UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054308 |
|---|---|
| Receipt number | R000061792 |
| Scientific Title | Elucidation of the effects of smoking cessation on gut microbiome, metabolites, and systemic inflammation |
| Date of disclosure of the study information | 2024/05/02 |
| Last modified on | 2025/09/25 10:58:43 |
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Basic information
Public title
Elucidation of the effects of smoking cessation on gut microbiome, metabolites, and systemic inflammation
Acronym
KSCR
Scientific Title
Elucidation of the effects of smoking cessation on gut microbiome, metabolites, and systemic inflammation
Scientific Title:Acronym
KSCR
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the relationship between systemic inflammation associated with smoking and the intestinal microflora and metabolites produced by them.
Basic objectives2
Others
Basic objectives -Others
Comprehensive analysis of the bacterial flora in stool before and after smoking cessation as well as metabolites in blood and stool will be evaluated in this study.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Comprehensive analysis of the bacterial flora in stools will be performed before and after smoking cessation and compared.
Key secondary outcomes
Evaluation of blood and stool metabolites, systemic inflammation, and in vivo characteristics of the intestinal microflora in the stool, measurement of salivary cotinine to assess nicotine in the body, and assessment of living conditions using a questionnaire will be conducted before and after smoking cessation and compared.
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
A. Smoking cessation clinic patients:
(1) Japanese nationals 20 years of age or older.
(2) Those who have started their first visit to a smoking cessation clinic.
(3) Have given written consent to participate in this study.
B. Healthy volunteers:
(1) Japanese who are 20 years of age or older
(2) Non-smokers
(3) Have given written consent to participate in this study.
Key exclusion criteria
A. Smoking cessation clinic patients:
(1) Patients who have already quit smoking at the time of their first visit to a smoking cessation clinic
(2) Patients with a history of intestinal tract surgery
(3) Persons deemed inappropriate by the principal investigator or subinvestigator to conduct this study.
B. Healthy volunteers:
(1) Those who have a history of intestinal tract surgery
(2) Persons with a history of smoking in the past
(3) Persons who are deemed inappropriate by the principal investigator or subinvestigator to conduct this study.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Fukunaga |
Organization
Keio University School of Medicine
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 School of Medicine
Division name
Division of Pulmonary Medicine
Zip code
1608582
Address
35, Shinanomachi, Shinjyuku-ku, Tokyo, JAPAN
TEL
03-5363-3793
Homepage URL
bachibachi472000@z6.keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio 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
Keio University
Address
35, Shinanomachi, Shinjyuku-ku, Tokyo, JAPAN
Tel
03-5363-3793
bachibachi472000@z6.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
| 2024 | Year | 05 | Month | 02 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 16 | 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
The subjects will be patients at Keio University Hospital smoking cessation outpatients, and healthy subjects aged 20 years or older will be used as comparison subjects.
Smoking cessation outpatients will have blood samples, stool samples, saliva samples, a questionnaire survey of their living conditions, and weight measurements at the initial visit and 12 weeks after the final visit, which is the end of the smoking cessation outpatient insurance reimbursement period, respectively. In addition, 24 weeks after the initial visit (12 weeks after the final visit), the patient will be asked to come to the hospital for blood, stool, saliva, and questionnaire surveys of living conditions, weight measurement, and exhaled CO measurement. In addition, medical information, age, gender, height, smoking cessation start date, and exhaled carbon monoxide concentration will be obtained from the medical record.
For healthy subjects, blood samples, stool samples, questionnaire survey of living conditions, weight measurement, and height interview will be conducted once.
The questionnaire will include a history of medical history and comorbidities, medications including over-the-counter drugs and supplements, diet (Brief-type Self-administered Diet History Questionnaire; BDHQ), health food intake, amount of exercise, amount of stress (PSS-10), sleep duration, and weight change.
Management information
Registered date
| 2024 | Year | 05 | Month | 02 | Day |
Last modified on
| 2025 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061792
