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

80 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine if taking a probiotic supplement versus a placebo will reduce relapse and improve the clinical course among participants who have been hospitalized for bipolar depression.

Research Team

Faith Dickerson, PhD, MPH

Principal Investigator

Sheppart Pratt Health System

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+