Evaluating the effects of probiotics on depression 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
NA · University of Sao Paulo · NCT05762887
This study is testing if adding probiotics to regular treatments can help people with bipolar disorder feel less depressed.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Sao Paulo (other) |
| Locations | 1 site (São Paulo, Sao Paulo) |
| Trial ID | NCT05762887 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the antidepressant effects of probiotics as an adjunct to standard pharmacological treatments in individuals with bipolar disorder. It will involve 84 participants, divided into two groups: one receiving probiotics and the other a placebo, over a 12-week period. The research will also explore potential inflammatory and metabolic markers that may correlate with treatment response. The study is designed to provide insights into non-pharmacological approaches for managing bipolar depression.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with bipolar disorder type I or II who are experiencing depressive symptoms and are currently on approved treatments.
Not a fit: Patients who are pregnant, lactating, or have substance dependence may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a novel adjunctive treatment option for patients with bipolar disorder who struggle with depressive symptoms.
How similar studies have performed: While the use of probiotics in mental health is an emerging field, previous studies have shown promising results, suggesting potential benefits in similar approaches.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Pregnant or lactating women * Substance or alcohol dependence * Patients on prolonged antibiotic therapy, immunosuppressive therapies * A recent introduction of antidepressants in the last 15 days * Use of another probiotic, either in the form of food, sachets, capsules and others
Where this trial is running
São Paulo, Sao Paulo
- University of Sao Paulo — São Paulo, Sao Paulo, Brazil (RECRUITING)
Study contacts
- Principal investigator: Beny lafer, PhD — University of Sao Paulo
- Study coordinator: Adiel Rios, MD
- Email: adiel.rios@usp.br
- Phone: 5511945084970
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bipolar Disorder