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Effect of probiotics on mental health among adults: Randomized clinical trial in the workplace

A randomized, placebo-controlled pilot study investigating the effects of probiotics on stress, anxiety, depression, sleep disorders, fatigue, and work productivity in healthy workers.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
PACTR
Registry ID
PACTR202601861675989
Enrollment
176
Registered
2026-01-14
Start date
2025-08-27
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental and Behavioural Disorders

Interventions

Placebo
Probiotic

Sponsors

XEN Laboratoires
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - White-collar employees working in a company in Sousse, Tunisia. - aged 19–65 years at the time of informed consent. - Did not regularly take medications. - Did not have a history of serious illness (e.g., diabetes, liver disease, kidney disease, and heart disease).

Exclusion criteria

Exclusion criteria: - Participants who were under pharmacotherapy or clinical treatment for one or more serious diseases. - Those following a medically prescribed diet or exhibiting extremely unbalanced eating habits. - Individuals at risk of developing an allergy to the tested treatment. - Those receiving treatment for mental disorders (such as depression) and/or sleep disorders, or with a history of such conditions. - Individuals using sleeping medications. - Those who had taken probiotics within one month before the study. - Participants with a history of drug dependence. - Heavy drinkers (equivalent to an ethanol intake of 66 g/day). - Individuals with severe diseases such as brain disorders, malignant tumors, immune diseases, diabetes mellitus, hepatic diseases (including hepatitis), renal diseases, cardiac diseases. or serious metabolic disorders (such as thyroid or adrenal disorders), or with a history of such conditions. - Those with a history of intestinal or brain surgery or intestinal diseases other than hernia, hemorrhoids, or appendicitis. - Pregnant, lactating, or potentially pregnant women. - Those who had participated in another clinical study within three months before providing informed consent or planned to participate in another study during the present trial; individuals with irregular working hours (e.g., night shifts). - Those who might have difficulty completing the required questionnaires. - Subjects who declined to participate in the study.

Design outcomes

Primary

MeasureTime frame
Stress;Depression;Anxiety

Secondary

MeasureTime frame
Quality of sleep;quality of life caused by abdominal symptoms

Countries

Tunisia

Contacts

Public ContactOlfa EL MAALEL

Professor

elmaalelolfa@gmail.com0021655152652

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026