UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034187 |
|---|---|
| Receipt number | 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 | 2020/03/23 19:34:45 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
hisa0820@hyo-med.ac.jp
Sponsor or person
Institute
hyogo medical college
department of psychiatry
Institute
Department
Personal name
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
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
Completed
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
| 2020 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037363
