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A Probiotic Intervention to Prevent Relapse Following Hospitalization for Mania

Primary Purpose

Mania (Neurotic)

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Probio-Tec BG-VCap-6.5

Placebo

About this trial

This is an interventional prevention trial for Mania (Neurotic) focused on measuring Probiotic, bipolar disorder, schizoaffective disorder, mania

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Psychoneuroendocrine Research ProgramRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Probiotic-Probio-Tec BG-VCap-6.5

Arm Description

Participants will receive capsules containing placebo for 24-weeks.

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.

Outcomes

Primary Outcome Measures

Relapse rate

Rate of relapse as defined by a re-hospitalization (e.g., admission to an inpatient unit)

Secondary Outcome Measures

Full Information

NCT ID

NCT03383874

First Posted

December 19, 2017

Last Updated

October 9, 2023

Sponsor

University of Texas Southwestern Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03383874

Brief Title

A Probiotic Intervention to Prevent Relapse Following Hospitalization for Mania

Official Title

A Probiotic Intervention to Prevent Relapse Following Hospitalization for Mania

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 6, 2018 (Actual)

Primary Completion Date

July 31, 2024 (Anticipated)

Study Completion Date

September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Texas Southwestern Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mania (Neurotic)

Keywords

Probiotic, bipolar disorder, schizoaffective disorder, mania

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Participants will receive capsules containing placebo for 24-weeks.

Arm Title

Probiotic-Probio-Tec BG-VCap-6.5

Arm Type

Experimental

Arm Description

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.

Intervention Type

Combination Product

Intervention Name(s)

Probio-Tec BG-VCap-6.5

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

This placebo is made almost identically to the Probio-Tec but without active microorganisms.

Primary Outcome Measure Information:

Title

Relapse rate

Description

Rate of relapse as defined by a re-hospitalization (e.g., admission to an inpatient unit)

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alejandro Cabrera-Aguirre, MBBS

Phone

214-645-6953

alejandro.cabreraaguirre@utsouthwestern.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sherwood Brown, MD, PhD

Organizational Affiliation

UT Southwestern Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Psychoneuroendocrine Research Program

City

Dallas

State/Province

Texas

ZIP/Postal Code

75235

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alejandro Cabrera-Aguirre, MBBS

Phone

214-645-6953

alejandro.cabreraaguirre@utsouthwestern.edu

12. IPD Sharing Statement

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A Probiotic Intervention to Prevent Relapse Following Hospitalization for Mania

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