Protocol summary

Study aim
The aim of this study is to determine the effects of Probiotic supplementation on mental health parameters and metabolic profiles in methadone maintenance treatment patients
Design
Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial.
Settings and conduct
Population and sample size: among patients under methadone maintenance treatment referred to Sultan Mir Ahmad Clinic affiliated to Kashan University of Medical Sciences, 70 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. Time of intervention: 12 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients on methadone maintenance treatment and aged 18 to 60 years old will be included in this study. Exclusion criterion: unwillingness to cooperate.
Intervention groups
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: probiotic placebos capsule, daily for 12 weeks orally.
Main outcome variables
Depression; anxiety (primary outcome) and fasting plasma glucose; Insulin; triglycerides; total cholesterol; HDL; Hs-CRP; total antioxidant; glutathione; malondialdehyde (secondary outcome).

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170420033551N9
Registration date: 2020-03-22, 1399/01/03
Registration timing: prospective

Last update: 2020-03-22, 1399/01/03
Update count: 0
Registration date
2020-03-22, 1399/01/03
Registrant information
Name
Amir Ghaderi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 918 771 7435
Email address
ghaderi-am@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-17, 1399/01/29
Expected recruitment end date
2020-05-18, 1399/02/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Effect of probiotic supplementation in treatment of methadone maintenance treatment patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients under methadone maintenance treatment Age of 18 to 60 years old
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
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Approval date
2020-01-06, 1398/10/16
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1398.116

Health conditions studied

1

Description of health condition studied
Addiction
ICD-10 code
F19
ICD-10 code description
Other psychoactive substance related disorders

Primary outcomes

1

Description
Depression
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Beck Depression Inventory (BDI)

2

Description
Anxiety
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Beck Anxiety Inventory (BAI)

Secondary outcomes

1

Description
Fasting plasma glucose
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

2

Description
Insulin
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit

3

Description
Triglycerides
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

4

Description
Total cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

5

Description
HDL
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

6

Description
Hs-CRP
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit

7

Description
Total antioxidant
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry

8

Description
Glutathione
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry

9

Description
Malondialdehyde
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry

10

Description
Nitric oxide
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry

Intervention groups

1

Description
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.
Category
Treatment - Drugs

2

Description
Control group: Placebo, daily, for 12 weeks orally.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Sultan Mir Ahmad Clinic
Full name of responsible person
Amir Ghaderi
Street address
Motahari Avenue, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5554 6769
Email
gaderiam@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamid Reza Banafshe
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 5554 2999
Email
banafshe57@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Amir Ghaderi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Ph.D of addiction
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 5554 0021
Email
gaderiam@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Amir Ghaderi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Ph.D of addiction
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 5554 0021
Email
gaderiam@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Amir Ghaderi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Ph.D of addiction
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 5554 0021
Email
gaderiam@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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