UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024074 |
|---|---|
| Receipt number | 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 18:06:47 |
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Basic information
Public title
Gluten sensitivity among the patients with schizophrenia and the possibility of therapeutic effect of gluten free diet
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
Scientific Title:Acronym
Gluten sensitivity and therapeutic effect of gluten free diet for schizophrenia
Region
| Japan |
Condition
Condition
schizophrenia
Classification by specialty
| Psychiatry |
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
| Food |
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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
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
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
Target sample size
280
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yamada Hisashi |
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
| 1st name | |
| Middle name | |
| Last name | yamada hisashi |
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 or person
Institute
hyogo medical college
department of psychiatry
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 04 | Day |
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.
Results date posted
| 2019 | Year | 03 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 10 | Month | 04 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 04 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 15 | Day |
Last modified on
| 2020 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027697
