Probiotics to Prevent Relapse After Hospitalization for Mania

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01731171
Recruitment Status : Completed
First Posted : November 21, 2012
Last Update Posted : September 25, 2017
Stanley Medical Research Institute
Information provided by (Responsible Party):
Faith Dickerson, PhD, MPH, Sheppard Pratt Health System

Brief Summary:
The purpose of this study is to determine if taking a probiotic supplement versus a placebo will lower rates of relapse and improve the clinical course among participants who have been hospitalized for mania. Relapse and clinical course are measured by time to re-hospitalizations, new mood episodes, and changes in mood-related symptoms.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Schizoaffective Disorder Dietary Supplement: Probiotic Supplement Dietary Supplement: Inert Compound Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind Placebo-Controlled Trial of a Probiotic Supplement to Prevent Relapse and Improve the Clinical Course After Hospitalization for Mania
Actual Study Start Date : November 2012
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Probiotic Supplement
The probiotic supplement compound will consist of capsules containing approximately 10^8 colony forming units of the probiotic organisms, LactobacillusGG and Bifidobacteria lactis strain Bb12. The capsule, which will be swallowed, is a size 3 opaque, hard, hypromellose capsule. The participant will be asked to take 1 capsule of the probiotic supplement with a meal or with a snack daily for 24 weeks.
Dietary Supplement: Probiotic Supplement
Probiotic Supplement 1 tablet by mouth daily
Other Name: Probio-Tec

Placebo Comparator: Inert Compound
The inert compound placebo looks identical to the probiotic supplement, and participants will be instructed to swallow 1 capsule with a meal or with a snack daily for 24 weeks.
Dietary Supplement: Inert Compound
Probiotic identical placebo 1 tablet by mouth daily

Primary Outcome Measures :
  1. Time to relapse [ Time Frame: Weeks 1 - 24 of study participation ]
    Time to relapse is defined as time until rehospitalization during the study period after a minimum of a 3 day interval after discharge from a previous hospital stay.

Secondary Outcome Measures :
  1. New mood episode [ Time Frame: Weeks 1 - 24 of study participation ]
    New mood episodes are defined by DSM-IV criteria for a manic, mixed, or depressive episode.

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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

Inclusion Criteria:

  • Age 18-65
  • Capacity for written informed consent
  • Currently admitted to a Sheppard Pratt inpatient or day hospital for symptoms of mania
  • Primary Axis I diagnosis (DSM-IV) at time of admission of Bipolar I Disorder (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 come to Sheppard Pratt Towson for follow-up visits
  • Participated previously in one of our screening studies

Exclusion Criteria:

  • Diagnosis of mental retardation
  • Symptoms of mania secondary to a general medical condition
  • Any clinically significant or unstable medical disorder as determined by the investigators including congestive heart failure, abnormal liver function or disease, renal failure, acute pancreatitis, any diagnosis of cancer undergoing active treatment, HIV infection or other immunodeficiency condition
  • History of IV drug use
  • Primary diagnosis of substance abuse or dependence according to DSM-IV criteria within the last 3 months, or has a positive drug toxicity screen
  • Participated in any investigational drug trial in the past 30 days
  • Pregnant or planning to become pregnant during the study period
  • Receipt of antibiotic medication within the previous 24 hours (as anaerobic organisms residing in the gastrointestinal tract may be minimally affected by antibiotics)
  • 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.

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 identifier (NCT number): NCT01731171

United States, Maryland
Sheppard Pratt Health System
Baltimore, Maryland, United States, 21285
Sponsors and Collaborators
Sheppard Pratt Health System
Stanley Medical Research Institute
Principal Investigator: Faith Dickerson, PhD, MPH Sheppard Pratt Health System

Responsible Party: Faith Dickerson, PhD, MPH, Head, Stanley Research Program, Sheppard Pratt Health System Identifier: NCT01731171     History of Changes
Other Study ID Numbers: SMRI/SPHS: 2012/1
First Posted: November 21, 2012    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Faith Dickerson, PhD, MPH, Sheppard Pratt Health System:
manic episode
mixed episode
bipolar disorder
schizoaffective disorder
probiotic supplement
relapse prevention
new mood episode

Additional relevant MeSH terms:
Bipolar Disorder
Psychotic Disorders
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Disease Attributes
Schizophrenia Spectrum and Other Psychotic Disorders