NCT06544278

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
21 days until next milestone

Study Start

First participant enrolled

August 30, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

8 months

First QC Date

July 25, 2024

Last Update Submit

August 5, 2024

Conditions

Sperm Quality

Outcome Measures

Primary Outcomes (1)

  • 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

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 productDIETARY_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
MaltodextrinDIETARY_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

Age40 Years - 59 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Hospital of Shangdong University

Jinan, Shangdong, 250012, China

Location

MeSH Terms

Interventions

maltodextrin

Central Study Contacts

Lixiang Li

CONTACT

18560082215lilixiang@sdu.edu.cn

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 9, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)