Probiotics for Bipolar Disorder

Recruiting in Palo Alto (17 mi)

Overseen BySherwood Brown, MD, PhD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: University of Texas Southwestern Medical Center

Stay on your current meds

Pivotal Trial (Near Approval)

Prior Safety Data

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.

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

Exclusion Criteria

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

I have had weight loss surgery in the past.

I am experiencing mania due to medication or substance use.

I have not had major surgery in the past year.

Participant Groups

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.

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.