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
University of Texas 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
Trial Overview
The study tests a high-dose probiotic (Probio-Tec BG-VCap-6.5) against a placebo over 24 weeks in individuals after hospitalization for mania. The goal is to see if the probiotics can prevent relapse—defined as re-hospitalization due to psychiatric symptoms—and monitor mood episodes severity and cognitive changes.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive capsules containing approximately 10\^9 colony forming units of the probiotic organisms, Lactobacillus GG and Bifidobacteria lactis strain Bb12 for 24-weeks.
Participants will receive capsules containing placebo for 24-weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Texas Southwestern Medical Center
Lead Sponsor
Citations
Probiotics for Bipolar Disorder · Info for Participants
Probiotic treatments, including those similar to Probio-Tec BG-VCap-6.5, have generally been well-tolerated in studies with people who have bipolar disorder.
Probiotic, prebiotic, synbiotic and fermented food ...
Studies frequently focused on schizophrenia (n = 11) and bipolar disorder (n = 5) and there were limited studies in anorexia nervosa (n = 4), ADHD ( ...
The Efficacy of Probiotics for Treatment of Bipolar Disorder- ...
The aim of this study was to determine the effect of consuming probiotics in patients with bipolar disorder-type 1 compared to the placebo group.
4.
clinicaltrials.gov
clinicaltrials.gov/study/NCT03539263?term=AREA%5BBasicSearch%5D(AREA%5BConditionSearch%5D(Probiotic%20AND%20%22Depression%22)%20AND%20AREA%5BOverallStatus%5D(COMPLETED))&rank=8Study Details | Effects of Probiotics on Mood
An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...
5.
psychiatrictimes.com
psychiatrictimes.com/view/probiotics-lower-rehospitalization-rates-bipolar-disorderProbiotics Lower Rehospitalization Rates in Bipolar Disorder
The first clinical trial of probiotics in bipolar disorder is out, and the results look promising.
The Role of Probiotics and Their Metabolites in the Treatment ...
This paper aims to highlight a connection between mental and digestive health, the importance of the microbiota–gut–brain axis in depression, and the potential ...
Effectiveness of Psychobiotics in the Treatment of Psychiatric ...
The research corroborates the therapeutic potential of psychobiotics and represents progress in the management of psychiatric and cognitive disorders.
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