Bipolar DisorderNCT01731171

Probiotics to Prevent Relapse After Hospitalization for Mania

A study testing Probiotic Supplement and Inert Compound in people with Bipolar Disorder and Schizoaffective Disorder, run by Sheppard Pratt Health System at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Bipolar Disorder, Schizoaffective Disorder
What is being tested?: Probiotic Supplement and Inert Compound
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 66 participants
Where: 1 siteUnited States
Study dates: Nov 2012to Dec 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Sheppard Pratt Health System
Baltimore, Maryland, 21285

Other trials in United States

About this study

Official title: A Double-Blind Placebo-Controlled Trial of a Probiotic Supplement to Prevent Relapse and Improve the Clinical Course After Hospitalization for Mania

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.

Conditions: Bipolar Disorder, Schizoaffective Disorder
Being tested: Probiotic Supplement, Inert Compound
Keywords: mania, manic episode, mixed episode, bipolar disorder, schizoaffective disorder, probiotics, probiotic supplement, relapse prevention, new mood episode, re-hospitalization
Medical subject headings: Bipolar Disorder, Psychotic Disorders, Mania

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Probiotic SupplementDietary supplement
Also called Probio-Tec
Probiotic Supplement 1 tablet by mouth daily
Inert CompoundDietary supplement
Probiotic identical placebo 1 tablet by mouth daily

Study groups in NCT01731171
Study group	Role	What they receive
Probiotic Supplement	Experimental	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. Receives: Dietary Supplement: Probiotic Supplement
Inert Compound	Placebo comparator	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. Receives: Dietary Supplement: Inert Compound

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to First Rehospitalization
The primary outcome was the time to first psychiatric inpatient rehospitalization.
Measured: Weeks 0 - 24 of study participation

Secondary outcomes (3)

Number of Participants Rehospitalized
This is a count of the participants who had at least one rehospitalization during the study period.
Measured: Weeks 0 - 24 of study participation
Total Number of Rehospitalizations
This is a count of the number of rehospitalizations in each group during the study period.
Measured: Weeks 0 - 24 of study participation
Mean Days Rehospitalized
This is the mean number of days rehospitalized for participants in each group during the study period.
Measured: Weeks 0 - 24 of study participation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2012Dec 2016

First posted21 Nov 2012 (estimated)
Study startNov 2012
Primary completionDec 2016
Study completionDec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Bipolar DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01731171
Sponsor's protocol ID: SMRI/SPHS: 2012/1
Status last verified: Jan 2019
First submitted: 15 Nov 2012
Last updated: 7 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

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.
PubMed 29693757

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind Placebo-Controlled Trial of a Probiotic Supplement to Prevent Relapse and Improve the Clinical Course After Hospitalization for Mania
ClinicalTrials.gov ID: NCT01731171
Acronym / sponsor ID: SMRI/SPHS: 2012/1
Conditions: Bipolar Disorder, Schizoaffective Disorder
Keywords: mania, manic episode, mixed episode, bipolar disorder, schizoaffective disorder, probiotics, probiotic supplement, relapse prevention
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Sheppard Pratt Health SystemUniversity, hospital or other
Collaborators: Stanley Medical Research Institute
Study start: Nov 2012 (actual)
Primary completion: Dec 2016 (actual)
Study completion: Dec 2016 (actual)
First posted: 21 Nov 2012 (estimated)
Results: Posted 7 Jan 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Probiotic Supplement	Experimental	Dietary Supplement: Probiotic SupplementThe 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.
Inert Compound	Placebo comparator	Dietary Supplement: Inert CompoundThe 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Probiotic SupplementAlso: Probio-TecProbiotic Supplement 1 tablet by mouth daily	Dietary supplement	Probiotic Supplement
Inert CompoundProbiotic identical placebo 1 tablet by mouth daily	Dietary supplement	Inert Compound

Primary outcome

Time to First Rehospitalization
Time frame: Weeks 0 - 24 of study participation
The primary outcome was the time to first psychiatric inpatient rehospitalization.

3 secondary outcomes

Number of Participants Rehospitalized
Time frame: Weeks 0 - 24 of study participation
Total Number of Rehospitalizations
Time frame: Weeks 0 - 24 of study participation
Mean Days Rehospitalized
Time frame: Weeks 0 - 24 of study participation

Results and safety

Results posted to the registry on 7 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Probiotic Supplement	33	26
Inert Compound	33	26

Primary outcome: Time to First Rehospitalization

Time frame: Weeks 0 - 24 of study participation. Median (Inter-Quartile Range). Unit: Days to first readmission

Measure	Probiotic Supplement n = 33	Inert Compound n = 33
Value	168 (134 to 169)	139 (32 to 168)

Probiotic Supplement vs Inert Compound: Cox Proportional Hazard: 0.37, p =.029, Regression, Logistic

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data are presented for the treatment phase (Weeks 0 - 24) of the trial.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Probiotic Supplement	8 of 33 (24.2%)	31 of 33 (93.9%)	0 of 33
Inert Compound	17 of 33 (51.5%)	29 of 33 (87.9%)	0 of 33

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29693757Dickerson 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.
Individual participant dataSharing planned: No

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Not yet recruitingObservational study
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Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Faith Dickerson, PhD, MPH principal investigator

Sheppard Pratt Health System

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Probiotic Supplement and Inert Compound in people with Bipolar Disorder and Schizoaffective Disorder, run by Sheppard Pratt Health System at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to First Rehospitalization (time frame: Weeks 0 - 24 of study participation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01731171, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2019.