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NCT01558557 · ClinicalTrials.gov registry record · NA
Gluten Free Diet in People With Schizophrenia: A Pilot Study
A NA study, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- NA
- Development phase
- 3
- Enrollment target
NCT01558557: Completed NA study, sponsored by University of Maryland, Baltimore.
NCT01558557 is a NA study that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 3 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01558557, a NA study, has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- NA
- Development phase
- 3 participants
- Enrollment target
Study 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 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
Interventions
- OTHER Gluten Free Diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2008-06 |
| Est. Completion | 2014-01 |
| Phase | NA |
What the finished NCT01558557 record still lists
NCT01558557 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Gluten Free Diet is the first listed.
NCT01558557 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01558557 about?
NCT01558557 is a clinical study titled "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 ...
What is the current status of trial NCT01558557?
This trial is currently completed. It is a NA study. The enrollment target is 3 participants. The study started on 2008-06. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01558557?
The interventions under investigation include: Gluten Free Diet (OTHER).
Who is sponsoring clinical trial NCT01558557?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01558557's enrollment target sits among peer trials
3 1996th of 2000 higher than 4 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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