HealthyNCT03160066
The Effects of Lactobacillus Rhamnosus (JB-1) on Stress and Cognition
A study testing Lactobacillus Rhamnosus (JB-1) in people with Healthy, run by University College Cork at 1 site in Ireland.
Trial summary
Emerging evidence suggests that microorganisms acting via the Brain-Gut axis may have potential benefits for the management of stress-related conditions. The majority of studies have focused on animal models. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lactobacillus Rhamnosus (JB-1)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteIreland
- Study dates
- Jul 2015to Sep 2016
- 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 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- able to give informed written consent
- able to speak English
Who cannot join
- having a significant acute or chronic illness
- following a diet or taking a medication that would interfere with study objectives
- pose a safety risk or confound the interpretation of the study results
- evidence of immunodeficiency, bleeding disorder or coagulopathy
- English not being participant's first language
- colour blindness
Show all 9Show fewer
- dyslexia or dyscalculia
- taking any probiotic products or antibiotics in the last 4 weeks
- receiving any treatment involving experimental drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Lactobacillus Rhamnosus (JB-1) on Stress and Cognition in Healthy Volunteers
Emerging evidence suggests that microorganisms acting via the Brain-Gut axis may have potential benefits for the management of stress-related conditions. The majority of studies have focused on animal models. Preclinical studies have identified the Lactobacillus Rhamnosus JB-1 strain as a putative psychobiotic with an impact on stress-related behaviours, physiology and cognitive performance. Whether such preclinical effects could be translated to healthy human volunteers remains unknown.
Read the detailed description
30 healthy male volunteers will be recruited in a randomized single blind placebo controlled cross over trial. Study participation will involve a screening visit followed by a baseline cognitive test battery, EEG and stress visit (socially evaluated cold-pressor test). These measures will be repeated after 4 weeks of daily probiotic and placebo capsules.
- Conditions
- Healthy
- Being tested
- Lactobacillus Rhamnosus (JB-1), Placebo
- Keywords
- Psychobiotic, Brain-gut axis, Stress, Cognition, EEG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus Rhamnosus (JB-1)Dietary supplement
Lactobacillus Rhamnosus (JB-1) capsule
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Capsules containing 1x10^9 colony forming units of Lactobacillus Rhamnosus (JB-1) will be given once per day for 4 weeks. Receives: Dietary Supplement: Lactobacillus Rhamnosus (JB-1) |
| Placebo | Placebo comparator | Placebo capsules identical to the probiotic in taste, smell, colour, and comprised only of the same non-active ingredients (corn starch, magnesium stearate and silicon dioxide) in the probiotic supplement will be given once per day for 4 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cognition
A battery of cognitive tests will be assessed using the Cambridge Neuropsychological Test Automated Battery
Measured: Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment
Secondary outcomes (6)
Change in the Inflammatory profile
Cytokine levels and toll-like receptor activity
Measured: Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment
Changes in Mood
Beck Depression Inventory
Measured: Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment
Change in Electroencephalography (EEG)
EEG measures of absolute power in the delta (1.5-3.5Hz), theta (4-7.5Hz), alpha1 (8- 9.5Hz), alpha2 (10-12.5Hz), beta1 (13-17.5Hz), and beta2 (18-25.5Hz) frequency bands
Measured: Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment
Change in Salivary cortisol concentrations
Salivary cortisol will be collected before and after the socially evaluated cold pressor procedure.
Measured: Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment
Changes in Anxiety
Beck Anxiety Inventory
Measured: Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment
Changes in Stress levels
Perceived Stress Scale
Measured: Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study startJul 2015
- Primary completionSep 2016
- Study completionSep 2016
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Ted Dinan, University College Cork
- Investigators
- Ted Dinan, MD, PhD, Principal investigator, University College Cork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03160066
- Sponsor's protocol ID
- APC057
- Status last verified
- May 2017
- First submitted
- 17 Dec 2015
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Lactobacillus Rhamnosus (JB-1) on Stress and Cognition in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03160066
- Acronym / sponsor ID
- APC057
- Conditions
- Healthy
- Keywords
- Psychobiotic, Brain-gut axis, Stress, Cognition, EEG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 19 May 2017 (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.
Emerging evidence suggests that microorganisms acting via the Brain-Gut axis may have potential benefits for the management of stress-related conditions. The majority of studies have focused on animal models. Preclinical studies have identified the Lactobacillus Rhamnosus JB-1 strain as a putative psychobiotic with an impact on stress-related behaviours, physiology and cognitive performance. Whether such preclinical effects could be translated to healthy human volunteers remains unknown.
Detailed description
30 healthy male volunteers will be recruited in a randomized single blind placebo controlled cross over trial. Study participation will involve a screening visit followed by a baseline cognitive test battery, EEG and stress visit (socially evaluated cold-pressor test). These measures will be repeated after 4 weeks of daily probiotic and placebo capsules.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Dietary Supplement: Lactobacillus Rhamnosus (JB-1)Capsules containing 1x10^9 colony forming units of Lactobacillus Rhamnosus (JB-1) will be given once per day for 4 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo capsules identical to the probiotic in taste, smell, colour, and comprised only of the same non-active ingredients (corn starch, magnesium stearate and silicon dioxide) in the probiotic supplement will be given once per day for 4 weeks. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- able to give informed written consent
- able to speak English
Key exclusion criteria (9 listed)
- having a significant acute or chronic illness
- following a diet or taking a medication that would interfere with study objectives
- pose a safety risk or confound the interpretation of the study results
- evidence of immunodeficiency, bleeding disorder or coagulopathy
- English not being participant's first language
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 Rhamnosus (JB-1)Lactobacillus Rhamnosus (JB-1) capsule | Dietary supplement | Active |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
Change in Cognition
Time frame: Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment
A battery of cognitive tests will be assessed using the Cambridge Neuropsychological Test Automated Battery
6 secondary outcomes
Change in the Inflammatory profile
Time frame: Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment
Changes in Mood
Time frame: Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment
Change in Electroencephalography (EEG)
Time frame: Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment
Change in Salivary cortisol concentrations
Time frame: Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment
Changes in Anxiety
Time frame: Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment
Changes in Stress levels
Time frame: Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment
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 30 May 2017.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Ted Dinan, MD, PhD principal investigator
University College Cork
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 Rhamnosus (JB-1) in people with Healthy, run by University College Cork at 1 site in Ireland.
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 2 inclusion and 9 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 30 May 2017. 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 Ireland. 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?
Change in Cognition (time frame: Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment). 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 30 May 2017; AzTrials last refreshed its copy on 8 Nov 2026.