Gluten SensitivityNCT01558557
Gluten Free Diet in People With Schizophrenia: A Pilot Study
A study testing Gluten Free Diet in people with Gluten Sensitivity and Celiac Disease, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Gluten Sensitivity, Celiac Disease
- What is being tested?
- Gluten Free Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects will be of either gender and of any race, with an age range of 18 55.
- Subjects will meet DSM-IV (APA, 1994) criteria for either schizophrenia or schizoaffective disorder. A best estimate diagnostic approach will be utilized in which information from the Structured Clinical Interview for DSM-IV (First et al, 1997) is supplemented by information from family informants, previous psychiatrists, and medical records to generate a diagnosis.
- Subjects will be required to have celiac disease (positive tTG antibody) or have gluten sensitivity (positive or AGA antibodies).
- Must be clinically stable and on the same antipsychotic for at least two months with an unchanged dose for the prior four weeks.
- Participants must complete the Evaluation to Sign Consent with a score of 10/12 or higher.
Who cannot join
- Pregnant or lactating women will be excluded. Pregnancy will be determined by pregnancy test. Lactating will be determined by participant report.
Trial locations and contacts
1 site in 1 country.
United States1 site
Maryland Psychiatric Research Center
Catonsville, Maryland, 21228
About this 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;
- Celiac disease (positive tTG antibody); and
- Positive assay on Antigliadin antibodies
- Conditions
- Gluten Sensitivity, Celiac Disease
- Being tested
- Gluten Free Diet
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gluten Free DietOther
Participants will be given a Gluten Free Diet for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Gluten Free Diet | Experimental | Not described Receives: Other: Gluten Free Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in symptoms from baseline to end of study
Measured: Baseline and 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2012 (estimated)
- Study startJun 2008
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gluten SensitivityStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MPRC, University of Maryland, Baltimore
- Investigators
- Deanna L Kelly, Pharm.D., BCPP, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01558557
- Sponsor's protocol ID
- HP-00041292
- Status last verified
- Sep 2019
- First submitted
- 15 Mar 2012
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gluten Free Diet in People With Schizophrenia: A Pilot Study
- ClinicalTrials.gov ID
- NCT01558557
- Acronym / sponsor ID
- HP-00041292
- Conditions
- Gluten Sensitivity, Celiac Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 20 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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;
- Celiac disease (positive tTG antibody); and
- Positive assay on Antigliadin antibodies
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gluten Free Diet | Experimental | Other: Gluten Free Diet |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects will be of either gender and of any race, with an age range of 18 55.
- Subjects will meet DSM-IV (APA, 1994) criteria for either schizophrenia or schizoaffective disorder. A best estimate diagnostic approach will be utilized in which information from the Structured Clinical Interview for DSM-IV (First et al, 1997) is supplemented by information from family informants, previous psychiatrists, and medical records to generate a diagnosis.
- Subjects will be required to have celiac disease (positive tTG antibody) or have gluten sensitivity (positive or AGA antibodies).
- Must be clinically stable and on the same antipsychotic for at least two months with an unchanged dose for the prior four weeks.
- Participants must complete the Evaluation to Sign Consent with a score of 10/12 or higher.
Key exclusion criteria (1 listed)
- Pregnant or lactating women will be excluded. Pregnancy will be determined by pregnancy test. Lactating will be determined by participant report.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gluten Free DietParticipants will be given a Gluten Free Diet for 2 weeks | Other | Gluten Free Diet |
Primary outcome
Change in symptoms from baseline to end of study
Time frame: Baseline and 2 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
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Single-cell Immune Response to Controlled Gluten Ingestion in Pediatric Celiac Disease
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Dietary Approach to Mild-to-moderate Psoriasis
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Tolerability of an Ancient Grain in Patients With Non-Celiac Wheat Sensitivity
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deanna L Kelly, Pharm.D., BCPP principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gluten Free Diet in people with Gluten Sensitivity and Celiac Disease, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in symptoms from baseline to end of study (time frame: Baseline and 2 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2019; AzTrials last refreshed its copy on 6 Nov 2026.