UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038700
Receipt number R000044122
Scientific Title Relationship between gluten sensitivity and physical/psychiatric symptoms, and the possibility of therapeutic effect of gluten free diet.
Date of disclosure of the study information 2019/11/28
Last modified on 2023/12/04 10:37:57

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Basic information

Public title

Relationship between gluten sensitivity and physical/psychiatric symptoms, and the possibility of therapeutic effect of gluten free diet.

Acronym

Relationship between gluten sensitivity and physical/psychiatric symptoms

Scientific Title

Relationship between gluten sensitivity and physical/psychiatric symptoms, and the possibility of therapeutic effect of gluten free diet.

Scientific Title:Acronym

Relationship between gluten sensitivity and physical/psychiatric symptoms

Region

Japan


Condition

Condition

schizophrenia, depression,eating disorder, irritable bowel syndrome, Inflammatory bowel disease, gluten intolerance

Classification by specialty

Medicine in general Gastroenterology Psychosomatic Internal Medicine
Pediatrics Psychiatry Adult
Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Firstly, to clarify the gluten sensitivity of Japanese patients with schizophrenia, depression, irritable bowel syndrome and Inflammatory bowel disease and thier relationships between physical/psychiatric symptoms and severity. Secondly, to investigate an effectiveness of gluten free diet for the 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 schizophrenia, depression, irritable bowel syndrome and Inflammatory bowel disease. To investigate the effectiveness of gluten free diet for the 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 Behavior,custom

Interventions/Control_1

gluten sensitive patients have gluten free diet for two weeks. Patients whose symptoms are improved 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

5 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

patient who met the criteria of depression, schizophrenia, irritable bowel syndrome and inflammatory bowel syndrome.
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

1200


Research contact person

Name of lead principal investigator

1st name Yamada
Middle name
Last name Hisashi

Organization

Hyogo medical university

Division name

department of neuropsychiatry

Zip code

663-8501

Address

1-1, mukogawa, nisinomiya, 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 neuropsychiatry

Zip code

663-8501

Address

1-1, mukogawatyo, nisinomiya city, hyogo

TEL

0798-45-6051

Homepage URL


Email

hisa0820@hyo-med.ac.jp


Sponsor or person

Institute

Hyogo medical university

Institute

Department

Personal name



Funding Source

Organization

Hyogo medical university

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 medical university

Address

1-1, mukogawatyo, nisinomiya city, hyogo

Tel

0798-45-6051

Email

hisa0820@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

2019 Year 11 Month 28 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

Open public recruiting

Date of protocol fixation

2019 Year 12 Month 01 Day

Date of IRB

2020 Year 01 Month 20 Day

Anticipated trial start date

2020 Year 02 Month 01 Day

Last follow-up date

2030 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

2019 Year 11 Month 27 Day

Last modified on

2023 Year 12 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044122


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name