Probiotic bacteria for work-related stress
| ISRCTN | ISRCTN15033071 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15033071 |
| Secondary identifying numbers | 7582 |
- Submission date
- 28/04/2021
- Registration date
- 29/04/2021
- Last edited
- 12/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Stress in the workplace can occur when employees feel they do not have the support of supervisors and/or colleagues and little control over work processes. This condition can affect the quality of work and life of employees. Worldwide, work-related stress is perceived as a burden. The existence of two-way communication between the brain and the gut, known as the gut-brain axis, has long been recognized. Recent advances have revealed that an imbalance of the gut microbiota (microorganisms) (dysbiosis) is present in many neurological diseases. Consequently, the importance of maintaining a balanced microbial community in the regulation of the gut-brain axis is also of fundamental importance in stress management. Therefore, the aim of this study is to find out whether two probiotic strains, Lactobacillus reuteri PBS072 and Bifidobacterium breve BB077, are effective as dietary supplements in the management of stress and sleep disorders.
Who can participate?
Adult workers aged 18-65
What does the study involve?
Participants are randomly allocated to take one capsule (active or placebo) per day for a period of 30 days, followed by a 4 weeks (30 days) wash-out. At the end of the wash-out period, participants take one capsule again per day for 30 days as the second treatment. Sleep quality and mood are assessed at the start of the study and after 30 days.
What are the possible benefits and risks of participating?
Participants may benefit from the regulation of gut microbiota achieved by the probiotics and eventually a reduction in work-related stress symptoms. No major risks from participating in the study are expected.
Where is the study run from?
University of Calabria (Italy)
When is the study starting and how long is it expected to run for?
December 2020 to August 2021
Who is funding the study?
University of Calabria (Italy)
Who is the main contact?
Prof. Francesco Puoci
francesco.puoci@unical.it
Contact information
Scientific
via P. Bucci
Rende (CS)
87036
Italy
| Phone | +39 (0)984493151 |
|---|---|
| francesco.puoci@unical.it |
Study information
| Study design | Single-center interventional double-blinded randomized controlled cross-over trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | ISRCTN15033071_PIS.pdf |
| Scientific title | Efficacy of Lactobacillus reuteri PBS072 and Bifidobacterium breve BB077 in the prevention and treatment of work-related stress symptoms: a cross-over randomized trial |
| Study acronym | ProWRS |
| Study objectives | Probiotics are able to counteract dysbiosis, which is linked to altered behavioral responses to stress. |
| Ethics approval(s) | Approved 22/03/2021, Comitato Etico di Ateneo, University of Calabria (P. Bucci, 87036, Rende (CS), Italy; +39 (0)984 496940; cea@unical.it), ref: 0007582 |
| Health condition(s) or problem(s) studied | Work-related stress |
| Intervention | A cross-over clinical study will be carried out to evaluate the efficacy of the probiotic formulation composed of 2 × 10(9) CFU Lactobacillus reuteri PBS072 and 2 × 10(9) CFU Bifidobacterium breve BB077 in the prevention and/or treatment of work-related stress symptoms in employees through oral intake. During the study, the volunteers will take one capsule of product, active or placebo (first treatment) per day for a period of 30 days, followed by a 4 weeks (30 days) wash-out. At the end of the wash-out period, each volunteer will take one capsule again per day for 30 days of the second treatment. The two treatments will be randomly assigned. Randomization: central computerized simple randomization Intervention: 30 days Treatment A + 4 weeks (30 days) wash-out + 30 days Treatment B + 15 days follow-up |
| Intervention type | Supplement |
| Primary outcome measure | Sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI) at baseline and after 30 days |
| Secondary outcome measures | Subjective mood measured using the Profile of Mood States (POMS) at baseline and after 30 days |
| Overall study start date | 12/12/2020 |
| Completion date | 31/08/2021 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Total final enrolment | 33 |
| Key inclusion criteria | 1. Adults aged between 18 and 65 in good health 2. Willing to use only the products to be tested throughout the study period 3. Willing not to use similar products that could interfere with the product to be tested 4. Willing not to change normal daily routine (e.g. lifestyle, physical activity, etc) |
| Key exclusion criteria | 1. Subjects with known or suspected sensitization to one or more ingredients of the formulation in question 2. Subjects unable to communicate or collaborate with the investigator due to language problems, intellectual disability, or impaired brain function 3. People suffering from psychiatric disorders such as schizophrenia, or psychotic disorders such as bipolar disorder or substance use disorder 4. Use of herbal remedies or psychotropic drugs intended for depression taken in the last 2 weeks before baseline or during the study 5. Receive counseling or psychological therapy at the beginning or during the study 6. Participation in any clinical trial in the previous 3 months prior to baseline 7. Subjects who plan to take antibiotics during the treatment period |
| Date of first enrolment | 25/03/2021 |
| Date of final enrolment | 31/05/2021 |
Locations
Countries of recruitment
- Italy
Study participating centre
Rende (CS)
87036
Italy
Sponsor information
University/education
via P.Bucci
Rende (CS)
878036
Italy
| Phone | +39 (0)984493109 |
|---|---|
| dipartimento.farmacia@pec.unical.it | |
| Website | http://www.unical.it |
"ROR" |
https://ror.org/02rc97e94 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Università della Calabria Campus di Arcavacata, University of Calabria, University of Calabria - Arcavacata Campus, Universidad de Calabria, UNICAL
- Location
- Italy
Results and Publications
| Intention to publish date | 31/08/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in peer-reviewed journal and presentation to scientific congresses within 1 year from study end. |
| IPD sharing plan | Trial data will not be made available due to Italian regulations on data protection. Data will be held at DFSSN – University of Calabria, Rende, Italy. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 04/05/2021 | No | Yes | ||
| Protocol file | 04/05/2021 | No | No | ||
| Results article | 20/04/2023 | 12/06/2023 | Yes | No |
Additional files
- ISRCTN15033071_PIS.pdf
- uploaded 04/05/2021
- ISRCTN15033071_PROTOCOL.pdf
- uploaded 04/05/2021
Editorial Notes
12/06/2023: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
04/05/2021: The following changes were made to the trial record:
1. Uploaded protocol (not peer-reviewed) as an additional file. Version n/a, no date.
2. The participant information sheet was uploaded as an additional file.
29/04/2021: Trial's existence confirmed by the Comitato Etico di Ateneo, University of Calabria.
