Effect of probiotic supplementation in treatment of methadone maintenance treatment patients

The effect of probiotic capsule supplementation on clinical symptoms, lipid profiles, insulin sensitivity, inflammatory factors and biomarkers of oxidative stress in substance dependent patients under methadone maintenance treatment

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20170420033551N9

Enrollment

Registered

2020-03-22

Start date

2020-04-17

Completion date

Unknown

Last updated

2020-04-21

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

Conditions

Addiction. Other psychoactive substance related disorders

Interventions

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

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Patients under methadone maintenance treatment Age of 18 to 60 years old

Exclusion criteria

Exclusion criteria: Unwillingness to cooperate Taking probiotic, multivitamin-mineral and antioxidant supplements during the last 3 months before the intervention Current severe depression and mania Psychosis Major cardiovascular disorder

Design outcomes

Primary

Measure	Time frame
Depression. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Beck Depression Inventory (BDI).;Anxiety. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Beck Anxiety Inventory (BAI).	—

Secondary

Measure	Time frame
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.;Triglycerides. 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.;HDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Total antioxidant. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;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.;Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.	—

Measure

Time frame

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.;Triglycerides. 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.;HDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Total antioxidant. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;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.;Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmir Ghaderi

Kashan University of Medical Sciences

gaderiam@yahoo.com+98 31 5554 0021

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 13, 2026