← Back to Search

Probiotic

Probiotics for Bipolar Disorder

Phase 2
Waitlist Available
Led By Faith Dickerson, PhD, MPH
Research Sponsored by Sheppard Pratt Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-65 (inclusive)
Be older than 18 years old
Must not have
Receipt of Electroconvulsive therapy (ECT) in the 30 days prior to the Visit 1/Baseline visit or planned ECT after hospital discharge
Depressive symptoms better accounted for by a diagnosis of Major Depressive Disorder, Schizoaffective disorder, Schizophrenia, or disorder(s) other than Bipolar Disorder I or II
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 12, week 24
Awards & highlights

Summary

This trial will test whether taking a probiotic supplement helps people with bipolar depression who have been recently hospitalized.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While not specified here, common side effects of probiotics may include digestive discomfort such as gas or bloating. Placebos typically have no active ingredients but can cause side effects based on participants' expectations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have not had electroconvulsive therapy in the last 30 days nor plan to after leaving the hospital.
Select...
My depression is not due to bipolar disorder but another mental health condition.
Select...
I have a serious condition affecting my brain or thinking.
Select...
I am experiencing mood changes due to medication or substance use.
Select...
I have been diagnosed with celiac disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 12, week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 12, week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to Relapse
Secondary study objectives
Brief Psychiatric Rating Scale
Columbia-Suicide Severity Rating Scale
Hamilton Depression Rating Scale
+3 more
Other study objectives
Intestinal Inflammation

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Probiotic SupplementExperimental Treatment1 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 CompoundPlacebo Group1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Probiotic Supplement
2006
N/A
~180

Find a Location

Who is running the clinical trial?

Sheppard Pratt Health SystemLead Sponsor
22 Previous Clinical Trials
7,764 Total Patients Enrolled
Faith Dickerson, PhD, MPHPrincipal InvestigatorSheppart Pratt Health System
3 Previous Clinical Trials
198 Total Patients Enrolled

Media Library

Probiotic Supplement (Probiotic) Clinical Trial Eligibility Overview. Trial Name: NCT03349528 — Phase 2
Depression, Bipolar Disorder Research Study Groups: Probiotic Supplement, Inert Compound
Depression, Bipolar Disorder Clinical Trial 2023: Probiotic Supplement Highlights & Side Effects. Trial Name: NCT03349528 — Phase 2
Probiotic Supplement (Probiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03349528 — Phase 2
~2 spots leftby Dec 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top