Celiac Disease Clinical Trial
Official title:
Gluten Free Diet in People With Schizophrenia: A Pilot Study
Background: Celiac disease is an immune-mediated reaction to gluten, presenting with
diarrhea, weight loss, abdominal complaints and a range of less common associated neurologic
and psychiatric symptoms. Evidence of a link between schizophrenia and celiac disease dates
back to 1961. Recent evidence shows that 5.5% (age adjusted) of persons with schizophrenia
participating in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE)
study had a level of antibodies to tTG that is consistent with a diagnosis of celiac disease
(compared to 1.1% of the comparison sample). An unexpected finding was that 23.4% (age
adjusted) of the CATIE sample had antibodies to gliadin (compared to 2.9% of the comparison
sample). It is hypothesized that a gluten free diet in people with schizophrenia who have
Celiac disease or gluten sensitivity will have improvement in symptoms and quality of life.
Objectives: The aim of this proposed pilot study is to establish the feasibility of a
initiating and maintaining a Gluten-free diet in these two groups. For this study The
investigators will identify 8 individuals who have positive assays to tTG antibodies and
confirmed celiac disease (N=4), or positive assays for anti-gliadin antibodies (N=4). The
investigators plan to consent at least 2 subjects from each group and ask them to participate
in a two-week open label treatment of a gluten free diet. The groups are;
1. Celiac disease (positive tTG antibody); and
2. Positive assay on Antigliadin antibodies
n/a
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