Unique ID issued by UMIN | UMIN000044047 |
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Receipt number | R000050113 |
Scientific Title | Prospective observational study of stool metagenome and metabolome analysis of patients with inflammatory bowel disease aiming to develop IBD omics score for the predict of relapse |
Date of disclosure of the study information | 2021/05/07 |
Last modified on | 2021/04/26 14:50:33 |
Prospective observational study of stool metagenome and metabolome analysis of patients with inflammatory bowel disease aiming to develop IBD omics score for the predict of relapse
Prospective observational study of stool metagenome and metabolome analysis of patients with inflammatory bowel disease aiming to develop IBD omics score for the predict of relapse
Prospective observational study of stool metagenome and metabolome analysis of patients with inflammatory bowel disease aiming to develop IBD omics score for the predict of relapse
Prospective observational study of stool metagenome and metabolome analysis of patients with inflammatory bowel disease aiming to develop IBD omics score for the predict of relapse
Japan |
inflammatory bowel disease
Gastroenterology |
Others
NO
Perform stool metagenomic and metabolome analysis of patients with inflammatory bowel disease aiming to develop IBD omics score for the predict of relapse
Others
Perform stool metagenomic and metabolome analysis of patients with inflammatory bowel disease aiming to develop IBD omics score for the predict of relapse
Analysis of omics data of IBD patients in remission: Use metagenomic analysis, metabolome analysis, and transcriptome analysis at enrollment
The development of IBD omics score for predict of relapse: Examine IBD patients who maintained remission by 52 weeks and IBD patients who relapsed within 52 weeks using metagenomic analysis, metabolome analysis, and transcriptome analysis.
Observational
16 | years-old | <= |
Not applicable |
Male and Female
Patients in clinical remission(Crohn's disease: maintain Harvey-Bradshaw index 3 or less for 3 months or more. Ulcerative colitis: Maintain Partial Mayo 1 and less for 3 months or more.
Patients 16 years and over at the time of consent acquisition
Patients who voluntarily consented in writing after receiving sufficient explanation for participation in this study
Patients with unconfirmed diagnosis
Patients receiving steroids
Patients taking antithrombotic drugs
Patients who do not consent to this study
Patients judged to be ineligible by the research director
100
1st name | Hiroshi |
Middle name | |
Last name | Nakase |
Sapporo Medical University School of Medicine
Department of Gastroenterology and Hepatology
060-8543
South 1 West 16, Chuo-ku, Sapporo, Japan
011-611-2111
hiropynakase@gmail.com
1st name | Kohei |
Middle name | |
Last name | Wagasuma |
Sapporo Medical University School of Medicine
Department of Gastroenterology and Hepatology
060-8543
South 1 West 16, Chuo-ku, Sapporo, Japan
011-611-2111
k.wagatsuma@sapmed.ac.jp
Department of Gastroenterology and Hepatology, Sapporo Medical University School of Medicine
Self funding
Self funding
Clinical Research Section, Research Support Section, Secretariat, Sapporo Medical University
South 1 West 17, Chuo-ku, Sapporo, Japan
011-611-2111
ji-rskk@sapmed.ac.jp
NO
札幌医科大学医学部 消化器内科学講座(北海道)
2021 | Year | 05 | Month | 07 | Day |
Unpublished
Enrolling by invitation
2020 | Year | 08 | Month | 06 | Day |
2020 | Year | 09 | Month | 10 | Day |
2020 | Year | 10 | Month | 01 | Day |
2026 | Year | 03 | Month | 31 | Day |
(1): Collection of patient clinical data
(2): Metagenomic analysis and metabolome analysis of micobiota by feces at the enrollment. If possible, add oral bacterial flora analysis
(3): Transcriptome analysis at the enrollment using colon tissue by biopsy at colonoscopy.
(4): Analyze the omics data at the enrollment based on the information obtained in (1) to (3).
(5): From the time of enrollment, follow-up is performed every 4 to 12 weeks (+/- 2 weeks) for up to 52 weeks (+/- 8 weeks) to evaluate remission or relapse.
(6): Perform metagenomic analysis and metabolome analysis by feces of patients with remission / relapse. If possible, perform transcriptome analysis using colon tissue by biopsy at colonoscopy. Collect these data to develop a IBD omics score for the predict of relapse.
2021 | Year | 04 | Month | 26 | Day |
2021 | Year | 04 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050113
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