What side effects are associated with this type of intervention?

Common treatments for Bipolar Disorder include mood stabilizers (e.g., lithium), antipsychotics (e.g., risperidone), and adjunctive therapies like probiotics. Lithium can cause side effects such as tremor, increased thirst, diarrhea, and subclinical hypothyroidism. Antipsychotics may lead to weight gain, metabolic syndrome, and extrapyramidal symptoms. Probiotics, like those studied in adjunctive therapy, are generally well-tolerated but can occasionally cause gastrointestinal symptoms such as bloating and gas. The trial on adjunctive probiotic therapy aims to explore the modulation of gut microbiota and inflammatory markers, which may offer a novel approach with potentially fewer side effects.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Bipolar Disorder, including mood stabilizers like lithium and anticonvulsants such as valproate and lamotrigine. Atypical antipsychotics like risperidone, olanzapine, and quetiapine are also commonly used. While probiotics are not yet FDA-approved for Bipolar Disorder, the trial on adjunctive probiotic therapy aims to explore their potential in modulating gut microbiota and inflammatory markers, which could offer a novel approach to managing the condition.

What other types of research exist?

Promising novel alternatives to adjunctive probiotic therapy for bipolar disorder patients include omega-3 fatty acids, which have shown clinical benefits in reducing manic symptoms and impulsivity, and celecoxib, an anti-inflammatory drug that has demonstrated greater improvement in manic symptoms when used as an adjunctive treatment. Additionally, magnesium orotate may offer benefits through gut-brain axis modulation.

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Probiotics for Bipolar Disorder

Phase 2

Recruiting

Led By Sherwood Brown, MD, PhD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Primary Axis I diagnosis (DSM-5) at time of admission of bipolar I (single manic episode, most recent episode manic, or most recent episode mixed) OR schizoaffective disorder, bipolar type (manic or mixed state)

Be older than 18 years old

Must not have

HIV infection or other immunodeficiency condition (such as receiving cancer chemotherapy)

History of weight loss surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Summary

This trial tests if taking capsules with good bacteria can help people who were hospitalized for severe mood episodes avoid being hospitalized again. The capsules aim to improve gut health, which might reduce body inflammation and help with mental health. The study will also look at changes in mood, psychiatric symptoms, and cognitive abilities.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, previous trials using similar doses of these probiotics were well-tolerated by participants with schizophrenia or mania without significant adverse effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with bipolar I or schizoaffective disorder, bipolar type.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have HIV or another condition that weakens my immune system.

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I have had weight loss surgery in the past.

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I am experiencing mania due to medication or substance use.

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I have not had major surgery in the past year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Relapse rate

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Probiotic-Probio-Tec BG-VCap-6.5Experimental Treatment1 Intervention

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.

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive capsules containing placebo for 24-weeks.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Bipolar Disorder include mood stabilizers (e.g., lithium), antipsychotics, and adjunctive therapies such as probiotics. Mood stabilizers work by balancing neurotransmitter levels, reducing the frequency and severity of mood swings. Antipsychotics help manage symptoms of mania and psychosis by altering dopamine and serotonin pathways. Adjunctive probiotic therapy, as studied in the trial, aims to modulate gut microbiota and reduce inflammation, which may influence mood regulation and overall mental health. This approach is significant for Bipolar Disorder patients as it offers a potential new avenue for treatment that targets the gut-brain axis, potentially improving psychiatric symptoms and reducing relapse rates.

One Giant Leap from Mouse to Man: The Microbiota-Gut-Brain Axis in Mood Disorders and Translational Challenges Moving towards Human Clinical Trials.Nutrition-based interventions for mood disorders.