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Effects of consumption of probiotic on symptom severity , quality of life, plasma ACTH and serum cortisol in patients with generalized anxiety disorder

Protocol summary

Summary
Objectives: The aim of this study is to determine effects of probiotic on symptom severity, quality of life, plasma ACTH and serum cortisol in patients with generalized anxiety disorder. 2- Design: double blind randomized controlled trial 3- Setting and conduct: Fifty patients with generalized anxiety will be referred from Ziaeian Clinic. They will be randomly allocated to receive daily either probiotic supplement or placebo for 8 weeks. Symptom severity of Anxiety will be assessed by Beck Anxiety Inventory, Scale for anxiety and State-Trait Anxiety Inventory questionnaires and quality of life will be assessed by World health organization Quality of Life Questionnaire, in week 0, 4 and 8. For measurement of plasma ACTH and serum cortisol,ten milliliters of venous fasting blood sample will be collected at baseline and after intervention. 4- Participants: patients with generalized anxiety disorder aged 18-65 years, Exclusion criteria: Having any illness including liver disease, kidney disease, diabetes, immune deficiency, etc, Having psychological illnesses including psychosis, Suicidal ideation, bipolar disorder and major depression, taking any medication in the previous 1 month, taking any medication related to psychiatric diseases including antidepressants, antipsychotics (maximum twice a week) and antibiotics in the previous 1 month. 5- Intervention: probiotic (18×109 CFU) or placebo daily for 8 weeks 6- Main outcome measures variables: Symptom severity, plasma ACTH, serum cortisol and quality of life.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201612072394N35
Registration date: 2017-03-04, 1395/12/14
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-03-04, 1395/12/14
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
2016-12-21, 1395/10/01
Expected recruitment end date
2017-10-22, 1396/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of consumption of probiotic on symptom severity , quality of life, plasma ACTH and serum cortisol in patients with generalized anxiety disorder
Public title
Effects of probiotic in generalized anxiety disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: DSM-V diagnosed of GAD; Adults between 18 and 65 years old; Willing to participate. exclusion criteria: Having illness including liver disease and kidney disease, diabetes, immune deficiency, etc; Having psychological illnesses including psychosis, Suicidal ideation, bipolar disorder and major depression; People who are expected to have limited partnerships such as forgetfulness and pregnancy; Taking any medication in the previous 1 month; Taking any medication related to psychiatric diseases including antidepressants, antipsychotics, etc. (maximum of two times per week) and antibiotics in the previous 1 month; Taking any supplement including probiotic supplement, fiber, prebiotics, omega-3, vitamins and minerals in the previous 1 month; Consumption of fermented foods (except yogurt), such as sour cream, acidophilus milk, kefir and some cheeses such as blue vein cheese or Swiss cheese in the previous 1 month; substance abuse; The compliance less than 80%.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences,Hemmat Highway, Tehran, Iran
City
Tehran
Postal code
Approval date
2016-11-19, 1395/08/29
Ethics committee reference number
IR.IUMS.REC 1395.9411468002

Health conditions studied

1

Description of health condition studied
Generalized anxiety disorder
ICD-10 code
F41.1
ICD-10 code description
Anxiety that is generalized and persistent but not restricted to, or even strongly predominating in, any particular environmental circumstances (i.e. it is "free-floating"). The dominant symptoms are variable but include complaints of persistent nervousne

Primary outcomes

1

Description
Symptom severity
Timepoint
at baseline, after 1 month and after 2 month
Method of measurement
Beck Anxiety Inventory, Hamilton Rating Scale for anxiety and State-Trait Anxiety Inventory questionnaires

2

Description
plasma acth
Timepoint
at baseline, after 1 month and after 2 month
Method of measurement
Electro-chemiluminescence immunoassay

3

Description
serum cortisol
Timepoint
at baseline, after 1 month and after 2 month
Method of measurement
Chemiluminescence immunoassay

4

Description
quality of life
Timepoint
at baseline, after 1 month and after 2 month
Method of measurement
quality of life, world health organization questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: sertraline plus probiotic supplement Contain Bifidobacterium Longom, Bifidobacterium bifidum, Bifidobacterium lactis, Lactobacillus acidophilus(18×109 CFU) and small amounts of fructooligosaccharides (a contributor to the growth and activity of microorganisms) daily after lunch for 8 weeks
Category
Treatment - Drugs

2

Description
control group: sertraline plus placebo capsule contains 220 mg starch, daily, after lunch for 8 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic of  Ziaeian Hospital
Full name of responsible person
Dr. Mohamad Effatpanah
Street address
Gazvin Sreet, Abouzar St, Clinic of  Ziaeian Hospital
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
Iran university of medical sciences,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
Iran University of Medical Sciences
Full name of responsible person
Sevda Eskandrazadeh
Position
Master student in nutrition sciences
Other areas of specialty/work
Street address
School of public health, Iran university of medical sciences,Hemmat Highway,Tehran, Iran
City
Tehran
Postal code
Phone
+98 912 072 8106
Fax
Email
sevda_eskandarzadeh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shima Jazayeri
Position
p.h.d (nutrition)
Other areas of specialty/work
Street address
School of public health, Iran university of medical sciences,Hemmat Highway,Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8670 4805
Fax
Email
jazayeri.sh@iums.ac.ir
Web page address

Person responsible for updating data

Contact

Sharing plan

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