiotic group
Experimental group
Description:
Participants in the probiotic group received 1 sachet probiotic product per day.
Treatment:
Dietary Supplement: probiotic product
Placebo group
Placebo Comparator group
Description:
Participants in the placebo group received 3g of maltodextrin per day.
Treatment:
Dietary Supplement: Maltodextrin

Trial contacts and locations

1

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Central trial contact

Lixiang Li

Data sourced from clinicaltrials.gov

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