Effect of Probiotics on Testosterone in Men

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Lactobacillus reuteri (L. reuteri)

• Registration Number: NCT04577625
• Lead Sponsor: BioGaia AB

Brief Summary

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

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 Timeline

• Status Verified: 2020-09
• Study First Submitted: 2020-09-30
• Study First Submitted QC: 2020-09-30
• Study First Posted: 2020-10-08
• Study Start: 2020-11-05
• Primary Completion: 2021-06-05
• Study Completion: 2021-06-05
• Last Update Submitted: 2021-06-18
• Last Update Posted: 2021-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
L. reuteri Low Dose	Lactobacillus reuteri (L. reuteri)	L. reuteri will be delivered in a capsule at a low dose including Vitamin D3. Administration twice daily.
Placebo	Lactobacillus reuteri (L. reuteri)	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.
L. reuteri High Dose	Lactobacillus reuteri (L. reuteri)	L. reuteri will be delivered in a capsule at a high dose including Vitamin D3. Administration twice daily.

Primary Outcome Measures

Name	Time	Method
Concentration of total testosterone	Baseline, 6 weeks, 12 weeks	Change in total testosterone concentration over time

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Health & Society, Malmö University; 🇸🇪 Malmö, Skåne, Sweden