UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057281 |
|---|---|
| Receipt number | R000065478 |
| Scientific Title | Elucidation of the association of intestinal bacteria and metabolites with exacerbations of chronic obstructive pulmonary disease or pneumonia associated with COPD. |
| Date of disclosure of the study information | 2025/03/13 |
| Last modified on | 2026/04/13 09:38:59 |
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Basic information
Public title
Elucidation of the association of intestinal bacteria and metabolites with exacerbations of chronic obstructive pulmonary disease or pneumonia associated with COPD.
Acronym
KCER
Scientific Title
Elucidation of the association of intestinal bacteria and metabolites with exacerbations of chronic obstructive pulmonary disease or pneumonia associated with COPD.
Scientific Title:Acronym
KCER
Region
| Japan |
Condition
Condition
COPD exacerbation or pneumonia in COPD patients
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The goal of this study was to elucidate the relationship between COPD exacerbations and intestinal bacteria and metabolites produced by intestinal bacteria by asking patients with COPD exacerbations to complete questionnaires, blood samples, stool samples, and other measurements.
Basic objectives2
Others
Basic objectives -Others
In this study, the pathophysiology will be elucidated by observation.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoints of this study will be a comprehensive analysis of the bacterial flora in stools and evaluation of blood and stool metabolites.
Key secondary outcomes
Secondary endpoints of this study will include assessment of systemic inflammation and in vivo characterization of the intestinal microbiota in the stool.
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
(i) COPD patients who meet the clinical diagnosis of COPD exacerbation or pneumonia.
(ii) Patients who are 20 years of age or older.
(iii) Those who have given written consent to participate in this study.
Key exclusion criteria
(i) Persons with a history of intestinal tract surgery.
(ii) Persons who are deemed inappropriate to conduct this study by the Principal Investigator or Research Supervisor.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Fukunaga |
Organization
Keio University Hospital
Division name
Division of Pulmonary Medicine
Zip code
1608582
Address
35, Shinanomachi, Shinjyuku-ku, Tokyo, JAPAN
TEL
03-5363-3793
bachibachi472000@keio.jp
Public contact
Name of contact person
| 1st name | Shotaro |
| Middle name | |
| Last name | Chubachi |
Organization
Keio University Hospital
Division name
Division of Pulmonary Medicine
Zip code
1608582
Address
35, Shinanomachi, Shinjyuku-ku, Tokyo, JAPAN
TEL
03-5363-3793
Homepage URL
bachibachi472000@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Saitama Medical Canter/ Tokyo Saiseikai Central Hospital/ Tokyo University of Agriculture and Technology
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University
Address
35, Shinanomachi, Shinjyuku-ku, Tokyo, JAPAN
Tel
03-5363-3793
bachibachi472000@keio.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
| 2025 | Year | 03 | Month | 13 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 03 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Subjects will be patients diagnosed with COPD exacerbation or pneumonia who visit the outpatient department of respiratory medicine at Keio University Hospital and the collaborating institutions. At the time of consent, one week after completion of treatment, and two to three months later at follow-up visits, patients will undergo a lifestyle survey, blood samples, stool samples, and weight measurements, respectively. In addition, information on medical information, age, gender, and height within the daily medical treatment will be obtained from the medical record.
Management information
Registered date
| 2025 | Year | 03 | Month | 13 | Day |
Last modified on
| 2026 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065478
