NCT05762887Completed
Clinical Evaluation of the Antidepressant Effect of the Use of Probiotics in Bipolar Disorder
Clinical Evaluation of the Antidepressant Effect of the Use of Probiotics in Bipolar Disorder and Possible Mediating Effects of Systemic and Intestinal Inflammatory Markers in the Microbiota
Source: ClinicalTrials.gov · Last updated 13 May 2026
Brief summary (registry, in English)
Bipolar Disorder (BD) is highly incapacitating and associated with premature mortality. Depressive symptoms and episodes are the most frequent cause of disability in subjects with BD and over half of patients do not respond adequately to approved treatments for this condition, showing the need for new classes of treatments to complement current pharmacotherapy. Previous studies demonstrated that the intestinal flora have potential positive or negative effects on the Central Nervous System and suggest that adding specific strains of bacteria to people's diet may have antidepressant properties.The study proposes to evaluate the clinical benefit of adding probiotics to pharmacological treatments for bipolar depression. This will be a study with 124 subjects (62 receiving probiotics and 62 placebo). The research team in this department has focused especially on non-pharmacological treatments for bipolar disorder (psychotherapy, nutrition and exercise) and is multidisciplinary in scope with psychiatrists, psychologists, nurses, physiotherapists and nutritionists participating in research projects.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 141 (actual)
- First submitted
- 11 Jan 2023
- Start date
- 9 Jan 2023
- Primary completion date
- 1 Mar 2025
- Lead sponsor
- University of Sao Paulo
- Diseases
- Bipolar disorder
- NCT number
- NCT05762887
What you commit to
- Study type: Interventional
- Participants enrolled: 141
- From 9 Jan 2023 to the primary completion date, 1 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients on prolonged antibiotic therapy, immunosuppressive therapies
Other
- Pregnant or lactating women
- Substance or alcohol dependence
- A recent introduction of antidepressants in the last 15 days
- Use of another probiotic, either in the form of food, sachets, capsules and others
Who the study is looking for
- BD type I or type II, according to the use of Mini Internacional Neuropsychiatric Interview (MINI)
- Score on the Young Mania Rating Scale (YMRS) \< 8
- Score on the Montgomery-Asberg Depression Rating Scale (MADRS) \> 8
- Be receiving major guideline-approved treatments for bipolar depression for at least 4 weeks
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Sao Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.