Back to resultsProbiotics to Prevent Relapse After Hospitalization for Mania
Primary Purpose
Bipolar Disorder, Schizoaffective Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Probiotic Supplement
Inert Compound
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder focused on measuring mania, manic episode, mixed episode, bipolar disorder, schizoaffective disorder, probiotics, probiotic supplement, relapse prevention, new mood episode, re-hospitalization
Eligibility Criteria
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.
Sites / Locations
- Sheppard Pratt Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Probiotic Supplement
Inert Compound
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Time to First Rehospitalization
The primary outcome was the time to first psychiatric inpatient rehospitalization.
Secondary Outcome Measures
Number of Participants Rehospitalized
This is a count of the participants who had at least one rehospitalization during the study period.
Total Number of Rehospitalizations
This is a count of the number of rehospitalizations in each group during the study period.
Mean Days Rehospitalized
This is the mean number of days rehospitalized for participants in each group during the study period.
Full Information
NCT ID
NCT01731171
First Posted
November 15, 2012
Last Updated
January 2, 2019
Sponsor
Sheppard Pratt Health System
Collaborators
Stanley Medical Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01731171
Brief Title
Probiotics to Prevent Relapse After Hospitalization for Mania
Official Title
A Double-Blind Placebo-Controlled Trial of a Probiotic Supplement to Prevent Relapse and Improve the Clinical Course After Hospitalization for Mania
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
November 2012 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheppard Pratt Health System
Collaborators
Stanley Medical Research Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Schizoaffective Disorder
Keywords
mania, manic episode, mixed episode, bipolar disorder, schizoaffective disorder, probiotics, probiotic supplement, relapse prevention, new mood episode, re-hospitalization
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Probiotic Supplement
Arm Type
Experimental
Arm Description
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.
Arm Title
Inert Compound
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic Supplement
Other Intervention Name(s)
Probio-Tec
Intervention Description
Probiotic Supplement 1 tablet by mouth daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Inert Compound
Intervention Description
Probiotic identical placebo 1 tablet by mouth daily
Primary Outcome Measure Information:
Title
Time to First Rehospitalization
Description
The primary outcome was the time to first psychiatric inpatient rehospitalization.
Time Frame
Weeks 0 - 24 of study participation
Secondary Outcome Measure Information:
Title
Number of Participants Rehospitalized
Description
This is a count of the participants who had at least one rehospitalization during the study period.
Time Frame
Weeks 0 - 24 of study participation
Title
Total Number of Rehospitalizations
Description
This is a count of the number of rehospitalizations in each group during the study period.
Time Frame
Weeks 0 - 24 of study participation
Title
Mean Days Rehospitalized
Description
This is the mean number of days rehospitalized for participants in each group during the study period.
Time Frame
Weeks 0 - 24 of study participation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faith Dickerson, PhD, MPH
Organizational Affiliation
Sheppard Pratt Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheppard Pratt Health System
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21285
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29693757
Citation
Dickerson F, Adamos M, Katsafanas E, Khushalani S, Origoni A, Savage C, Schweinfurth L, Stallings C, Sweeney K, Goga J, Yolken RH. Adjunctive probiotic microorganisms to prevent rehospitalization in patients with acute mania: A randomized controlled trial. Bipolar Disord. 2018 Nov;20(7):614-621. doi: 10.1111/bdi.12652. Epub 2018 Apr 25.
Results Reference
derived
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Probiotics to Prevent Relapse After Hospitalization for Mania
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