UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046106 |
|---|---|
| Receipt number | R000052632 |
| Scientific Title | A Prospective Observational Study to Elucidate the Mechanism of Gastrointestinal Mucosal Damage and Thrombosis in Patients with COVID-19 |
| Date of disclosure of the study information | 2021/11/22 |
| Last modified on | 2024/05/21 10:43:48 |
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Basic information
Public title
A Prospective Observational Study to Elucidate the Mechanism of Gastrointestinal Mucosal Damage and Thrombosis in Patients with COVID-19
Acronym
A Study to Elucidate the Gastrointestinal mucosal damage in Patients with COVID-19
Scientific Title
A Prospective Observational Study to Elucidate the Mechanism of Gastrointestinal Mucosal Damage and Thrombosis in Patients with COVID-19
Scientific Title:Acronym
A Study to Elucidate the Gastrointestinal mucosal damage in Patients with COVID-19
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Medicine in general | Gastroenterology | Pneumology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To elucidate the pathogenesis of gastrointestinal mucosal damage in patients with COVID-19.
Basic objectives2
Others
Basic objectives -Others
To elucidate the pathogenesis of thrombus formation associated with microcirculatory disturbances in COVID-19 patients.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The severity of COVID-19 and changes in gut microbiota or metabolites
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Male and female, ages 18 or older
2) Be willing to provide informed consent
3) SARS-CoV-2 nucleic acid detection by Real-Time PCR or SARS-CoV-2 antigen by a rapid diagnostic assay in the samples from the nasopharyngeal or oropharyngeal swab, or salvia.
Key exclusion criteria
1) Unconfirmed diagnosis for SARS-CoV-2
2) Rejection or Withdrawn of informed consent
3) Patients judged by the principal investigator to be ineligible.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Nakase |
Organization
Sapporo medical university
Division name
Department of gastroenterology and hepatology
Zip code
060-8543
Address
S1W16, Chuo-ku Sapporo, Hokkaido, Japan
TEL
0116112111
hiropynakase@gmail.com
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Yokoyama |
Organization
Sapporo medical university
Division name
Department of gastroenterology and hepatology
Zip code
060-8543
Address
S1W16, Chuo-ku Sapporo, Hokkaido, Japan
TEL
0116112111
Homepage URL
yoshi_yokoyamaa@yahoo.co.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Clinical Research, Research Support Division, Sapporo Medical University
Address
S1W16, Chuo-ku Sapporo, Hokkaido, Japan
Tel
011-611-2111
ji-rskk@sapmed.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 22 | Day |
Related information
URL releasing protocol
https://sapporo-med-gastroenterology.jp/patients/
Publication of results
Partially published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/36035409/
Number of participants that the trial has enrolled
58
Results
Serum interleukin-6 and fecal calprotectin were significantly higher in the critical illness group. Stool metabolome analysis showed that indole-3-propionic acid was significantly decreased in the critical illness group. The expression of genes that play an important role in tryptophan metabolism was decreased in the ileum of patients with severe COVID-19. These results indicate that inflammation of the gastrointestinal tract is caused by impaired tryptophan metabolism in severe COVID-19 patients.
Results date posted
| 2024 | Year | 05 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients diagnosed with COVID-19 at Sapporo Medical University Hospital and collaborating institutions
Participant flow
After obtaining consent from the patient, blood and stool samples were collected.
Adverse events
Not applicable because this is an observational study.
Outcome measures
Association between severity of illness and stool metagenomics and metabolomics in COVID-19 patients.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 09 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
For the analysis of gut microbiota and metabolites, samples will be collected again after one week.
Management information
Registered date
| 2021 | Year | 11 | Month | 18 | Day |
Last modified on
| 2024 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052632
