Elucidation of the effects of smoking cessation on gut microbiome, metabolites, and systemic inflammation

UMIN ID: UMIN000054308

Registered date:02/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: none
• Date of first enrollment: 2024/04/16
• Target sample size: 400
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: Comprehensive analysis of the bacterial flora in stools will be performed before and after smoking cessation and compared.
• Secondary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Keio University
• Source(s) of Monetary Support: Keio University