Probiotics for Bipolar Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether a probiotic supplement can reduce relapse and improve outcomes for individuals hospitalized for bipolar depression. Participants will take either a probiotic capsule or a placebo daily for 24 weeks. The trial targets individuals recently admitted to a Sheppard Pratt program for bipolar disorder with a depressive episode. Those dealing with bipolar depression and who have had a recent hospital stay might find this trial suitable. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
Is there any evidence suggesting that the probiotic supplement is likely to be safe for humans?
Research has shown that probiotics, like those used in this trial, are generally safe and easy to tolerate. Studies have found that probiotic supplements can improve psychiatric symptoms and reduce the chances of rehospitalization in people with bipolar disorder, potentially offering benefits without serious side effects.
Participants who have taken probiotics before reported very few negative side effects. The specific probiotics in this trial, Lactobacillus rhamnosus LGG® and Bifidobacterium animalis subsp. lactis BB-12®, have been used in other studies and found to be safe for consumption.
Overall, evidence suggests that probiotics can be a safe option for people with bipolar disorder, although individual experiences may vary.12345Why do researchers think this study treatment might be promising for bipolar disorder?
Most treatments for bipolar disorder involve mood stabilizers, antipsychotics, or antidepressants, which primarily target neurotransmitter imbalances. Unlike the standard of care, which often relies on these medications, the probiotic supplement uses live beneficial bacteria, specifically Lactobacillus rhamnosus LGG® and Bifidobacterium animalis subsp. lactis BB-12®. Researchers are excited about this treatment because it targets the gut-brain axis, a novel approach that may influence mental health by improving gut health. This innovative mechanism could offer a more natural alternative and potentially fewer side effects compared to traditional medications.
What evidence suggests that this probiotic supplement might be an effective treatment for bipolar disorder?
This trial will compare the effects of a Probiotic Supplement with an Inert Compound placebo in participants with bipolar disorder. Research suggests that probiotics might improve symptoms in people with bipolar disorder. Some studies have shown significant improvements in mental health symptoms with probiotic use. One study found that probiotics may reduce inflammation and enhance gut health, potentially benefiting mood disorders like bipolar disorder. Another study noted a slight improvement in cognitive skills for those taking probiotics. While not all studies have shown clear benefits, early results are promising for using probiotics to help manage bipolar disorder.12346
Who Is on the Research Team?
Faith Dickerson, PhD, MPH
Principal Investigator
Sheppart Pratt Health System
Are You a Good Fit for This Trial?
This trial is for adults aged 18-65 who have been hospitalized for bipolar depression and can visit Sheppard Pratt Towson post-discharge. Participants must be fluent in English, able to consent, and diagnosed with Bipolar Disorder I or II. Exclusions include other mental disorders, substance abuse, significant medical conditions affecting the brain, pregnancy/breastfeeding women, recent investigational drug use or ECT treatment.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either a probiotic supplement or placebo daily for 24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Inert Compound
- Probiotic Supplement
Probiotic Supplement is already approved in European Union, United States, Canada, Japan for the following indications:
- Supportive therapy for gastrointestinal health
- Prevention of antibiotic-associated diarrhea
- Dietary supplement for gut health
- Prevention of necrotizing enterocolitis in preterm infants
- Natural health product for digestive health
- Supportive therapy for irritable bowel syndrome
- Food for specified health uses (FOSHU) for gut health
- Prevention of allergic diseases
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sheppard Pratt Health System
Lead Sponsor