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OpenTrials
Completed

NCT Number: NCT04577625

Effect of Probiotics on Testosterone in Men

This study evaluates the effect of L. reuteri ATCC PTA 6475 supplementation on testosterone in men.

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Key information

Conditions

Age range

50 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Health & Society, Malmö University

Malmö, Skåne County, 205 06, Sweden

About this study

The probiotic Lactobacillus reuteri ATCC PTA 6475 has been shown to modulate testosterone levels in mice. It is not known if these effects are seen in humans and this trial is intended to study this.

The aim of this study is to investigate if L. reuteri ATCC PTA 6475 will effect blood testosterone levels in in healthy male subjects 50-65 years of age.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Willing and able to give signed informed consent for participation in the study.
  • Healthy males aged between 50-65 with no known underlying medical conditions
  • Subjects who are capable of taking themselves to testing centre at 3 separate timepoints (Baseline, week 6 and week 12).
  • Subjects who are available to give fasting blood samples before 10am on day of blood sample collection
  • No history of androgen or testosterone supplementation within 6 months prior to study start.
  • Subjects who have not been taking antibiotics or probiotic supplements 4 weeks prior to study start 8. Able and willing to comply with the restirictions defined for the study period
  • Ability to understand and comply with the requirements of the study, as judged by the investigator physician

Exclusion criteria

  • Subjects who presently have or have had cardiovascular issues in the past 2 years.
  • Subjects who have a Body Mass Index of < 18 or > 30
  • Known elevated Prostate Specific Antigen levels.
  • History of prostate or testicular cancer.
  • Nicotine abuse
  • Alcohol abuse

Treatment and study plan

Lactobacillus reuteri (L. reuteri)

Dietary Supplement

L.reuteri high or low dose with vitamin D3 compared to vitamin D3 only

Primary outcomes

  1. Concentration of total testosterone

    Time frame: Baseline, 6 weeks, 12 weeks

    Change in total testosterone concentration over time

Secondary outcomes

  1. Free testosterone index

    Time frame: Baseline, 6 weeks, 12 weeks

    Change in Free testosterone index (100x(Testosterone/SHBG) over time

  2. Percentage of hematokrit

    Time frame: Baseline, 6 weeks, 12 weeks

    Change in Hematokrit over time

  3. Number of adverse events

    Time frame: Continously 12 weeks

    Adverse event from administration of first dose until 12 weeks

Sponsors and collaborators

Lead sponsor

BioGaia AB

Industry

Registry information

Official study title

A Double-blind Randomized Clinical Study Investigating Lactobacillus Reuteri Supplementations Influence on Testosterone Levels in Healthy Men

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 8, 2020
Registry last updated
Jun 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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