UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038423 |
|---|---|
| Receipt number | R000043782 |
| Scientific Title | Specialty outpatients care for gluten sensitivity of Hyogo College of Medicine and therapeutic effects of gluten-free diet. |
| Date of disclosure of the study information | 2020/01/01 |
| Last modified on | 2020/11/02 11:58:06 |
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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
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
hisa0820@hyo-med.ac.jp
Sponsor or person
Institute
hyogo college of medicine department of psychiatry
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043782
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
