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UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034187
Receipt No. R000037363
Scientific Title Gluten sensitivity among the patients with Inflammatory Bowel Disease and the possibility of therapeutic effect of gluten free diet
Date of disclosure of the study information 2018/10/01
Last modified on 2019/03/22

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Basic information
Public title Gluten sensitivity among the patients with Inflammatory Bowel Disease and the possibility of therapeutic effect of gluten free diet
Acronym Gluten sensitivity in Inflammatory Bowel Disease
Scientific Title Gluten sensitivity among the patients with Inflammatory Bowel Disease and the possibility of therapeutic effect of gluten free diet
Scientific Title:Acronym Gluten sensitivity in Inflammatory Bowel Disease
Region
Japan

Condition
Condition Inflammatory Bowel Disease
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Firstly, to clarify the gluten sensitivity of Japanese patients with inflammatory bowel disease and its relationships between physical/psychiatric symptoms and severity. Secondly, to investigate an effectiveness of gluten free diet for the inflammatory bowel disease 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 inflammatory bowel disease.
To investigate the effectiveness of gluten free diet for the inflammatory bowel disease 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 antibody levels of tissue transglutaminase IgA antibody, the deamidated gliadin peptide IgA antibody, gliadin IgA antibody, gliadin IgG anti body.
The effectiveness of gluten free diet is assessed by CDAI, Lichtiger Index, GAD-7, PHQ-9 and PHQ-15 before and two weeks later of taking gluten free diet. Improved patients is assessed at four and eight weeks.
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 gluten sensitive patients with Inflammatory Bowel Disease have gluten free diet for two weeks and assess an effectiveness of gluten free diet
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

Not applicable
Gender Male and Female
Key inclusion criteria schizophrenia in the Inflammatory Bowel Disease
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 patinet who can't provide written informed consent
patient with severe cardiac or liver insufficiency
Target sample size 200

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
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
2018 Year 10 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 Enrolling by invitation
Date of protocol fixation
2018 Year 10 Month 01 Day
Date of IRB
2018 Year 10 Month 01 Day
Anticipated trial start date
2018 Year 10 Month 01 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
2018 Year 09 Month 18 Day
Last modified on
2019 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037363

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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