Probiotics for improving cognition in patients with bipolar disorder

Effect of Probiotic vs Placebo on Cognition Outcomes in Patients With Bipolar Disorder: A Randomized Clinical Trial

This study is testing whether taking probiotics can help improve thinking and memory in people with stable bipolar disorder.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 16 Years to 65 Years
• Sex: All
• Sponsor: First Affiliated Hospital of Zhejiang University (Academic / other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT05954598 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of probiotics on cognitive function in patients with stable bipolar disorder. A total of 100 participants will be randomly assigned to receive either probiotics or a placebo for 12 weeks. The study aims to evaluate changes in cognitive function, clinical symptoms, and potential mechanisms of action related to gut microbiome influence. Assessments will include cognitive tests, physical symptoms, sleep quality, and serum cortisol levels before and after the intervention.

Who should consider this trial

Good fit: Ideal candidates are stable bipolar disorder patients aged 16-65 who meet specific diagnostic criteria and have not taken probiotics recently.

Not a fit: Patients with acute bipolar episodes or those who have recently used probiotics or antibiotics may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a novel approach to improving cognitive function in patients with bipolar disorder.

How similar studies have performed: While the role of probiotics in mental health is emerging, this specific approach to cognitive function in bipolar disorder is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria：

1）Both biological parents were Han. 2) Age 16-65 years old, male or female; 3) The subjects met the DSM-5 clinical diagnostic criteria for bipolar disorder, and the 17-item Hamilton Depression Scale score (HAMD-17) ≤16 points, Hamilton Anxiety Scale score ≤7 points, and Young Mania Scale score ≤5 points were maintained for more than 2 months. All enrolled patients were evaluated by a professional and systematically trained psychiatrist.

4) No probiotic preparations such as yogurt were taken within 1 month before enrollment; 5) No clear history of respiratory tract, urinary system, digestive system infection or antibiotic use within 1 month before enrollment; 6) The drug regimen remained stable within 1 month before enrollment; 7) Perceived Deficits Questionnaire (PDQ) score ≥17 points; 8) Right-handed; 9) Primary school education or above; 10) Informed consent of patients and their families to this study. Exclusion Criteria：

1. Those who meet the DSM-5 diagnostic criteria for schizophrenia, depression, neurodevelopmental disorders, dementia, memory impairment, or other cognitive disabilities;
2. Those who had used ECT before enrollment;
3. Those who currently have serious suicidal thoughts or behaviors, or who are severely agitated;
4. Those who cannot follow the doctor's advice or have no guardian;
5. Pregnant or lactating women, or those planning pregnancy.
6. Patients with abnormal brain structure or any MRI contraindications found by magnetic resonance examination.
7. Mental disorders caused by substance abuse (alcohol, drugs, etc.), people with serious physical diseases, such as thyroid disease, heart disease, abnormal liver and kidney function, etc.; 8）Can not tolerate any probiotic preparations or have a history of allergy.

Where this trial is running

Hangzhou, Zhejiang

• The First Affiliated Hospital, Zhejiang University School of Medicine (FAHZU) — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Xiao Wang, MD

Conditions Bipolar Disorder