Protocol summary

Summary
The aim of this study is to determine the effect of Probiotic capsule supplementation on oxidative stress in patients with Major Depressive Disorder under treatment with Fluoxetine. study design: randomized double-blinded controlled clinical trial. Inclusion Criteria: patients with Major Depressive based on DSM-IV-TR criteria that they have not used any nutritional supplements, antiinflammatory and antidepressant drugs at least 2 months prior to intervention; aged 18 to 65 years; at least score 15 on Hamilton Depression Rating Scale 17 (HDRS-17). Exclusion Criteria: pregnancy and lactation; drug abuse within 6 months prior to intervention; psychosis; any type of severe chronic physical illness; any extreme and severe mental disorders (suicidal ideation, psychotic symptoms, symptoms of manic phase, etc); compliance rate less than% 80; consuming Probiotic foods during intervention. population and sample size: 44 patients with Major Depressive Disorder of eligible and referred from Roozbeh hospital to Tehran University of Medical Sciences. intervention: patients will be assigned to receive either the probiotic capsule (intervention group: n=22) or placebo capsule (control group: n=22). blood samples will be taken at baseline and after 8-wk intervention. intervention: 8 weeks. Outcomes: Serum Catalase, Arylstrase activity of Paraxonase, Homocystein, Oxidized-LDL, MDA, hs-CRP and plasma Fibrinogen will be measured at the beginning and end of the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201611292394N34
Registration date: 2017-01-02, 1395/10/13
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-01-02, 1395/10/13
Registrant information
Name
Shima Jazayeri
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4805
Email address
sjazayeri@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Probiotic supplementation on oxidative stress in patients with Major Depressive Disorder
Public title
Effect of Probiotic supplementation on oxidative stress
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:patients with Major Depressive based on DSM-IV-TR criteria that they have not used any nutritional supplements, antiinflammatory and antidepressant drugs at least 2 months prior to intervention; aged 18 to 65 years; at least score 15 on Hamilton Depression Rating Scale 17 (HDRS-17). Exclusion Criteria: pregnancy and lactation; drug abuse within 6 months prior to intervention; psychosis; any type of severe chronic physical illness; any extreme and severe mental disorders (suicidal ideation, psychotic symptoms, symptoms of manic phase, etc); compliance rate less than% 80; consuming probiotic foods during intervention.
Age
From 77 years old to 30 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
-
Secondary trial Id
-
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committe of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmet Highway, Tehran, Iran
City
Tehran
Postal code
Approval date
2016-11-19, 1395/08/29
Ethics committee reference number
IR.IUMS.REC.1395.9313680001

Health conditions studied

1

Description of health condition studied
Major Depressive Disorder
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Catalase
Timepoint
Begining and end of intervention
Method of measurement
Colorimetry

2

Description
Homocystein
Timepoint
Begining and end of intervention
Method of measurement
ELIZA

3

Description
Oxidized -LDL
Timepoint
Begining and end of intervention
Method of measurement
ELIZA

4

Description
MDA
Timepoint
Begining and end of intervention
Method of measurement
Colorimetry

5

Description
Arylstrase activity of Paraxonase
Timepoint
Begining and end of intervention
Method of measurement
Colorimetry

6

Description
hs-CRP
Timepoint
Begining and end of intervention
Method of measurement
ELIZA

7

Description
Fibrinogen
Timepoint
Begining and end of intervention
Method of measurement
Coagulation

Secondary outcomes

1

Description
Energy intake
Timepoint
Begining and end of intervention
Method of measurement
24-hour recall

2

Description
Physical activity
Timepoint
Begining and end of intervention
Method of measurement
IPAQ questionnaire

3

Description
Side effect
Timepoint
End of forth week and end of intervention
Method of measurement
Side effect questionnaire

4

Description
Weight
Timepoint
Begining and end of intervention
Method of measurement
Scale

Intervention groups

1

Description
Control, Placebo
Category
Placebo

2

Description
Intervention, Multi species Probiotic capsules containing 3×109 CFU Lactobacillus Helveticus and Bifidbacterium Longum
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Roozbeh hospital, Tehran University of Medical Science
Full name of responsible person
Shirin Tajadod
Street address
Roozbeh hospital, South Kargar Ave, Enghelab Sq, Tehran, Iran.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Dr. Seyed Ali Javad Moosavi
Street address
Vice chancellor for research, Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, Iran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Department of Nutrition, School of Public Health, Iran University of Medical Sciences.
Full name of responsible person
Shirin Tajadod
Position
MSc Student of Nutrition
Other areas of specialty/work
Street address
Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 8670 4805
Fax
Email
tajadod.shirin@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Nutrition, School of Public Health, Iran University of Medical Sciences
Full name of responsible person
Dr. Shima Jazayeri
Position
MD, PhD.
Other areas of specialty/work
Street address
Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 8670 4805
Fax
Email
sh_jaz@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Department of Nutrition, School of public Health, Iran University of Medical Science
Full name of responsible person
Shirin Tajadod
Position
MSc Student of Nutrition
Other areas of specialty/work
Street address
Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, Iran.
City
Tehran
Postal code
Phone
00
Fax
Email
tajadod.shirin@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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