Gut health may help bipolar depression recovery
NCT ID NCT03349528
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether taking a daily probiotic supplement can help people who were recently hospitalized for bipolar depression avoid another episode. 80 adults aged 18-65 will be randomly assigned to receive either the probiotic or a placebo pill for several months. Researchers will track how long it takes before someone needs to be rehospitalized, and count any new mood episodes that occur.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2018
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * DSM-5 diagnosis of intellectual disability or comparable diagnosis determined by previous version of the DSM * Substance- or medically-induced mood symptoms at time of Visit 1/Baseline visit * 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 * 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) * Pregnant, planning to become pregnant, or breastfeeding during the study period * Documented celiac disease * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Sheppart Pratt Health System
Towson, Maryland, 21204, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Brain wave patterns and inflammation: a clue to ECT's effectiveness in older adults?
- Could a common antibiotic and supplement lift bipolar depression?