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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000024074 |
Receipt No. | R000027697 |
Scientific Title | Gluten sensitivity among the patients with schizophrenia and the possibility of therapeutic effect of gluten free diet |
Date of disclosure of the study information | 2016/10/04 |
Last modified on | 2020/03/23 |
Basic information | ||
Public title | Gluten sensitivity among the patients with schizophrenia and the possibility of therapeutic effect of gluten free diet
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Acronym | Gluten sensitivity and therapeutic effect of gluten free diet for schizophrenia | |
Scientific Title | Gluten sensitivity among the patients with schizophrenia and the possibility of therapeutic effect of gluten free diet
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Scientific Title:Acronym | Gluten sensitivity and therapeutic effect of gluten free diet for schizophrenia | |
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Condition | ||
Condition | schizophrenia | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To clarify the gluten sensitivity and its relationships between symptoms , severity, and drugs responsibility among the patients with schizophrenia in Japan and effectiveness of gluten free diet for the schizophrenia patients with gluten sensitivity. |
Basic objectives2 | Others |
Basic objectives -Others | To measure the antibody related to gluten sensitivity with the plasma obtained from the patients with schizophrenia.
To investigate the effectiveness of gluten free diet for the schizophrenia patients with gluten sensitivity, open trail with gluten free diet for two weeks is performed |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Others |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | Assessment of gluten sensitivity is determined by the titer of tissue transglutaminase IgA antibody, the deamidated gliadin peptide IgA antibody, gliadin IgA antibody, gliadin IgGa nti body.
The effectiveness of gluten free diet is assessed by PANSS before and two weeks later of taking gluten free diet. Improved patients is assessed at four and eight weeks. |
Key secondary outcomes | The comparison between gluten sensitivity group and gluten negative group is performed by PANSS, GAF, SOFAS, QOL-26.
The effectiveness of gluten free diet is assessed by CGI-I |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | NO |
Dynamic allocation | NO |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | gluten sensitive patients with schizophrenia have gluten free diet for two weeks. Patients whose symptoms are improved (PANSS score decrease twenty percents or CGI-I score above three at two weeks) continue gluten free diet for eight weeks.
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | patient who met the criteria of schizophrenia in the DSM-5
patient who can understand the purpose of this study and be approved to participate by doctor patient who can provide written informed consent |
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Key exclusion criteria | patient with remarkable excitement, violent action, self-injurious behavior
patient with social behavior patinet who can't provide written informed consent patient who have substance abuse or dependent |
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Target sample size | 280 |
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Name of lead principal investigator |
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Organization | hyogo medical college | ||||||
Division name | department of psychiatry | ||||||
Zip code | |||||||
Address | 1-1, mukogawatyo, nisinomiya city, hyogo | ||||||
TEL | 0798-45-6051 | ||||||
hisa0820@hyo-med.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | hyogo medical college | ||||||
Division name | department of psychiatry | ||||||
Zip code | |||||||
Address | 1-1, mukogawatyo, nisinomiya city, hyogo | ||||||
TEL | 0798-45-6051 | ||||||
Homepage URL | |||||||
hisa0820@hyo-med.ac.jp |
Sponsor | |
Institute | hyogo medical college
department of psychiatry |
Institute | |
Department |
Funding Source | |
Organization | Hyogo College of Medicine |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | Mihara hospital |
Name of secondary funder(s) |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
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Institutions |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Partially published |
Result | |||||||
URL related to results and publications | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5474459/ | ||||||
Number of participants that the trial has enrolled | |||||||
Results | There was no significant difference in gluten sensitivity between groups schizophrenia and controls. AG-IgG plasma concentration was significantly higher in patients with schizophrenia than in controls. Treatment-resistant patients in gluten sensitivity were significantly much more than those in non-gluten sensitivity. We found that AG-IgG concentration in treatment-resistant patients is significantly higher than that in non-treatment-resistant patients. | ||||||
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Recruitment status | Completed | ||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027697 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
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Research case data | |
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