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临床试验/NCT04618705
NCT04618705撤回不适用

The Role of the Gut Microbiome in Post-smoking Weight Gain

Eran Elinav0 个研究点开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
主要终点
Microbiome composition

研究概览

简要总结

Investigating the effect of smoking and smoking cessation on the intestinal microbial composition and function. The investigators wish to determine whether the alteration in gut microbiome drives the significant weight gain seen in humans after smoking cessation, and find the mechanism by which the gut microbiome contributes to this phenomenon.

详细描述

Cigarette smoking causes a variety of health problems, including cardiovascular disorders, cancer, pulmonary diseases, autoimmune diseases, premature birth, and certain birth defects. Health benefits of smoking cessation start very fast after the last smoke. However, smoking cessation has significant side effects including weight gain. Several theories have been proposed to explain weight gain after smoking cessation.

Microbiome research is an upcoming, extensively followed research field that has found unsuspected connections between human health and gut occupants. Many recent studies established important roles for the gut microbiome in regulating obesity, and metabolic diseases.

The general aim of this study is to investigate the effect of smoking and smoking cessation on the intestinal microbial composition and function.

This study follows 200 healthy participants who will be recruited according to their affiliation to one of three groups:

Group 1: Non-smokers for at least 10 years Group 2: Cigarette smokers that do not plan to quit. Group 3: Cigarette smokers who plan to quit smoking. Participants who are planning to quit cigarette smoking will be offered to join a program for smoking cessation. The study will start 8 days before cessation group volunteers will stop smoking and will continue for one year after. Participants of all groups will be followed-up for one year.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Non-smokers for at least 10 years, hereinafter 'control group'.
  • Cigarette smokers for at least 2 years, 5 or more cigarettes per day, that do not plan to quit hereinafter 'smoking group'.
  • Cigarette smokers for at least 2 years, 5 or more cigarettes per day, who plan to quit smoking hereinafter 'cessation group'.
  • Age - 18-70
  • Capable of working with the smartphone application in Hebrew or English.

排除标准

  • Consumption of antibiotics/oral antifungals/ probiotics 3 months before the first day of the experiment.
  • Constant consumption of drugs (cannabis etc..) in the last 2 years
  • Pregnancy in the last 6 months, breastfeeding, and active fertility treatments within the past year
  • Diagnosis of type 1 or type 2 diabetes
  • Chronic disease (infectious, autoimmune, endocrine, metabolic, neurodegenerative)
  • Cancer and recent anticancer treatment within the last 5 years
  • Neuro-psychiatric disorders
  • Coagulation disorders
  • Inflammatory bowel diseases (IBD)
  • Bariatric surgery within the last 5 years
  • Alcohol or substance abuse

结局指标

主要结局

Microbiome composition

时间窗: 1 year

Stool and oral samples

次要结局

  • Weight changes from baseline(1 year)
  • Blood glucose responses(1 year)

研究者

发起方
Eran Elinav
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Eran Elinav

Principal Investigator, Host-Microbiome Interaction Research Group

Weizmann Institute of Science

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