Work-related stress Mental and Behavioural Disorders Other physical and mental strain related to work
Conditions
Interventions
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 BB0
Sponsors
University of Calabria
Eligibility
Sex/Gender
All
Inclusion criteria
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)
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI) at baseline and after 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Subjective mood measured using the Profile of Mood States (POMS) at baseline and after 30 days | — |
Countries
Italy
Outcome results
None listed