Effect of Probiotics on Testosterone in Men

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Lactobacillus reuteri (L. reuteri)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Skåne
    • Malmö, Skåne, Sweden, 205 06
      • Department of Health & Society, Malmö University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: L. reuteri Low Dose; L. reuteri will be delivered in a capsule at a low dose including Vitamin D3. Administration twice daily.	Dietary supplement: Lactobacillus reuteri (L. reuteri); L.reuteri high or low dose with vitamin D3 compared to vitamin D3 only
Active Comparator: L. reuteri High Dose; L. reuteri will be delivered in a capsule at a high dose including Vitamin D3. Administration twice daily.	Dietary supplement: Lactobacillus reuteri (L. reuteri); L.reuteri high or low dose with vitamin D3 compared to vitamin D3 only
Placebo Comparator: Placebo; The placebo product will be identical to the active product in taste and appearance and include Vitamin D3 but without the L. reuteri. Administration twice daily.	Dietary supplement: Lactobacillus reuteri (L. reuteri); L.reuteri high or low dose with vitamin D3 compared to vitamin D3 only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of total testosterone	Change in total testosterone concentration over time	Baseline, 6 weeks, 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Free testosterone index	Change in Free testosterone index (100x(Testosterone/SHBG) over time	Baseline, 6 weeks, 12 weeks
Percentage of hematokrit	Change in Hematokrit over time	Baseline, 6 weeks, 12 weeks
Number of adverse events	Adverse event from administration of first dose until 12 weeks	Continously 12 weeks

Collaborators and Investigators

• Sponsor: BioGaia AB

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2020
• Primary Completion (Actual): June 5, 2021
• Study Completion (Actual): June 5, 2021

Study Registration Dates

• First Submitted: September 30, 2020
• First Submitted That Met QC Criteria: September 30, 2020
• First Posted (Actual): October 8, 2020

Study Record Updates

• Last Update Posted (Actual): June 21, 2021
• Last Update Submitted That Met QC Criteria: June 18, 2021
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CSUB0176

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No