Unique ID issued by UMIN | UMIN000038461 |
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Receipt number | R000043830 |
Scientific Title | Investigation of intestinal permeability in inflammatory bowel disease using a novel evaluation method (Phas I, II study) |
Date of disclosure of the study information | 2019/11/01 |
Last modified on | 2020/05/02 11:00:04 |
Investigation of intestinal permeability in inflammatory bowel disease using a novel evaluation method (Phase I, II study)
A novel evaluation method for intestinal permeability
Investigation of intestinal permeability in inflammatory bowel disease using a novel evaluation method (Phas I, II study)
A novel evaluation method for intestinal permeability
Japan |
Inflammatory bowel disease (IBD)
Gastroenterology |
Others
NO
The aim of this study is to investigate intestinal permeability for IBD patients and clarify its clinical importance.
Safety,Efficacy
Determination of chitosan dose for administarion (Phase I: after 1 and 4 hours) and evaluation of symptoms and blood examination (Phase I: by 1 month). Correlation between blood concentration level of chitosan and disease activity of IBD (Phase II. at administration).
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Diagnosis
Food |
chitosan
20 | years-old | <= |
70 | years-old | >= |
Male and Female
Patients with Crohn's disease and ulcerative colitis
Patients who physicians judge as inappropriate
132
1st name | Shunji |
Middle name | |
Last name | Ishihara |
Shimane University Faculty of Medicine
Internal Medicine II
693-8501
Enya-cho 89-1, Izumo, ShImane
0853-20-2190
si360405@med.shimane-u.ac.jp
1st name | Shunji |
Middle name | |
Last name | Ishihara |
Shimane University Faculty of Medicine
Internal Medicine II
693-8501
Enya-cho 89-1, Izumo, ShImane
0853-20-2190
si360405@med.shimane-u.ac.jp
Shimane University Faculty of Medicine
Internal Medicine II
Shimane University Faculty of Medicine
Internal Medicine II
Other
Medical Ethics Committee of Shimane University
Enya-cho 89-1, Izumo, ShImane
0853-20-2515
kenyu@med.shimane-u.ac.jp
NO
2019 | Year | 11 | Month | 01 | Day |
N/A
Unpublished
N/A
22
Seventeen patients and 5 controls were enrolled. However, blood concentration levels of chitosan were less than cut-off or very low. We re-consider the study protocol.
2020 | Year | 05 | Month | 02 | Day |
IBD patients Healthy control
outpatients clinic, laboratory room
bo adverse events
safety, blood concentration level of chitosan
Suspended
2018 | Year | 05 | Month | 25 | Day |
2018 | Year | 05 | Month | 25 | Day |
2018 | Year | 08 | Month | 05 | Day |
2019 | Year | 03 | Month | 31 | Day |
2019 | Year | 11 | Month | 01 | Day |
2020 | Year | 05 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043830
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