UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041577 |
|---|---|
| Receipt number | R000046932 |
| Scientific Title | Alterations of gut microbiome and mucosal permeability in inactive IBD patients with IBS-like symptom |
| Date of disclosure of the study information | 2020/08/27 |
| Last modified on | 2020/08/27 17:15:56 |
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Basic information
Public title
Alterations of gut microbiome and mucosal permeability in inactive IBD patients with IBS-like symptom
Acronym
Alterations of gut microbiome and mucosal permeability in inactive IBD patients with IBS-like symptom
Scientific Title
Alterations of gut microbiome and mucosal permeability in inactive IBD patients with IBS-like symptom
Scientific Title:Acronym
Alterations of gut microbiome and mucosal permeability in inactive IBD patients with IBS-like symptom
Region
| Japan |
Condition
Condition
inactive IBD patients with IBS-like symptom
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aims of study are to evaluate the alteration of gut microbiome in inactive IBD patients with IBS-like symptom
Basic objectives2
Others
Basic objectives -Others
The aims of study are to evaluate the alteration of mucosal permeability in inactive IBD patients with IBS-like symptom
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
gut microbiome
Key secondary outcomes
1.mucosal permeability
2.inflammatory cytokine
3.short chain fatty acid
4.tight junction
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inactive IBD patients with IBS-like symptom aged 20-75 years and diagnosed according to the Rome III criteria
Key exclusion criteria
Candidates are excluded if any of the following are evident: current evidence of malignant disease or renal dysfuncti or liver dysfunction
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hiroto |
| Middle name | |
| Last name | Miwa |
Organization
Hyogo College of Medicine
Division name
Division of Gastroenterology,Department of Internal Medicine
Zip code
663-8501
Address
1-1,Mukogawa-cho,Nisinomiya,Hyogo 663-8501,Japan
TEL
+81-798-45-6662
miwahgi@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Toshihiko |
| Middle name | |
| Last name | Tomita |
Organization
Hyogo College of Medicine
Division name
Division of Gastroenterology and Hepatology,Department of Internal Medicine
Zip code
663-8501
Address
1-1,Mukogawa-cho,Nisinomiya,Hyogo 663-8501,Japan
TEL
+81-798-45-6662
Homepage URL
tomita@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
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
Hyogo College of Medicine
Address
1-1,Mukogawa-cho,Nisinomiya,Hyogo 663-8501,Japan
Tel
81798456662
tomita@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
兵庫医科大学病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 27 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 22 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2020 | Year | 08 | Month | 27 | Day |
Last modified on
| 2020 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046932
