The aim of this study: Evaluation of the clinical effects of probiotics in social anxiety disorder of medical students of Shahrood city. Study design: After explaining the purpose of the study and obtaining the informed consent, patients will be allocated into A and B groups. The study is double blind, single-center, phase 3 trial. Inclusion criteria: Medical students of Shahrood city. Exclusion criteria: Documented liver or renal diseases; Routine use of probiotics. Sample size: 40 patients are participated in the study with 20 patients in each group. Intervention group: familact capsule 10 milion unit. Control group: starch capsule 3 gram. Primary outcome: decrease of social anxiety disorder.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017053034245N1
Registration date:2017-10-11, 1396/07/19
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-10-11, 1396/07/19
Registrant information
Name
Farhad Honarvar
Name of organization / entity
Islamic Azad University of Shahrood.
Country
Iran (Islamic Republic of)
Phone
+98 23 3223 3546
Email address
dr.farhadhonarvar@iau-shahrood.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2017-10-22, 1396/07/30
Expected recruitment end date
2018-01-20, 1396/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the clinical effects of probiotics in social anxiety disorder of medical students of Shahrood city
Public title
The effect of probiotics in social phobia of medical students
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Medical students of Shahrood city Exclusion criteria: Documented liver or renal diseases; Routine use of probiotics
Age
From 20 years old to 30 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
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 Islamic Azad University of Shahrood
Street address
Islamic Azad University of Shahrood, Tehran Blvd, Shahrood
City
Shahrood
Postal code
Approval date
2016-11-10, 1395/08/20
Ethics committee reference number
IR.IAU.SHAHROOD.REC.1395.6
Health conditions studied
1
Description of health condition studied
Social Phobia
ICD-10 code
F40.1
ICD-10 code description
Social phobias
Primary outcomes
1
Description
Social phobia disorder
Timepoint
First day of intervention and two days after the end of the intervention
Method of measurement
Conver's social phobia questionnaire
Secondary outcomes
1
Description
Depression
Timepoint
First day of intervention and two days after the end of intervention
Method of measurement
Beck's depression questionnaire
Intervention groups
1
Description
Intervention: Single dose of 10 milion CFU per each ML Familact probiotic capsule one hour after breakfast during 28 days
Category
Treatment - Drugs
2
Description
Control group: Single dose of 3 gram starch capsule one hour after breakfast during 28 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Medical School of Islamic Azad University Of Shahrood
Full name of responsible person
Fatemeh Amirkhalili
Street address
Medical School of Islamic Azad University Of Shahrood, Tehran Blvd, Shahrood
City
Shahrood
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research and Technology, Islamic Azad University of Shahrood
Full name of responsible person
Sahebali Manafi
Street address
21,Shahrdari street,Farhangian towndown,Shahrood City
City
Shahrood
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 and Technology, Islamic Azad University of Shahrood
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
Islamic Azad University of Shahrood
Full name of responsible person
Farhad Honarvar
Position
Medical Student
Other areas of specialty/work
Street address
Islamic Azad University of Shahrood, Tehran Blvd, Shahrood
City
Shahrood
Postal code
Phone
+98 23 3223 3546
Fax
Email
dr.farhadhonarvar@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University of Shahrood
Full name of responsible person
Fatemeh Amirkhalili
Position
General surgeon
Other areas of specialty/work
Street address
Islamic Azad University of Shahrood, Tehran Blvd, Shahrood
City
Shahrood
Postal code
Phone
+98 23 3239 0360
Fax
Email
amirkhalili.fatameh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University of Shahrood
Full name of responsible person
Farhad Honarvar
Position
Medical student
Other areas of specialty/work
Street address
Islamic Azad University of Shahrood, Tehran Blvd, Shahrood
City
Shahrood
Postal code
4318936199
Phone
+98 23 3223 3546
Fax
Email
dr.farhadhonarvar@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)