SchizophreniaNCT01242371

Double-Blind Trial of a Probiotic Supplement to Reduce the Symptoms of Schizophrenia

A study testing Probiotic Supplement in people with Schizophrenia 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

The investigators intend to explore the hypothesis that symptoms of schizophrenia may be reduced by the administration of a probiotic supplement when used in addition to standard antipsychotic medications. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Schizophrenia, Schizoaffective Disorder
What is being tested?: Probiotic Supplement
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 65 participants
Where: 1 siteUnited States
Study dates: Aug 2010to Aug 2012
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.
Primary Axis I diagnosis (DSM-IV) of schizophrenia, any type, OR schizoaffective disorder (APA, 1994).
Currently an outpatient at the time of enrollment.
Residual psychotic symptoms which are at least moderately severe as evidenced by one or more PANSS positive symptom scores, and/or PANSS negative symptom scores of 4 or more; OR a total PANSS score of 50 or more, containing at least three positive or negative items with scores of 3 or more at screening.
Conformance to PORT Treatment Recommendation re Maintenance Antipsychotic Medication Dose (Buchanan et al., 2010).
Receiving antipsychotic medication for at least 8 weeks prior to starting the study with no medication changes within the previous 21 days.
Proficient in the English language.

Who cannot join

Diagnosis of mental retardation.
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 three months.
Participated in any investigational drug trial in the past 30 days.
Pregnant or planning to become pregnant during the study period.

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Receipt of antibiotic medication within the previous 14 days (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, the investigators are not limiting the study to individuals with elevated levels of gliadin or casein antibodies as the investigators intend to look at these levels as a predictor of response.

Trial locations and contacts

1 site in 1 country.

United States1 site

Sheppart Pratt Health System
Towson, Maryland, 21204

Other trials in United States

About this study

Official title: A Double-Blind Placebo-Controlled Trial of a Probiotic Supplement to Reduce the Symptoms of Schizophrenia

Read the detailed description

The primary aim of the current study is:

To evaluate the safety and efficacy of a supplemental probiotic therapy, containing the microorganisms Lactobacillus rhamnosus GG and Bifidobacterium lanimalis subsp. lactis (BB12), for individuals with schizophrenia who have residual psychotic symptoms of at least moderate severity. Secondary aims of the study are:
To assess the effect of probiotic treatment on patients' gastrointestinal functioning
To study the effect of probiotic treatment in lowering the levels of antibodies to casein and gliadin.
To investigate the association between the efficacy of probiotic therapy and initial levels of antibodies to gliadin and casein.

Conditions: Schizophrenia, Schizoaffective Disorder
Being tested: Probiotic Supplement, Identical-appearing Placebo
Keywords: Schizophrenia, Schizoaffective, Probiotic supplements, Gliadin, Casein
Medical subject headings: Schizophrenia, Psychotic Disorders

What participants receive

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

Probiotic SupplementDietary supplement
Probiotic Supplement 1 tablet by mouth daily
Identical-appearing PlaceboDietary supplement
Probiotic identical placebo 1 tablet by mouth daily

Study groups in NCT01242371
Study group	Role	What they receive
Probiotic Supplement	Active comparator	Probiotic supplement 1 tablet by mouth daily for 14 weeks after 2 week placebo run-in Receives: Dietary Supplement: Probiotic Supplement
Identical-appearing Placebo	Placebo comparator	Identical appearing placebo 1 tablet by mouth daily for 14 weeks after 2 week placebo run-in Receives: Dietary Supplement: Identical-appearing Placebo

What is being measured

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

Change in Positive and Negative Syndrome Scale (PANSS) Score From the Start to the End of the Double-blind Treatment Phase (Week 0 to Week 14)
The Positive and Negative Syndrome Scale (PANSS) measures psychiatric symptomatology, especially related to psychosis. The complete PANSS contains ratings for 30 symptoms, including 7 positive symptoms, 7 negative symptoms, and 16 general psychiatric symptoms. The severity of each symptom is rated on a scale ranging from 1 (minimal) to 7 (extreme); higher scores indicate increased symptomatology. Total PANSS scores include scores from all categories and range from 30 to 210 units on a scale.
Measured: 14 weeks (week 0 to week 14)

Secondary outcomes (2)

Gastrointestinal Functioning From the Beginning to the End of the Double-blind Treatment Phase Weeks 0-14
Self report rating of difficulty moving bowels on a 4 point scale from "no difficulty" to "severe difficulty"
Measured: 14 weeks (weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 & 14)
Measurement of Gliadin and Casein Antibody Levels
Measured: 16 weeks (baseline prior to placebo run in to week 14)

Timeline

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

Aug 2010Aug 2012

First posted17 Nov 2010 (estimated)
Study startAug 2010
Primary completionAug 2012
Study completionAug 2012

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 SchizophreniaStudies 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: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01242371
Sponsor's protocol ID: SMRI/SPHS 2010-01
Status last verified: Jan 2019
First submitted: 16 Nov 2010
Last updated: 5 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Dickerson FB, Stallings C, Origoni A, Katsafanas E, Savage CL, Schweinfurth LA, Goga J, Khushalani S, Yolken RH. Effect of probiotic supplementation on schizophrenia symptoms and association with gastrointestinal functioning: a randomized, placebo-controlled trial. Prim Care Companion CNS Disord. 2014;16(1):PCC.13m01579. doi: 10.4088/PCC.13m01579. Epub 2014 Feb 13.
PubMed 24940526

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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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 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 Reduce the Symptoms of Schizophrenia
ClinicalTrials.gov ID: NCT01242371
Acronym / sponsor ID: SMRI/SPHS 2010-01
Conditions: Schizophrenia, Schizoaffective Disorder
Keywords: Schizophrenia, Schizoaffective, Probiotic supplements, Gliadin, Casein
Study type: Interventional
Recruitment status: Completed
Enrolment: 65 participants (actual)
Lead sponsor: Sheppard Pratt Health SystemUniversity, hospital or other
Collaborators: Stanley Medical Research Institute
Study start: Aug 2010
Primary completion: Aug 2012 (actual)
Study completion: Aug 2012 (actual)
First posted: 17 Nov 2010 (estimated)
Results: Posted 14 Nov 2013

Clinical summary

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

Detailed description

The primary aim of the current study is:

To evaluate the safety and efficacy of a supplemental probiotic therapy, containing the microorganisms Lactobacillus rhamnosus GG and Bifidobacterium lanimalis subsp. lactis (BB12), for individuals with schizophrenia who have residual psychotic symptoms of at least moderate severity. Secondary aims of the study are:
To assess the effect of probiotic treatment on patients' gastrointestinal functioning
To study the effect of probiotic treatment in lowering the levels of antibodies to casein and gliadin.
To investigate the association between the efficacy of probiotic therapy and initial levels of antibodies to gliadin and casein.

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	Active comparator	Dietary Supplement: Probiotic SupplementProbiotic supplement 1 tablet by mouth daily for 14 weeks after 2 week placebo run-in
Identical-appearing Placebo	Placebo comparator	Dietary Supplement: Identical-appearing PlaceboIdentical appearing placebo 1 tablet by mouth daily for 14 weeks after 2 week placebo run-in

Who may qualify

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

Key inclusion criteria (8 listed)

Age 18-65.
Capacity for written informed consent.
Primary Axis I diagnosis (DSM-IV) of schizophrenia, any type, OR schizoaffective disorder (APA, 1994).
Currently an outpatient at the time of enrollment.
Residual psychotic symptoms which are at least moderately severe as evidenced by one or more PANSS positive symptom scores, and/or PANSS negative symptom scores of 4 or more; OR a total PANSS score of 50 or more, containing at least three positive or negative items with scores of 3 or more at screening.

Key exclusion criteria (9 listed)

Diagnosis of mental retardation.
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 three months.
Participated in any investigational drug trial in the past 30 days.

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 SupplementProbiotic Supplement 1 tablet by mouth daily	Dietary supplement	Probiotic Supplement
Identical-appearing PlaceboProbiotic identical placebo 1 tablet by mouth daily	Dietary supplement	Identical-appearing Placebo

Primary outcome

Change in Positive and Negative Syndrome Scale (PANSS) Score From the Start to the End of the Double-blind Treatment Phase (Week 0 to Week 14)
Time frame: 14 weeks (week 0 to week 14)
The Positive and Negative Syndrome Scale (PANSS) measures psychiatric symptomatology, especially related to psychosis. The complete PANSS contains ratings for 30 symptoms, including 7 positive symptoms, 7 negative symptoms, and 16 general psychiatric symptoms. The severity of each symptom is rated on a scale ranging from 1 (minimal) to 7 (extreme); higher scores indicate increased symptomatology. Total PANSS scores include scores from all categories and range from 30 to 210 units on a scale.

2 secondary outcomes

Gastrointestinal Functioning From the Beginning to the End of the Double-blind Treatment Phase Weeks 0-14
Time frame: 14 weeks (weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 & 14)
Measurement of Gliadin and Casein Antibody Levels
Time frame: 16 weeks (baseline prior to placebo run in to week 14)

Results and safety

Results posted to the registry on 14 Nov 2013, 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	31
Identical-appearing Placebo	32	27

Primary outcome: Change in Positive and Negative Syndrome Scale (PANSS) Score From the Start to the End of the Double-blind Treatment Phase (Week 0 to Week 14)

Time frame: 14 weeks (week 0 to week 14). Mean (Standard Deviation). Unit: units on a scale

Measure	Probiotic Supplement n = 33	Identical-appearing Placebo n = 32
Wk 0 (Begin Treatment) PANSS Total Score, n=33,32	67.55 (11.64)	69.56 (11.73)
Wk 14 (End Treatment) PANSS Total Score, n=31,27	67.42 (11.66)	67.69 (11.86)

Population analysed: Week 0 data is based on the number of participants in the probiotic supplement group (n=33) and the placebo group (n=32) who began the treatment phase. Week 14 data is based on the number of participants in the probiotics supplement group (n=31) and the placebo group (n=27) who completed the treatment phase.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected over a 16 week period, including the 2 week placebo run in and the 14 week double-blind treatment phase.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Probiotic Supplement	2 of 33 (6.1%)	19 of 33 (57.6%)	Not reported
Identical-appearing Placebo	1 of 32 (3.1%)	21 of 32 (65.6%)	Not reported

Limitations and caveats (from the sponsor): Did not perform more detailed measures of gastrointestinal functioning or obtain a more complete history of participants' gastrointestinal symptoms and associated treatment

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24940526Dickerson FB, Stallings C, Origoni A, Katsafanas E, Savage CL, Schweinfurth LA, Goga J, Khushalani S, Yolken RH. Effect of probiotic supplementation on schizophrenia symptoms and association with gastrointestinal functioning: a randomized, placebo-controlled trial. Prim Care Companion CNS Disord. 2014;16(1):PCC.13m01579. doi: 10.4088/PCC.13m01579. Epub 2014 Feb 13.

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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 B 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 in people with Schizophrenia 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 8 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 5 Feb 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 14 Nov 2013). 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?

Change in Positive and Negative Syndrome Scale (PANSS) Score From the Start to the End of the Double-blind Treatment Phase (Week 0 to Week 14) (time frame: 14 weeks (week 0 to week 14)). 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 NCT01242371, 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 5 Feb 2019.