NCT04618705

Brief Summary

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2023

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 6, 2020

Completed
2.5 years until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

July 14, 2023

Status Verified

February 1, 2023

Enrollment Period

1 month

First QC Date

October 21, 2020

Last Update Submit

July 12, 2023

Conditions

Smoking CessationWeight Gain

Keywords

Smoking cessationMicrobiomeWeight gain

Outcome Measures

Primary Outcomes (1)

  • Microbiome composition

    Stool and oral samples

    1 year

Secondary Outcomes (2)

  • Weight changes from baseline

    1 year

  • Blood glucose responses

    1 year

Study Arms (3)

control group

NO INTERVENTION

Participants who have not smoked for at least 10 years

smoking group

NO INTERVENTION

Participants who have smoked cigarettes (at least 5 cigarettes per day) for at least 2 years.

smoking cessation group

EXPERIMENTAL

Participants who have smoked cigarettes (at least 5 cigarettes per day) for at least 2 years and who are planning to quit smoking.

Behavioral: Smoking Cessation

Interventions

Smoking CessationBEHAVIORAL

Participants will start a smoking cessation program.

smoking cessation group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • BMI\<28
  • Capable of working with the smartphone application in Hebrew or English.

You may not qualify if:

  • 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
  • BMI\>28
  • Alcohol or substance abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • National Center for Chronic Disease Prevention and Health Promotion (US) Office on Smoking and Health. The Health Consequences of Smoking-50 Years of Progress: A Report of the Surgeon General. Atlanta (GA): Centers for Disease Control and Prevention (US); 2014. Available from http://www.ncbi.nlm.nih.gov/books/NBK179276/

    PMID: 24455788RESULT

  • Benowitz NL. Cigarette smoking and cardiovascular disease: pathophysiology and implications for treatment. Prog Cardiovasc Dis. 2003 Jul-Aug;46(1):91-111. doi: 10.1016/s0033-0620(03)00087-2. No abstract available.

    PMID: 12920702RESULT

  • Grando SA. Connections of nicotine to cancer. Nat Rev Cancer. 2014 Jun;14(6):419-29. doi: 10.1038/nrc3725. Epub 2014 May 15.

    PMID: 24827506RESULT

  • Grumelli S, Corry DB, Song LZ, Song L, Green L, Huh J, Hacken J, Espada R, Bag R, Lewis DE, Kheradmand F. An immune basis for lung parenchymal destruction in chronic obstructive pulmonary disease and emphysema. PLoS Med. 2004 Oct;1(1):e8. doi: 10.1371/journal.pmed.0010008. Epub 2004 Oct 19.

    PMID: 15526056RESULT

  • Costenbader KH, Karlson EW. Cigarette smoking and autoimmune disease: what can we learn from epidemiology? Lupus. 2006;15(11):737-45. doi: 10.1177/0961203306069344.

    PMID: 17153844RESULT

  • Dahlin S, Gunnerbeck A, Wikstrom AK, Cnattingius S, Edstedt Bonamy AK. Maternal tobacco use and extremely premature birth - a population-based cohort study. BJOG. 2016 Nov;123(12):1938-1946. doi: 10.1111/1471-0528.14213. Epub 2016 Jul 14.

    PMID: 27411948RESULT

  • Hackshaw A, Rodeck C, Boniface S. Maternal smoking in pregnancy and birth defects: a systematic review based on 173 687 malformed cases and 11.7 million controls. Hum Reprod Update. 2011 Sep-Oct;17(5):589-604. doi: 10.1093/humupd/dmr022. Epub 2011 Jul 11.

    PMID: 21747128RESULT

  • Harris KK, Zopey M, Friedman TC. Metabolic effects of smoking cessation. Nat Rev Endocrinol. 2016 Nov;12(11):684. doi: 10.1038/nrendo.2016.171. Epub 2016 Sep 30. No abstract available.

    PMID: 27688045RESULT

  • Martinez de Morentin PB, Whittle AJ, Ferno J, Nogueiras R, Dieguez C, Vidal-Puig A, Lopez M. Nicotine induces negative energy balance through hypothalamic AMP-activated protein kinase. Diabetes. 2012 Apr;61(4):807-17. doi: 10.2337/db11-1079. Epub 2012 Feb 7.

    PMID: 22315316RESULT

  • Chen H, Hansen MJ, Jones JE, Vlahos R, Anderson GP, Morris MJ. Long-term cigarette smoke exposure increases uncoupling protein expression but reduces energy intake. Brain Res. 2008 Sep 4;1228:81-8. doi: 10.1016/j.brainres.2008.06.067. Epub 2008 Jun 26.

    PMID: 18619427RESULT

  • Ussar S, Griffin NW, Bezy O, Fujisaka S, Vienberg S, Softic S, Deng L, Bry L, Gordon JI, Kahn CR. Interactions between Gut Microbiota, Host Genetics and Diet Modulate the Predisposition to Obesity and Metabolic Syndrome. Cell Metab. 2015 Sep 1;22(3):516-530. doi: 10.1016/j.cmet.2015.07.007. Epub 2015 Aug 20.

    PMID: 26299453RESULT

  • Turnbaugh PJ, Ley RE, Mahowald MA, Magrini V, Mardis ER, Gordon JI. An obesity-associated gut microbiome with increased capacity for energy harvest. Nature. 2006 Dec 21;444(7122):1027-31. doi: 10.1038/nature05414.

    PMID: 17183312RESULT

  • Hur KY, Lee MS. Gut Microbiota and Metabolic Disorders. Diabetes Metab J. 2015 Jun;39(3):198-203. doi: 10.4093/dmj.2015.39.3.198.

    PMID: 26124989RESULT

MeSH Terms

Conditions

Smoking CessationWeight Gain

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Eran Elinav, Prof

    Weizmann Institute of Science

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Parallel non-randomized study.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator, Host-Microbiome Interaction Research Group

Study Record Dates

First Submitted

October 21, 2020

First Posted

November 6, 2020

Study Start

May 1, 2023

Primary Completion

June 1, 2023

Study Completion

September 1, 2024

Last Updated

July 14, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share