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IRCT20170420033551N9 IRCT 2020-03-22 Kashan University of Medical Sciences 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 2020-04-17 anticipated 70 Complete https://irct.ir/trial/46363 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be performed with simple method and random numbers generated by computer software (Stat Trek software) which choose the random numbers. Then, we consider the specific numbers for both groups for example: the even numbers are for intervention group and the odd numbers are for the placebo group, Blinding description: Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of supplements. Supplements and placebos are in the same packaging at the Barij Essence pharmaceutical company. Only the code is written on the packages. Patients and researcher do not know the type of intervention and after analyzing the data, packet codes are decoded. 3 Addiction. 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/g) and bifidobacterium longum (2×109 CFU/g), daily, for 12 weeks. Intervention 2: Control group: Placebo, daily, for 12 weeks orally. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Undecided - It is not yet known if there will be a plan to make this available
public Amir Ghaderi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8814187159 +98 31 5554 0021 gaderiam@yahoo.com Kashan University of Medical Sciences scientific Amir Ghaderi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8814187159 +98 31 5554 0021 gaderiam@yahoo.com Kashan University of Medical Sciences Iran (Islamic Republic of) Patients under methadone maintenance treatment Age of 18 to 60 years old 18 years 60 years Both 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 F19 Other psychoactive substance related disorders Treatment - Drugs Treatment - Drugs 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/g) and bifidobacterium longum (2×109 CFU/g), daily, for 12 weeks. Control group: Placebo, daily, for 12 weeks orally. 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). 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. Kashan University of Medical Sciences Approved 2020-01-06 Ethics committee of Kashan University of Medical Sciences Ghotbe Ravandi Boulevard, Kashan Kashan Isfehan Iran (Islamic Republic of)