UMIN-CTR Clinical Trial

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
Email	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
Email	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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
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
Registered date	File name

Research case data
Registered date	File name

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