HealthyNCT04577625
Effect of Probiotics on Testosterone in Men
A study testing Lactobacillus reuteri (L. reuteri) in people with Healthy, run by BioGaia AB at 1 site in Sweden.
Trial summary
This study evaluates the effect of L. reuteri ATCC PTA 6475 supplementation on testosterone in men. Read more about this study
- Who is it for?
- Ages 50 to 65 years, men only
- Conditions the study is for
- Healthy
- What is being tested?
- Lactobacillus reuteri (L. reuteri)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 5 Nov 2020to 5 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Health & Society, Malmö University
Malmö, Skåne County, 205 06
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Lactobacillus reuteri (L. reuteri)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus reuteri (L. reuteri)Dietary supplement
L.reuteri high or low dose with vitamin D3 compared to vitamin D3 only
| Study group | Role | What they receive |
|---|---|---|
| L. reuteri Low Dose | Active comparator | L. reuteri will be delivered in a capsule at a low dose including Vitamin D3. Administration twice daily. Receives: Dietary Supplement: Lactobacillus reuteri (L. reuteri) |
| L. reuteri High Dose | Active comparator | L. reuteri will be delivered in a capsule at a high dose including Vitamin D3. Administration twice daily. Receives: Dietary Supplement: Lactobacillus reuteri (L. reuteri) |
| Placebo | Placebo comparator | 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. Receives: Dietary Supplement: Lactobacillus reuteri (L. reuteri) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of total testosterone
Change in total testosterone concentration over time
Measured: Baseline, 6 weeks, 12 weeks
Secondary outcomes (3)
Free testosterone index
Change in Free testosterone index (100x(Testosterone/SHBG) over time
Measured: Baseline, 6 weeks, 12 weeks
Percentage of hematokrit
Change in Hematokrit over time
Measured: Baseline, 6 weeks, 12 weeks
Number of adverse events
Adverse event from administration of first dose until 12 weeks
Measured: Continously 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start5 Nov 2020
- Primary completion5 Jun 2021
- Study completion5 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioGaia AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04577625
- Sponsor's protocol ID
- CSUB0176
- Status last verified
- Sep 2020
- First submitted
- 30 Sep 2020
- Last updated
- 21 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Randomized Clinical Study Investigating Lactobacillus Reuteri Supplementations Influence on Testosterone Levels in Healthy Men
- ClinicalTrials.gov ID
- NCT04577625
- Acronym / sponsor ID
- CSUB0176
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- BioGaia ABIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2020 (actual)
- Primary completion
- 5 Jun 2021 (actual)
- Study completion
- 5 Jun 2021 (actual)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| L. reuteri Low Dose | Active comparator | Dietary Supplement: Lactobacillus reuteri (L. reuteri)L. reuteri will be delivered in a capsule at a low dose including Vitamin D3. Administration twice daily. |
| L. reuteri High Dose | Active comparator | Dietary Supplement: Lactobacillus reuteri (L. reuteri)L. reuteri will be delivered in a capsule at a high dose including Vitamin D3. Administration twice daily. |
| Placebo | Placebo comparator | Dietary Supplement: 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. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus reuteri (L. reuteri)L.reuteri high or low dose with vitamin D3 compared to vitamin D3 only | Dietary supplement | L. reuteri High Dose, L. reuteri Low Dose, Placebo |
Primary outcome
Concentration of total testosterone
Time frame: Baseline, 6 weeks, 12 weeks
Change in total testosterone concentration over time
3 secondary outcomes
Free testosterone index
Time frame: Baseline, 6 weeks, 12 weeks
Percentage of hematokrit
Time frame: Baseline, 6 weeks, 12 weeks
Number of adverse events
Time frame: Continously 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus reuteri (L. reuteri) in people with Healthy, run by BioGaia AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of total testosterone (time frame: Baseline, 6 weeks, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2021.