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A Probiotic Intervention to Prevent Relapse Following Hospitalization for Mania

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ClinicalTrials.gov Identifier: NCT03383874
Recruitment Status : Recruiting
First Posted : December 26, 2017
Last Update Posted : October 28, 2022
Sponsor:
Information provided by (Responsible Party):
Sherwood Brown, MD, PhD, University of Texas Southwestern Medical Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Mania (Neurotic) Combination Product: Probio-Tec BG-VCap-6.5 Other: Placebo Phase 2

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Probiotic Intervention to Prevent Relapse Following Hospitalization for Mania
Actual Study Start Date : September 6, 2018
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2024
Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Participants will receive capsules containing placebo for 24-weeks.
 Other: Placebo
This placebo is made almost identically to the Probio-Tec but without active microorganisms.
Experimental: Probiotic-Probio-Tec BG-VCap-6.5
Participants will receive capsules containing approximately 10^9 colony forming units of the probiotic organisms, Lactobacillus GG and Bifidobacteria lactis strain Bb12 for 24-weeks.
 Combination Product: Probio-Tec BG-VCap-6.5
The product under investigation is a probiotic containing two microorganisms (Lactobacillus rhamnosus, LGG® and Bifidobacterium animalis subsp. lactis, BB-12®, referred to as LGG® and BB-12®, respectively) and is offered commercially as "Probio-Tec BG-VCap-6.5". This composition is formulated to contain a minimum of 1 billion (1.0 x 10^9) CFU (Colony Forming Units) per dose (capsule), including equal numbers of the two strains; i.e. 0.5 x 10^9 CFU of each of LGG® and BB-12® at the time of manufacture. The product will be administered orally.


Outcome Measures
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Primary Outcome Measures :
  1. Relapse rate [ Time Frame: 24 weeks ]
    Rate of relapse as defined by a re-hospitalization (e.g., admission to an inpatient unit)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  • Poorly controlled comorbid medical condition.
  • Major surgery in the last year.
  • 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.
  • Participated in any investigational drug trial in the past 30 days.
  • Abnormal electrolyte levels.
  • AST and ALT > 3 times upper limit of normal.
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03383874


Contacts
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Contact: Salina Shrestha 214-645-6957 salina.shrestha@utsouthwestern.edu

Locations
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United States, Texas
Psychoneuroendocrine Research Program Recruiting
Dallas, Texas, United States, 75235
Contact: Salina Shrestha, B.S.    214-645-6957    salina.shrestha@utsouthwestern.edu   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Sherwood Brown, MD, PhD UT Southwestern Medical Center
More Information
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Responsible Party: Sherwood Brown, MD, PhD, Professor of Medicine, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03383874    
Other Study ID Numbers: STU 082017-045
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: October 28, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mania
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases