RECRUITING

Synbiotic Compound to Reduce Symptoms of Schizophrenia

Conditions

Schizophrenia Schizoaffective Disorder Synbiotics Synbiotic

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to determine if taking a synbiotic supplement versus a placebo will reduce symptoms of schizophrenia when used in addition to standard antipsychotic medications.

Official Title

A Double-Blind Placebo-Controlled Trial of the Synbiotic Compound Probio-Tec ABCG for Schizophrenia Patients With and Without Elevated Markers of Gastrointestinal Inflammation

Quick Facts

Study Start:2022-02-21

Study Completion:2025-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04226898

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age 18-65, inclusive. * Capacity for written informed consent. * Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnosis of schizophrenia or schizoaffective disorder (APA 2013) as determined by the Structured Clinical Interview for DSM-5 Disorders (SCID-5). * Outpatient at the time of enrollment. * Residual psychotic symptoms of at least moderate severity as evidenced by a Positive and Negative Syndrome Scale (Kay et al., 1987) (PANSS) total score of 60 or higher AND one or more of the following: one or more PANSS positive symptom scores of 4 or higher; OR containing at least three positive or negative items with scores of 3 or higher at the screening visit. * 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.	* DSM-5 diagnosis of intellectual disability or comparable diagnosis determined by previous versions of the DSM. * Any clinically significant or unstable medical disorder as determined by the investigators, including congestive heart failure, liver disease, renal failure, any diagnosis of cancer undergoing active treatment. * A primary immunodeficiency condition such as HIV infection, or undergoing cancer chemotherapy, or receiving systemic corticosteroids, methotrexate or monoclonal antibodies for treatment of an autoimmune disorder. * History of IV drug use. * DSM-5 diagnosis of a moderate or severe substance use disorder, except for caffeine or tobacco, within the last three months prior to the screening visit. If the patient has a positive drug toxicity screen at the time of visit 1 (screening) further evaluation by the investigator will be done of the substance use to determine eligibility. * 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 14 days prior to visit 2 (as anaerobic organisms residing in the gastrointestinal tract may be minimally affected by antibiotics). Of note, patients on antibiotic may be re-screened once the minimum duration of time since antibiotics use has been met. * Current and regular use of a probiotic and or prebiotic supplement within the past 2 weeks. Of note, patients taking prebiotic or probiotic supplements may be re-screened. * Documented inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis) or celiac disease

Inclusion Criteria

Exclusion Criteria

* Age 18-65, inclusive.
* Capacity for written informed consent.
* Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnosis of schizophrenia or schizoaffective disorder (APA 2013) as determined by the Structured Clinical Interview for DSM-5 Disorders (SCID-5).
* Outpatient at the time of enrollment.
* Residual psychotic symptoms of at least moderate severity as evidenced by a Positive and Negative Syndrome Scale (Kay et al., 1987) (PANSS) total score of 60 or higher AND one or more of the following: one or more PANSS positive symptom scores of 4 or higher; OR containing at least three positive or negative items with scores of 3 or higher at the screening visit.
* 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.

* DSM-5 diagnosis of intellectual disability or comparable diagnosis determined by previous versions of the DSM.
* Any clinically significant or unstable medical disorder as determined by the investigators, including congestive heart failure, liver disease, renal failure, any diagnosis of cancer undergoing active treatment.
* A primary immunodeficiency condition such as HIV infection, or undergoing cancer chemotherapy, or receiving systemic corticosteroids, methotrexate or monoclonal antibodies for treatment of an autoimmune disorder.
* History of IV drug use.
* DSM-5 diagnosis of a moderate or severe substance use disorder, except for caffeine or tobacco, within the last three months prior to the screening visit. If the patient has a positive drug toxicity screen at the time of visit 1 (screening) further evaluation by the investigator will be done of the substance use to determine eligibility.
* 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 14 days prior to visit 2 (as anaerobic organisms residing in the gastrointestinal tract may be minimally affected by antibiotics). Of note, patients on antibiotic may be re-screened once the minimum duration of time since antibiotics use has been met.
* Current and regular use of a probiotic and or prebiotic supplement within the past 2 weeks. Of note, patients taking prebiotic or probiotic supplements may be re-screened.
* Documented inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis) or celiac disease

Contacts and Locations

Study Contact

Emily Katsafanas

CONTACT

410-938-4360

ekatsafanas@sheppardpratt.org

Principal Investigator

Faith Dickerson, PhD, MPH

PRINCIPAL_INVESTIGATOR

Sheppard Pratt Health System

Study Locations (Sites)

Sheppard Pratt Health System

Baltimore, Maryland, 21285

United States

Collaborators and Investigators

Sponsor: Sheppard Pratt Health System

Faith Dickerson, PhD, MPH, PRINCIPAL_INVESTIGATOR, Sheppard Pratt Health System

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-21

Study Completion Date2025-01

Study Record Updates

Study Start Date2022-02-21

Study Completion Date2025-01

Terms related to this study

Keywords Provided by Researchers

Schizophrenia
Schizoaffective Disorder
Synbiotics
Synbiotic

Additional Relevant MeSH Terms

Schizophrenia
Schizoaffective Disorder