Effect of probiotic in cigarette smokers

The effects of probiotic supplementation on nicotine dependence, mental health, and metabolic biomarkers in cigarette smokers

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20170420033551N13

Enrollment

Registered

2022-12-06

Start date

2023-01-04

Completion date

Unknown

Last updated

2023-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nicotine dependence in cigarette smokers. Nicotine dependence, cigarettes

Interventions

Intervention 1: Intervention group: Intervention group: Probiotic oral capsule containing four strains of Lactobacillus acidophilus (2×109 CFU/g), Bifidobacterium lactis (2×109 CFU/g), Bifidobacterium

Eligibility

Sex/Gender

All

Age

17 Years to 50 Years

Inclusion criteria

Inclusion criteria: Smoking dependence ((Fagström test score is more than 4). Age of 17 to 50 years old Complete informed consent People have a history of continuous smoking for at least one year. People should have a pack of cigarettes for at least two days.

Exclusion criteria

Exclusion criteria: Unwillingness to cooperate Taking probiotic, anti-inflammatory and antioxidant supplements during the last 3 months before the intervention. History of metabolic diseases including diabetes, HIV/AIDS, thyroid, cardiovascular disease, and liver and kidney disorders. High blood pressure Pregnant women Positive urine test for morphine, methamphetamine and cannabis Use of psychiatric and neurological drugs such as benzodiazepines and antidepressants People have a history of drug use (opium, heroin, crack, methamphetamine, and hashish).

Design outcomes

Primary

Measure	Time frame
Nicotine Dependence Syndrome Scale. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire.;Depression beck score. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire.;Anxiety beck score. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire.	—

Measure

Time frame

Nicotine Dependence Syndrome Scale. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire.;Depression beck score. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire.;Anxiety beck score. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire.

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Secondary

Measure	Time frame
Total antioxidant. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Total glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Fasting plasma glucose. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;HDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;VLDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;LDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.	—

Measure

Time frame

Total antioxidant. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Total glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Fasting plasma glucose. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;HDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;VLDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;LDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmir Ghaderi

Kashan University of Medical Sciences

gaderiam@yahoo.com+98 31 5546 3378

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026