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Placebo
Prebiotics for Schizophrenia (FOCIS Trial)
N/A
Recruiting
Led By Robert Buchanan, M.D.
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Summary
This trial will test whether an anti-inflammatory drug can help improve symptoms in people with schizophrenia.
Who is the study for?
Adults aged 18-60 with a stable condition of schizophrenia or schizoaffective disorder, not on recent immune therapy or prebiotic treatment, and without severe brain injury, gastrointestinal disorders, substance misuse (except mild marijuana use), intellectual disability, pregnancy, or acute antibiotic use.
What is being tested?
The trial is testing the effects of a prebiotic supplement versus a placebo in people with schizophrenia. The goal is to see if the prebiotic can reduce inflammation and improve cognitive impairments associated with the illness.
What are the potential side effects?
While specific side effects are not listed for this trial, common side effects from prebiotics may include bloating, gas, discomfort in the digestive system or allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in serum butyrate levels
Cognition
Incidence of Side Effects
Secondary study objectives
Change in Affective Symptoms
Change in Negative Symptoms
Change in Positive Symptoms
+2 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Active Study MedActive Control1 Intervention
Participants randomized to active study medication will mix 4g of powder prebiotic with water, 3 times a day for 12 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Participants randomized to active study medication will mix 4g of powder placebo with water, 3 times a day for 12 weeks.
Find a Location
Who is running the clinical trial?
National Center for Complementary and Integrative Health (NCCIH)NIH
858 Previous Clinical Trials
672,258 Total Patients Enrolled
University of Maryland, BaltimoreLead Sponsor
713 Previous Clinical Trials
379,432 Total Patients Enrolled
Robert Buchanan, M.D.Principal InvestigatorUniversity of Maryland, Baltimore
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 60 years old.I am on a stable dose of antipsychotic medication for the past 14 days.I am currently taking antibiotics.I have not had a significant brain injury or disorder.I am unable to follow the study's required procedures.I have been diagnosed with schizophrenia or schizoaffective disorder.I haven't had immune therapy in the last 3 months.I have been diagnosed with schizophrenia or schizoaffective disorder.I have a GI disorder that could affect my schizophrenia treatment.I have not taken prebiotics or probiotics in the last three months.I understand the consent process, scoring over 10 on the evaluation.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Active Study Med
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.
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