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Gluten-Free Diet for Schizophrenia

N/A
Recruiting
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
Same antipsychotic for at least 4 weeks
Age 18- 64 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 weeks
Awards & highlights

Study Summary

This trial will test whether a gluten-free diet can improve symptoms in people with schizophrenia who have AGA antibodies. Outcomes will include cognitive symptoms, changes in inflammation, and gut/blood brain barrier permeability.

Who is the study for?
This trial is for adults aged 18-64 with schizophrenia or schizoaffective disorder who have high levels of anti-gliadin antibodies and significant negative symptoms. They must be stable on their current antipsychotic medication and able to consent to the study. People already on gluten-free diets, pregnant women, those with Celiac Disease or gluten ataxia are excluded.Check my eligibility
What is being tested?
The trial tests if a strict gluten-free diet can improve negative symptoms in participants compared to a control group consuming gluten. It's a double-blind study, meaning neither the researchers nor participants know who gets which diet. Effects on cognition, inflammation, and gut/brain barrier are also studied.See study design
What are the potential side effects?
Since this trial involves dietary changes rather than medication, side effects may include digestive discomfort or allergic reactions related to the protein shakes' ingredients (gluten flour or rice flour).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been on the same antipsychotic medication for at least 4 weeks.
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I am between 18 and 64 years old.
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I have been diagnosed with schizophrenia or schizoaffective disorder.
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I scored 10 or higher on a test to show I can understand consent.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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
Negative symptom change as defined by difference in Scale for the Assessment of Negative Symptoms (SANS) score
Secondary outcome measures
Change in cognitive function as measured by change in MATRICS Consensus Cognitive Battery (MCCB)

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: GlutenActive Control1 Intervention
30 grams of gluten flour daily in protein shake
Group II: PlaceboPlacebo Group1 Intervention
30 grams of rice flour daily in protein shake

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
688 Previous Clinical Trials
374,616 Total Patients Enrolled
66 Trials studying Schizophrenia
10,217 Patients Enrolled for Schizophrenia

Media Library

Gluten-Free Diet (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03183609 — N/A
Schizophrenia Research Study Groups: Placebo, Gluten
Schizophrenia Clinical Trial 2023: Gluten-Free Diet Highlights & Side Effects. Trial Name: NCT03183609 — N/A
Gluten-Free Diet (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03183609 — N/A

Frequently Asked Questions

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

Are the elderly being considered for inclusion in this research effort?

"This medical trial is accepting participants in the 18 to 64 year old age range. Separately, 108 clinical trials are available for minors and 246 studies are available for individuals over 65."

Answered by AI

What is the current enrollment count for this medical investigation?

"Affirmative. The information on clinicaltrials.gov exemplifies that the medical trial is actively recruiting participants, with its inception date being July 10th 2017 and most recent update October 26th 2022. A total of 40 patients are in need of recruitment from one specified site."

Answered by AI

To what demographic does this clinical trial cater?

"The trial is open to 40 patients with schizophrenia, aged between 18 and 64. Necessary criteria include an aptitude for consent (determined by a score of 10 or greater on the Evaluation to Sign Consent test), SANS total score ≥20, and affective flattening/alogia global item ≥3."

Answered by AI

Are participants still being enrolled for this research study?

"Affirmative. The information hosted on clinicaltrials.gov conveys that this medical investigation, which was initially posted on July 10th 2017, is now recruiting participants. Approximately 40 patients must be enrolled from a single site."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
What site did they apply to?
Maryland Psychiatric Research Center (MPRC) Outpatient Research Program (ORP); the MPRC Treatment Research Program (TRP)
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Recent research and studies
clinicaltrials.govStudy
Confirmatory Efficacy Trial of a Gluten-Free Diet in a Subgroup of Persons With Schizophrenia Who Have High Levels of IgG Anti-Gliadin Antibodies (AGA IG)
Deanna Kelly 2017. "Confirmatory Efficacy Trial of a Gluten-Free Diet in a Subgroup of Persons With Schizophrenia Who Have High Levels of IgG Anti-Gliadin Antibodies (AGA IG)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03183609.
All > Schizophrenia
~5 spots leftby Apr 2025
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