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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 belowSelect...
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:Select...
I have HIV or another condition that weakens my immune system.
Select...
I have had weight loss surgery in the past.
Select...
I am experiencing mania due to medication or substance use.
Select...
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
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.
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.
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.
Find a Location
Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,077 Previous Clinical Trials
1,055,995 Total Patients Enrolled
19 Trials studying Bipolar Disorder
10,303 Patients Enrolled for Bipolar Disorder
Sherwood Brown, MD, PhDPrincipal Investigator - UT Southwestern Medical Center
University of Texas Southwestern Medical Center
6 Previous Clinical Trials
735 Total Patients Enrolled
2 Trials studying Bipolar Disorder
230 Patients Enrolled for Bipolar Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I have had weight loss surgery in the past.I can understand and sign the consent form.Your liver enzymes (AST and ALT) are more than three times the normal limit.I can attend all required follow-up visits.I am experiencing mania due to medication or substance use.I have been diagnosed with bipolar I or schizoaffective disorder, bipolar type.I was hospitalized for mania symptoms within the last 3 weeks.You have been diagnosed with a moderate or severe alcohol or drug problem in the past 3 months, or have recently tested positive for drugs.Your body has unusual levels of minerals like sodium, potassium, or calcium in your blood.I have not had major surgery in the past year.I have been diagnosed with celiac disease and follow a gluten-free diet.I have a condition affecting my brain function, but not acute Hepatitis-C.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Probiotic-Probio-Tec BG-VCap-6.5
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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