NCT03383874CompletedPhase 3
A Probiotic Intervention to Prevent Relapse Following Hospitalization for Mania
Source: ClinicalTrials.gov · Last updated 19 Dec 2025
Brief summary (registry, in English)
This will be a 24-week, randomized, double-blind, placebo-controlled trial of adjunctive probiotic therapy in 66 persons hospitalized with a manic or mixed episode. The active study compound will consist of capsules containing approximately 10\^9 colony forming units of the probiotic organisms, Lactobacillus GG and Bifidobacteria lactis strain Bb12. The dose has been selected because it has been used safely in other probiotic trials, was well-tolerated by the participants in two previous trials of individuals with schizophrenia or mania, and was utilized in the original trial on which this replication is based. This dose is higher than that available in most commercially-sold health food supplements. Following hospital discharge, participants will be randomized to receive adjunctive probiotic or placebo for a 24 week period. It is anticipated that of the 66 participants randomized, \~50 (75%) will complete the full 24 weeks of the study. The primary outcome is relapse, defined as re-hospitalization (e.g., admission to an inpatient unit) for psychiatric symptoms following a previous hospital discharge by at least 2 weeks. The occurrence of new mood episodes, the severity of psychiatric symptoms, and any changes in cognitive test scores over the course of the study will also be evaluated. Changes in the levels of inflammatory markers as well as changes in gut microbiota will be evaluated at three time intervals over the course of the study.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 67 (actual)
- First submitted
- 19 Dec 2017
- Start date
- 6 Sept 2018
- Primary completion date
- 23 Sept 2024
- Lead sponsor
- University of Texas Southwestern Medical Center
- Diseases
- Bipolar disorder
- NCT number
- NCT03383874
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 67
- From 6 Sept 2018 to the primary completion date, 23 Sept 2024
- 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
- HIV infection or other immunodeficiency condition (such as receiving cancer chemotherapy).
- Major surgery in the last year.
- Participated in any investigational drug trial in the past 30 days.
Other illness
- 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). Note that Hepatitis-C is not an exclusion criterion unless the participant has an acute infection.
- Poorly controlled comorbid medical condition.
- History of weight loss surgery.
- Diagnosis of Intellectual Disability or history of severe learning disorder.
- Diagnosis of alcohol or substance use disorder (moderate/severe) according to DSM-5 criteria within the last 3 months, or has a positive drug toxicity screen proximate to the time of recruitment.
- History of IV drug use.
- Documented celiac disease (as such persons should be on a gluten-free diet as this is the standard care). Of note, we are not limiting the study to individuals with elevated levels of gliadin or casein antibodies as we intend to look at these levels as a predictor of response.
Lab values
- AST and ALT \> 3 times upper limit of normal.
Other
- Substance- or medically-induced symptoms of mania at time of assessment.
- Abnormal electrolyte levels.
- Pregnant, breastfeeding, or planning to become pregnant during the study period.
Who the study is looking for
- Capacity for written informed consent
- Currently (or within the last 3 weeks) admitted to inpatient hospital for symptoms of mania.
- 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).
- Proficient in the English language.
- Available to attend follow-up visits.
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 |
|---|---|---|---|
| Psychoneuroendocrine Research Program Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.