Ignite Creation Date:
2024-05-06 @ 12:21 AM
Last Modification Date:
2024-10-26 @ 10:48 AM
Study NCT ID:
NCT01558557
Status:
COMPLETED
Last Update Posted:
2019-09-27
First Post:
2012-03-15
Brief Title:
Gluten Free Diet in People With Schizophrenia A Pilot Study
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Gluten Free Diet in People With Schizophrenia A Pilot Study
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 55 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 11 of the comparison sample An unexpected finding was that 234 age adjusted of the CATIE sample had antibodies to gliadin compared to 29 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 N4 or positive assays for anti-gliadin antibodies N4 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
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 N4 or positive assays for anti-gliadin antibodies N4 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None