NCT03349528Active, not recruitingPhase 2
Probiotics to Prevent Relapse After Hospitalization for Bipolar Depression
A Double-Blind Placebo-Controlled Trial of a Probiotic Supplement to Prevent Relapse and Improve the Clinical Course After Hospitalization for Bipolar Depression
Source: ClinicalTrials.gov · Last updated 7 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 17 Nov 2017
- Start date
- 11 Dec 2018
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Sheppard Pratt Health System
- Diseases
- Bipolar disorder
- NCT number
- NCT03349528
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 80
- From 11 Dec 2018 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- DSM-5 diagnosis of intellectual disability or comparable diagnosis determined by previous version of the DSM
- DSM-5 diagnosis of a moderate or severe substance use disorder, except for caffeine or tobacco, within three months prior to the Visit 1/Baseline visit
- Participated in any investigational drug trial in the 30 days prior to the Visit 1/Baseline visit
- Receipt of Electroconvulsive therapy (ECT) in the 30 days prior to the Visit 1/Baseline visit or planned ECT after hospital discharge
Other illness
- 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
- History of IV drug use
- Any clinically significant or poorly controlled medical disorder as determined by the principal investigator and/or the study physician (e.g., HIV infection or other immunodeficiency condition, uncontrolled diabetes, congestive heart failure)
- A serious medical condition that affects brain or cognitive functioning (e.g., epilepsy, serious head injury, concussion involving loss of consciousness, brain tumor, or other neurological disorder)
- Documented celiac disease
Other
- Substance- or medically-induced mood symptoms at time of Visit 1/Baseline visit
- Pregnant, planning to become pregnant, or breastfeeding during the study period
Who the study is looking for
- Age 18-65 (inclusive)
- Capacity for written informed consent
- Currently (or within the last 3 weeks) admitted to a Sheppard Pratt inpatient or day hospital program for symptoms of a depressive episode and a diagnosis Bipolar Disorder I or II, most recent episode depressed per Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5), the diagnosis of which is confirmed with the Structured Clinical Interview for DSM-5 Disorders (SCID-5)
- Proficient in the English language
- Available to come to Sheppard Pratt Towson for study visits after hospital discharge
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sheppart Pratt Health System Coordinator of this site? Confirm its status | Towson | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.