UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051273 |
|---|---|
| Receipt number | R000058480 |
| Scientific Title | Evaluation of a diagnostic COVID-19 infection based on fecal analysis and consideration of the risks in endoscopic procedures |
| Date of disclosure of the study information | 2023/06/06 |
| Last modified on | 2026/06/27 11:45:54 |
* 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
Fecal PCR test with COVID-19 during endoscopic procedures
Acronym
COVID-19 fecal PCR test
Scientific Title
Evaluation of a diagnostic COVID-19 infection based on fecal analysis and consideration of the risks in endoscopic procedures
Scientific Title:Acronym
Effect of COVID-19 infection on the gastrointestinal tract considering preventive methods during endoscopic procedures
Region
| Japan |
Condition
Condition
patients with diagnosed COVID-19
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evaluate the risk of infection in patients with coronavirus disease 2019 (COVID-19) in relation to the gastrointestinal tract using fecal polymerase chain reaction (PCR) tests.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The detection of SARS-Cov-2 in human stool samples in nasal mucosa PCR-positive individuals
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed COVID-19 with nasal PCR-positive at Tokyo Medical University Hospital, and obtained informed consent
Key exclusion criteria
Patients who could not give consent to participate in this study.
Those who have serious complications (heart failure, renal failure, liver failure, respiratory failure)
Other patients who are deemed inappropriate to participate in this study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Sakiko |
| Middle name | |
| Last name | Naito |
Organization
Tokyo Medical University
Division name
Department of Gastroenterology and Hepatology
Zip code
160-0023
Address
6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo, Japan
TEL
0333426111
sakiko-n@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Sakiko |
| Middle name | |
| Last name | Naito |
Organization
Tokyo Medical University
Division name
Department of Gastroenterology and Hepatology
Zip code
160-0023
Address
6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo, Japan
TEL
0333426111
Homepage URL
sakiko-n@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical University
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
Tokyo Medical University
Address
6-7-1,Nishishinjuku, Shinjuku-ku, Tokyo, Japan
Tel
0333426111
sakiko-n@tokyo-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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 06 | Day |
Related information
URL releasing protocol
https://tokyo-med.bvits.com/irb/publish.aspx
Publication of results
Published
Result
URL related to results and publications
https://tokyo-med.bvits.com/irb/publish.aspx
Number of participants that the trial has enrolled
32
Results
Among the 32 nasal PCR-positive patients who underwent fecal
PCR testing, the fecal PCR positivity rate was 21.8%. Compared to the negative cases, 71.4% vs. 32% were older than 65 years (p < 0.016), 71.4% vs.
0.8% (p < 0.001) had malignant tumors, the rate during BA.5 variant outbreaks was significantly higher (100% vs. 60% [p = 0.044]), and the rate of
diarrheal symptoms was also higher (42.9% vs. 24%). The median collection
period for fecal PCR-positive cases was 2 days after sampling.
Results date posted
| 2026 | Year | 06 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
COVID19positive
Participant flow
This was a single-center prospective observational
study involving 32 patients diagnosed with COVID-19
at Tokyo Medical University Hospital between January and December 2022.
Adverse events
Nothing
Outcome measures
Fecal Positivity Rate Among COVID-19 Patients
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 05 | Month | 07 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
Nothing
Management information
Registered date
| 2023 | Year | 06 | Month | 06 | Day |
Last modified on
| 2026 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058480
