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Synbiotic Therapy for Schizophrenia
Phase 2
Recruiting
Led By Faith Dickerson, PhD, MPH
Research Sponsored by Sheppard Pratt Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Residual psychotic symptoms of at least moderate severity as evidenced by a Positive and Negative Syndrome Scale (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
Outpatient at the time of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 weeks (week 0 to week 14)
Awards & highlights
Study Summary
This trial will compare the effects of a synbiotic supplement versus a placebo on symptoms of schizophrenia when used in addition to standard antipsychotic medications.
Who is the study for?
Adults aged 18-65 with schizophrenia or schizoaffective disorder, experiencing moderate symptoms despite antipsychotic medication, can join. They must understand English and give informed consent. Excluded are those with intellectual disabilities, recent substance abuse (except caffeine/tobacco), pregnancy plans, antibiotic use within two weeks, immune deficiencies, IV drug history, certain digestive diseases or unstable medical conditions.Check my eligibility
What is being tested?
The trial is testing if a synbiotic supplement can reduce schizophrenia symptoms alongside standard medications compared to an inert placebo. Participants will be randomly assigned to receive either the synbiotic compound or placebo.See study design
What are the potential side effects?
Potential side effects of the synbiotic supplement may include digestive discomfort such as bloating or gas due to changes in gut bacteria but specific side effect profiles will be monitored throughout the study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have moderate to severe psychotic symptoms.
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I am not hospitalized and can visit the clinic for treatments.
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I am between 18 and 65 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 weeks (week 0 to week 14)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 weeks (week 0 to week 14)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Positive and Negative Syndrome Scale (PANSS) Score From the Start to the End of the Double-blind Treatment Phase
Secondary outcome measures
Placebos
Intestinal Inflammation Markers (#1) Antibodies to Saccharomyces cerevisiae
Intestinal Inflammation Markers (#2) Antibodies to Gliadin
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Synbiotic SupplementExperimental Treatment1 Intervention
The active synbiotic supplement consists of a stick/packet containing 4 strains of probiotic microorganisms: Lactobacillus acidophilus, LA-5® (material number 501082 FD LAK KGPharma); Lactobacillis paracasei subsp. paracasei, L. CASEI 431® (material number 684301 FD L. casei 431 HA Granulate); Lactobacillus rhamnosus, LGG® (material number 699817 FD LGG HA-W-IF); and Bifidobacterium animalis subsp. lactis, BB-12® (material number 699813 FD BB-12 HA-W-IF). In addition, the stick/sachet contains 5 g inulin. The product is a powder which participants will be asked to take with liquid or food. In this arm, the participant will take 1 powder stick of the synbiotic supplement once a day for 12 weeks after a 2-week placebo run-in.
Group II: Inert CompoundPlacebo Group1 Intervention
The inert compound placebo looks identical to the synbiotic supplement. In this arm, the participant will take 1 powder stick of the placebo daily for 12 weeks after a 2 week placebo run-in.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Synbiotic Supplement
2016
N/A
~100
Find a Location
Who is running the clinical trial?
Sheppard Pratt Health SystemLead Sponsor
21 Previous Clinical Trials
7,741 Total Patients Enrolled
6 Trials studying Schizophrenia
368 Patients Enrolled for Schizophrenia
Faith Dickerson, PhD, MPHPrincipal InvestigatorSheppard Pratt Health System
3 Previous Clinical Trials
210 Total Patients Enrolled
1 Trials studying Schizophrenia
64 Patients Enrolled for Schizophrenia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been on the same antipsychotic medication for at least 8 weeks without changes.I have a weakened immune system due to HIV, cancer treatment, or medication for autoimmune disorders.I do not have any serious or unstable health conditions.I can understand and sign the consent form.I have moderate to severe psychotic symptoms.I haven't taken antibiotics in the last 14 days.I am not hospitalized and can visit the clinic for treatments.I have been regularly taking probiotic or prebiotic supplements for the last 2 weeks.You have used drugs by injecting them directly into your veins in the past.I have been diagnosed with Crohn's, ulcerative colitis, or celiac disease.I am between 18 and 65 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Synbiotic Supplement
- Group 2: Inert Compound
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are elderly individuals being admitted into this control group?
"The age restriction for this particular trial is between 18-65 years old. However, there are other options available: 95 clinical trials for those under 18 and 219 trials for patients 65 and over."
Answered by AI
Can people with the specified medical condition enroll in this trial at this time?
"The clinicaltrials.gov website reveals that this study is not currently looking for new participants. Although the last update to this posting was on March 14th, 2022, there are 450 other medical trials actively recruiting patients."
Answered by AI
What are some possible dangers associated with taking Synbiotic Supplement?
"Synbiotic Supplement currently sits at a 2 on our safety scale at Power. This is due to the fact that, while Phase 2 trials have yielded some promising safety data, there is a lack of evidence when it comes to efficacy."
Answered by AI
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