Probiotics for Bipolar Disorder

Overseen By Alejandro Cabrera-Aguirre, MBBS

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: HIV, Neurological disorder, Substance use, others

Stay on Your Current Meds You can continue your current medications while participating

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

66 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Probio-Tec BG-VCap-6.5 for bipolar disorder?

Research suggests that probiotics may help reduce inflammation and improve some psychiatric symptoms in bipolar disorder, although results are not always significant. Probiotics have shown potential in improving gut health and reducing cognitive reactivity to sad moods, which might indirectly benefit mental health. ^{1 2 3 4 5}

Is the probiotic treatment Probio-Tec BG-VCap-6.5 safe for humans?

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. Some participants reported mild digestive changes, like reduced gas and easier bowel movements, while a few experienced discomfort such as gas and constipation. ^{1 2 3 6 7}

How do probiotics differ from other treatments for bipolar disorder?

Probiotics are unique in treating bipolar disorder because they focus on modulating the gut microbiome, which may influence mental health by reducing inflammation and oxidative stress. Unlike traditional medications, probiotics are supplements that can be taken daily and may improve both gastrointestinal and psychiatric symptoms. ^{1 2 3 6 7}

Research Team

Sherwood Brown, MD, PhD

Principal Investigator

UT Southwestern Medical Center

Eligibility Criteria

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

I can understand and sign the consent form.

I can attend all required follow-up visits.

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

Exclusion Criteria

You have used illegal drugs by injecting them into your veins.

You have been diagnosed with a significant learning disability or intellectual disability.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive adjunctive probiotic or placebo therapy for 24 weeks following hospital discharge

24 weeks

Regular visits for monitoring and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

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.

Participant Groups

Group I: Probiotic-Probio-Tec BG-VCap-6.5 Experimental Treatment 1 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: Placebo Placebo Group 1 Intervention

Participants will receive capsules containing placebo for 24-weeks.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Probiotic Treatment in Individuals with Euthymic Bipolar Disorder: A Pilot-Study on Clinical Changes and Compliance. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

The Effect of Adjunctive Probiotics on Markers of Inflammation and Oxidative Stress in Bipolar Disorder: A Double-blind, Randomized, Controlled Trial. [2023]

3. Iran pubmed.ncbi.nlm.nih.gov

The Efficacy of Probiotics for Treatment of Bipolar Disorder-Type 1: A Randomized, Double-Blind, Placebo Controlled Trial. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Role of the gut microbiome in three major psychiatric disorders. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Dysregulation of the gut-brain axis in schizophrenia and bipolar disorder: probiotic supplementation as a supportive treatment in psychiatric disorders. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Probiotic Supplements on Oxidative Stress Biomarkers in First-Episode Bipolar Disorder Patients: A Randomized, Placebo-Controlled Trial. [2022]

7. Denmark pubmed.ncbi.nlm.nih.gov

Adjunctive probiotic microorganisms to prevent rehospitalization in patients with acute mania: A randomized controlled trial. [2022]