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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 12, week 24
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to Relapse
Secondary outcome measures
Brief Psychiatric Rating Scale
Columbia-Suicide Severity Rating Scale
Hamilton Depression Rating Scale
+3 more
Other outcome measures
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
21 Previous Clinical Trials
7,729 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To whom does this research project offer the possibility of inclusion?

"Eighty individuals that suffer from manic disorder and meet the age requirements of 18-65 years old are able to enroll in this study. Furthermore, these participants must be willing and available to visit Sheppard Pratt Towson for required check-ups."

Answered by AI

Is this research project only enrolling individuals who are under the age of seventy?

"The age requirements to participate in this trial are that applicants must be between 18-65 years old."

Answered by AI

What is the general opinion on Probiotic Supplement's safety?

"This Probiotic Supplement is still in Phase 2 of clinical trials, so there is some evidence that it is safe but not yet any indication of whether or not it actually works."

Answered by AI

Are there any patients currently enrolled in this research?

"The latest information on clinicaltrials.gov indicates that this trial is no longer recruiting patients. Although this particular study has wrapped up, there are still 2,517 other trials looking for participants."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Sheppart Pratt Health System
Recent research and studies
clinicaltrials.govStudy
Probiotics to Prevent Relapse After Hospitalization for Bipolar Depression
Faith Dickerson 2018. "Probiotics to Prevent Relapse After Hospitalization for Bipolar Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03349528.
All > Bipolar Disorder > Probiotics
~8 spots leftby Dec 2024
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