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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
Awards & highlights

FOCIS Trial 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.Check my eligibility
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.See study design
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.

FOCIS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in serum butyrate levels
Cognition
Incidence of Side Effects
Secondary outcome measures
Change in Affective Symptoms
Change in Negative Symptoms
Change in Positive Symptoms
+2 more

FOCIS Trial 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
832 Previous Clinical Trials
668,873 Total Patients Enrolled
University of Maryland, BaltimoreLead Sponsor
688 Previous Clinical Trials
374,596 Total Patients Enrolled
Robert Buchanan, M.D.Principal InvestigatorUniversity of Maryland, Baltimore

Media Library

Placebo Prebiotic (Placebo) Clinical Trial Eligibility Overview. Trial Name: NCT05527210 — N/A
Schizoaffective Disorder Research Study Groups: Placebo, Active Study Med
Schizoaffective Disorder Clinical Trial 2023: Placebo Prebiotic Highlights & Side Effects. Trial Name: NCT05527210 — N/A
Placebo Prebiotic (Placebo) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05527210 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research accommodate participants aged 20 or above?

"This trial is welcoming participants of legal age (18+) and below the senior threshold (60-)."

Answered by AI

What is the primary objective of this medical experiment?

"This 12-week trial primarily seeks to measure alterations in serum butyrate levels. Other secondary objectives include changes in affective symptoms (CDS), negative symptoms (SANS) and effects of gut composition, such as cytokine concentration, permeability of the intestinal wall and microbiota composition."

Answered by AI

Are there any vacancies remaining in this clinical research?

"Data on clinicaltrials.gov reveals that, at this time, the trial is not actively searching for participants as it was last updated in September of 2022. However, 437 other studies are currently enrolling patients."

Answered by AI

Is eligibility for this research project open to me?

"This clinical trial is taking on 60 people with a diagnosis of schizophrenia or schizoaffective disorder between 18 and 60 years old. Crucially, the following criteria must be met: DSM-5 diagnostic confirmation; age range from 18 to 60; BMI not exceeding 40; ongoing antipsychotic treatment for 14 days prior to enrolment; and evaluation at 10/10 or above on the Evaluation to Sign Consent measure."

Answered by AI

Who else is applying?

What state do they live in?
Texas
New Jersey
What site did they apply to?
Maryland Psyciatric Research Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Phone Call
Most responsive sites:
  1. Maryland Psyciatric Research Center: < 48 hours
Recent research and studies
clinicaltrials.govStudy
Prebiotic Treatment in People With Schizophrenia
Robert Buchanan 2023. "Prebiotic Treatment in People With Schizophrenia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05527210.
All > Schizophrenia
~34 spots leftby Jan 2026
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