Probiotics for Bipolar Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether adding probiotics to regular treatment can help people with bipolar disorder who have recently been hospitalized for manic symptoms. Probiotics, beneficial bacteria, might improve mental health by affecting the gut. Participants will receive either probiotic capsules (Probio-Tec BG-VCap-6.5) or a placebo (a substance with no active ingredient) for 24 weeks. The study will assess the impact on relapse rates and other health markers. The trial seeks individuals recently hospitalized for mania with a primary diagnosis of bipolar I or schizoaffective disorder, bipolar type. As a Phase 3 trial, this research represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your existing treatments, as the trial involves adding probiotics to your current regimen.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that probiotics, such as those in the Probio-Tec BG-VCap-6.5 treatment, are generally safe for individuals with bipolar disorder. Past studies have involved people with conditions like schizophrenia or mania using similar amounts of these probiotics without major issues. Significant reports of negative side effects have not emerged, indicating their safety.
Moreover, earlier trials demonstrated that these probiotics helped reduce the likelihood of re-hospitalization for psychiatric symptoms. This suggests they may not only be safe but also potentially beneficial for mental health.12345Why do researchers think this study treatment might be promising for bipolar disorder?
Researchers are excited about using probiotics like Probio-Tec BG-VCap-6.5 for bipolar disorder because they offer a novel approach to treatment. Unlike traditional medications, which often target brain chemistry directly, this probiotic treatment may work by promoting gut health, which is increasingly linked to mental well-being. The active ingredients, Lactobacillus GG and Bifidobacteria lactis Bb12, are beneficial bacteria that could help balance the gut microbiome, potentially influencing mood regulation in a natural way. This approach might offer a complementary option with fewer side effects compared to standard psychiatric medications.
What evidence suggests that this probiotic treatment might be effective for bipolar disorder?
Research has shown that probiotics like Probio-Tec BG-VCap-6.5, which participants in this trial may receive, might aid individuals with bipolar disorder. Studies have found that these probiotics can reduce the likelihood of hospital readmission, suggesting they might help control symptoms after a hospital stay. In earlier studies, individuals taking probiotics similar to Probio-Tec BG-VCap-6.5 reported improvements in mood and overall mental health. This treatment uses beneficial bacteria, such as Lactobacillus GG and Bifidobacteria lactis, believed to enhance gut health. Improved gut health is linked to better mental health due to the close connection between the gut and brain. Overall, early results are promising for managing symptoms of bipolar disorder.12467
Who Is on the Research Team?
Sherwood Brown, MD, PhD
Principal Investigator
UT Southwestern Medical Center
Are You a Good Fit for This Trial?
This trial is for adults recently hospitalized for mania or mixed episodes related to bipolar I or schizoaffective disorder, bipolar type. Participants must be able to consent, speak English, and attend follow-up visits. Exclusions include immunodeficiency conditions, severe learning disorders, pregnancy, recent drug trials participation, certain medical conditions affecting the brain function and uncontrolled comorbidities.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive adjunctive probiotic or placebo therapy for 24 weeks following hospital discharge
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Probio-Tec BG-VCap-6.5
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Texas Southwestern Medical Center
Lead Sponsor