Synbiotic Compound to Reduce Symptoms of Schizophrenia
A Double-Blind Placebo-Controlled Trial of the Synbiotic Compound Probio-Tec ABCG for Schizophrenia Patients With and Without Elevated Markers of Gastrointestinal Inflammation
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 65 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether a synbiotic supplement can reduce schizophrenia symptoms when added to usual antipsychotic medicines. It compares the supplement with a placebo, which has no active treatment. The study is for adults ages 18–65 with schizophrenia or schizoaffective disorder who still have symptoms.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are 18–65 years old.
- You can understand the study and give written consent to join.
- A study interview confirms schizophrenia or schizoaffective disorder, which includes symptoms of schizophrenia and mood problems.
- You are not staying in a hospital for care when you join.
- You still have at least moderate symptoms and meet the required scores on the study’s symptom test.
- You have taken antipsychotic medicine for at least 8 weeks, with no changes in the past 21 days.
- You are skilled in using English.
Who can't join
- You have an intellectual disability, which affects learning and everyday skills.
- The study team finds you have a serious or unstable illness, such as heart failure, liver disease, kidney failure, or cancer under treatment. Certain immune system problems, such as HIV, or treatment with chemotherapy or certain medicines for autoimmune disease also exclude you.
- You have ever injected drugs into a vein.
- You had a moderate or severe substance use disorder in the past 3 months, other than caffeine or tobacco use. A positive drug test will need further review by the study doctor.
- You took part in a study of an experimental drug in the past 30 days.
- You are pregnant or plan to become pregnant during the study.
- You took antibiotics within 14 days before visit 2, or regularly used probiotic or prebiotic supplements in the past 2 weeks. These supplements support gut bacteria. You may be checked again for eligibility later.
- You have inflammatory bowel disease, such as Crohn’s disease or ulcerative colitis, or celiac disease, an illness caused by a reaction to gluten.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion 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. Exclusion Criteria: * 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
Study sites (1)
MD
- Sheppard Pratt Health System · Batlimore, MD 21285Emily Katsafanas · Study contact · 443-608-3300 · ekatsafanas@sheppardpratt.orgMore trials in Batlimore