UMIN-CTR Clinical Trial

Basic information
Public title	Specialty outpatients care for gluten sensitivity of Hyogo College of Medicine and therapeutic effects of gluten-free diet.
Acronym	Specialty outpatients care for gluten sensitivity of Hyogo College of Medicine and therapeutic effects of gluten-free diet.
Scientific Title	Specialty outpatients care for gluten sensitivity of Hyogo College of Medicine and therapeutic effects of gluten-free diet.
Scientific Title:Acronym	Specialty outpatients care for gluten sensitivity of Hyogo College of Medicine and therapeutic effects of gluten-free diet.
Region	Japan

Condition
Condition	all disease
Classification by specialty	Medicine in general Psychiatry Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the gluten sensitivity and its relationships between pshysical and mental disease among the outpatients with specialty outpatients care for gluten sensitivity of Hyogo College of Medicine and effectiveness of gluten free diet for the depression patients with gluten sensitivity.
Basic objectives2	Others
Basic objectives -Others	To measure the antibody related to gluten sensitivity with the plasma obtained from the outpatients with specialty outpatients care for gluten sensitivity of Hyogo College of Medicine. To investigate the effectiveness of gluten free diet for the depression patients with gluten sensitivity, open trail with gluten free diet for two weeks is performed.
Trial characteristics_1
Trial characteristics_2
Developmental phase

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.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Administer a gluten-free diet to gluten-sensitive patients for 2 weeks and observe improvement in symptoms. If the subjective symptoms improve, continue a gluten-free diet for another 2 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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with specialty outpatients care for gluten sensitivity of Hyogo College of Medicine.
Key exclusion criteria	none
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Yamada Middle name Last name Hisashi
Organization	hyogo college of medicine
Division name	department of psychiatry
Zip code	6638501
Address	1-1, mukogawa, nisinomiya city, hyogo
TEL	0798-45-6051
Email	hisa0820@hyo-med.ac.jp

Public contact
Name of contact person	1st name Yamada Middle name Last name Hisashi
Organization	hyogo college of medicine
Division name	department of psychiatry
Zip code	6638501
Address	1-1, mukogawa, nisinomiya city, hyogo
TEL	0798-45-6051
Homepage URL
Email	hisa0820@hyo-med.ac.jp

Sponsor
Institute	hyogo college of medicine department of psychiatry
Institute
Department

Funding Source
Organization	hyogo college of medicine department of psychiatry
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	hyogo college of medicine
Address	1-1, mukogawa, nisinomiya city, hyogo
Tel	0798-45-6094
Email	chiken02@hyo-med.ac.jp

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	2020 Year 01 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
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	2019 Year 10 Month 29 Day
Date of IRB	2020 Year 01 Month 01 Day
Anticipated trial start date	2020 Year 01 Month 01 Day
Last follow-up date	2020 Year 09 Month 30 Day
Date of closure to data entry	2020 Year 09 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 10 Month 29 Day
Last modified on	2020 Year 11 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043782

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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