Probiotics for Bipolar Disorder

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sheppard Pratt Health System

Disqualifiers: Schizophrenia, Substance use disorder, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 24 weeks

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. ^{1 2 3 4 5}

Why 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. ^{1 2 3 4 6}

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

Proficient in the English language

I can understand and sign the consent form.

Available to come to Sheppard Pratt Towson for study visits after hospital discharge

Exclusion Criteria

Participated in any investigational drug trial in the 30 days prior to the Visit 1/Baseline visit

Pregnant, planning to become pregnant, or breastfeeding during the study period

I have not had electroconvulsive therapy in the last 30 days nor plan to after leaving the hospital.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a probiotic supplement or placebo daily for 24 weeks

24 weeks

Regular visits for assessment at baseline, week 12, and week 24

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Inert Compound
• Probiotic Supplement

Trial Overview

The study aims to see if a probiotic supplement can prevent relapse in individuals recently hospitalized for bipolar depression compared to a placebo (an inert compound). The goal is to improve their clinical outcomes after discharge from the hospital.

How Is the Trial Designed?

Group I: Probiotic Supplement Experimental Treatment 1 Intervention

The probiotic supplement will consist of capsules containing approximately 1 billion (1.0 x 10\^9) colony forming units of the probiotic organisms, Lactobacillus rhamnosus LGG® (LGG®) and Bifidobacterium animalis subsp. lactis BB-12® (BB-12®). The capsule, which will be swallowed, is a size 3 opaque, hard, hypromellose capsule. Participants will be asked to take 1 capsule of the probiotic supplement with a meal or with a snack daily for 24 weeks.

Group II: Inert Compound Placebo Group 1 Intervention

The inert compound placebo looks identical to the probiotic supplement, and participants will be instructed to swallow 1 capsule with a meal or with a snack daily for 24 weeks.

Probiotic Supplement is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Probiotics for:

• Supportive therapy for gastrointestinal health
• Prevention of antibiotic-associated diarrhea

Approved in United States as Probiotics for:

• Dietary supplement for gut health
• Prevention of necrotizing enterocolitis in preterm infants

Approved in Canada as Probiotics for:

• Natural health product for digestive health
• Supportive therapy for irritable bowel syndrome

Approved in Japan as Probiotics for:

• Food for specified health uses (FOSHU) for gut health
• Prevention of allergic diseases

Who Is Running the Clinical Trial?

Sheppard Pratt Health System

Lead Sponsor

Trials

23

Recruited

7,800+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9548122/

Recent developments in the probiotics as live biotherapeutic ...

The efficacy of probiotics for treatment of bipolar disorder-type 1: a randomized, double-blind, placebo controlled trial. Iran J Psychiatry ...

2.

academic.oup.com

academic.oup.com/schizophreniabulletin/advance-article/doi/10.1093/schbul/sbae188/7879597

Probiotic Formulation for Patients With Bipolar or ...

No significant effect of probiotics was observed on psychiatric symptoms, but borderline significant improvement was observed in the cognition ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37222849/

Probiotics, Live Biotherapeutic Products (LBPs), and Gut ...

It is thought that LBPs may positively affect depression, anxiety, bipolar disorder, and schizophrenia by reducing inflammation, improving gut microbiota, and ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S0149763424000290

Probiotic, prebiotic, synbiotic and fermented food ...

In both studies the probiotic intervention was associated with a significant improvement in psychiatric symptoms and a significant improvement in ...

5.

researchgate.net

researchgate.net/publication/327734677_The_Impact_of_Probiotic_Supplements_on_Cognitive_Parameters_in_Euthymic_Individuals_with_Bipolar_Disorder_A_Pilot_Study

The Impact of Probiotic Supplements on Cognitive ...

Conclusion: The results confirm the hypotheses that probiotic supplement might help stable individuals with BD to improve the cognitive function ...

6.

researchgate.net

researchgate.net/publication/371008619_Probiotics_Live_Biotherapeutic_Products_LBPs_and_Gut-Brain_Axis_Related_Psychological_Conditions_Implications_for_Research_and_Dietetics

Probiotics, Live Biotherapeutic Products (LBPs), and Gut ...

This review focuses on the specific position of probiotics as LBPs in psychological conditions. Condition-specific potential pathways and ...