A Probiotic Intervention to Prevent Relapse Following Hospitalization for Mania
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 3/9/2019 |
| Start Date: | September 6, 2018 |
| End Date: | March 2021 |
| Contact: | Brittany L Mason, PhD |
| Email: | brittany.mason@utsouthwestern.edu |
| Phone: | 214-645-6950 |
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.
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.
Primary Aim 1. To determine if adjunctive probiotic administration can reduce relapse for
participants first hospitalized for mania. Hypothesis: Participants receiving adjunctive
probiotic microorganisms vs. adjunctive placebo will have a lower rate of relapse as defined
by a re-hospitalization (e.g., admission to an inpatient unit) during the 24 week study
period.
Secondary Outcomes. The number of new mood episodes, the severity of psychiatric symptoms,
and changes in cognitive scores over the 24 week study period will be evaluated.
Exploratory Aim 1. To study the effect of probiotic therapy in lowering the levels of
inflammatory markers following an acute episode of mania. Hypothesis: Participants receiving
adjunctive probiotic microorganisms vs. adjunctive placebo will have reduced levels of
antibodies to casein, gliadin, and the NMDA receptor, and reduced levels of C-Reactive
protein and the cytokine TNF alpha following 24 weeks of probiotic therapy.
Exploratory Aim 2. To evaluate changes in the gut microbiota following probiotic
administration. Hypothesis: Probiotic administration will enrich the gut microbiota of
participants with the given microorganisms and these changes may correlate to changes in the
peripheral inflammatory markers being measured.
participants first hospitalized for mania. Hypothesis: Participants receiving adjunctive
probiotic microorganisms vs. adjunctive placebo will have a lower rate of relapse as defined
by a re-hospitalization (e.g., admission to an inpatient unit) during the 24 week study
period.
Secondary Outcomes. The number of new mood episodes, the severity of psychiatric symptoms,
and changes in cognitive scores over the 24 week study period will be evaluated.
Exploratory Aim 1. To study the effect of probiotic therapy in lowering the levels of
inflammatory markers following an acute episode of mania. Hypothesis: Participants receiving
adjunctive probiotic microorganisms vs. adjunctive placebo will have reduced levels of
antibodies to casein, gliadin, and the NMDA receptor, and reduced levels of C-Reactive
protein and the cytokine TNF alpha following 24 weeks of probiotic therapy.
Exploratory Aim 2. To evaluate changes in the gut microbiota following probiotic
administration. Hypothesis: Probiotic administration will enrich the gut microbiota of
participants with the given microorganisms and these changes may correlate to changes in the
peripheral inflammatory markers being measured.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Substance- or medically-induced symptoms of mania at time of assessment.
- HIV infection or other immunodeficiency condition (such as receiving cancer
chemotherapy).
- 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.
- 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.
- Participated in any investigational drug trial in the past 30 days.
- Pregnant, breastfeeding, or planning to become pregnant during the study period.
- 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.
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