The aim of this study: Evaluation of the effects of probiotics on general mental health in healthy human volunteers of Shahrood city. Study design: After explaining the purpose of the study and obtaining the informed consent, people will be allocated into A and B groups. The study is double blind, single-center, phase 3 trial. Inclusion criteria: Informed consent. Exclusion criteria: Diabetes; cardiovascular diseases; gastrointestinal diseases; routine use of probiotics. Sample size: 50 people are participated in the study with 25 people in each group. Intervention group: Familact probiotic capsule 10 milion unit oral. Control group: Starch capsule 3 gram oral. Primary outcome: Improve general mental health.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017053034246N1
Registration date:2017-10-10, 1396/07/18
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-10-10, 1396/07/18
Registrant information
Name
Hadi Sasani
Name of organization / entity
Islamic Azad University Of Shahrood
Country
Iran (Islamic Republic of)
Phone
+98 17 3522 9652
Email address
doctor.hadi.sasani@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
2017-12-21, 1396/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of probiotics on general mental health in healthy human volunteers of Shahrood city
Public title
Effect of probiotics on general mental health in healthy human volunteers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Informed consent Exclusion criteria: Diabetes; cardiovascular diseases; gastrointestinal diseases; routine use of probiotics
Age
From 21 years old to 50 years old
Gender
Both
Phase
3
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 Islamic Azad University of Shahrood
Street address
Islamic Azad University of Shahrood, Tehran Blvd, Shahrood City
City
Shahrood
Postal code
Approval date
2016-11-10, 1395/08/20
Ethics committee reference number
IR.IAU.SHAHROOD.REC.1395.7
Health conditions studied
1
Description of health condition studied
General mental health
ICD-10 code
R46.8
ICD-10 code description
Other symptoms and signs involving appearance and behaviour
2
Description of health condition studied
Generalized anxiety disorder
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
General mental health
Timepoint
Before intervention and one day after intervention
Method of measurement
Goldberg's general mental health questionnaire
Secondary outcomes
1
Description
Generelized anxiety disorder
Timepoint
One day before intervention, on day after intervention
Method of measurement
Goldberg's general mental health questionnaire
Intervention groups
1
Description
Intervention: Single dose of 10 million unit familact probiotic capsule after breakfast 28 days
Category
Treatment - Drugs
2
Description
Control: Single dose of 3 gram placebo starch capsule after breakfast 28 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam Alanbia Hospital of Shahrood
Full name of responsible person
Fatemeh Amirkhlili
Street address
Khatam Alanbia Hospital of Shahrood, Tehran Blvd, Shahrood
City
Shahrood
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research and Technology
Full name of responsible person
Sahebali Manafi
Street address
Islamic Azad University of Shahrood, Tehran Blvd, Shahrood
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
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
Hadi Sasani
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 3239 0360
Fax
Email
doctor.hadi.sasanii@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
4318936199
Phone
+98 32 3223 3546
Fax
Email
dr.fatemehamirkhalili@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University of Shahrood
Full name of responsible person
Hadi Sasani
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 3222 0611
Fax
Email
doctor.hadi.sasanii@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)