Effect of symbiotic supplementation on symptoms and brain-derived neurotrophic factor (BDNF) in Schizophrenia Patients
Design
double blind randomized controlled trial
Settings and conduct
Patients with schizophrenia 18-65 years old referred to psychiatric hospital of Iran and randomly divided into intervention or placebo groups (8 weeks). To measure serum BDNF levels, 10 ml of venous blood is collected after 10-12 hours of fasting at the beginning and end of the study. An evaluation of the symptoms of schizophrenia from the PANSS scale will also be performed at the beginning and end of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:1-Willingness to collaborate 2-Complete the informed consent form by the patient and the patient's guardian 3-Age range 18-65 years 4- Schizophrenia according to DSM-V criteria 5- Patients with PANSS total score ≥ 50 6-Outpatient 7-Duration of illness less than 6 years 8-BMI ≥ 23
Exclusion criteria:1-Pregnancy and lactation 2-A history of drug or alcohol dependence or abuse 3-Diagnosis of mental retardation 4-Diagnosis of major gastrointestinal, renal, heart, cancer, HIV infection ,neurological disease or other immunodeficiency problems 5-Having suicidal or homicidal thoughts 6-Sensitivity to probiotics, prebiotic and synbiotic 7-Change the Dose and type of medication used during the last 2 months 8-Receive of Antibiotics in the last month 9-Consumption of probiotics, prebiotic or synbiotic over the last month 10-Consumption of dietary supplements in the last month
Intervention groups
Intervention group: 2 daily 500 mg capsules of Lactocar Control group: 2 daily 500 mg placebo capsules
Main outcome variables
Symptoms of schizophrenia؛ Brain-derived neurotrophic factor
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090901002394N46
Registration date:2019-12-27, 1398/10/06
Registration timing:registered_while_recruiting
Last update:2019-12-27, 1398/10/06
Update count:0
Registration date
2019-12-27, 1398/10/06
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
Expected recruitment start date
2019-11-27, 1398/09/06
Expected recruitment end date
2020-06-09, 1399/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Synbiotic Supplementation on Symptoms and Brain-derived neurotrophic factor (BDNF) in patients with Schizophrenia
Public title
Effect of Synbiotic Supplementation on schizophrenia symptoms
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to collaborate
Complete the informed consent form by the patient and the patient's guardian
Age range 18-65 years
Schizophrenia according to DSM-V criteria (By a psychiatrist)
Patients with PANSS total score ≥ 50
Outpatient
Duration of illness less than 6 years
BMI ≥ 23
Exclusion criteria:
Pregnancy and lactation
A history of drug or alcohol dependence or abuse
Diagnosis of mental retardation
Diagnosis of major gastrointestinal, renal, heart, cancer, HIV infection ,neurological disease or other immunodeficiency problems
Having suicidal or homicidal thoughts
Sensitivity to probiotics, prebiotic and synbiotic
Change the Dose and type of medication used during the last 2 months
Receive of Antibiotics in the last month
Consumption of probiotics, prebiotic or synbiotic over the last month
Consumption of dietary supplements in the last month
Age
From 18 years old to 65 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
Subjects will be divided into intervention and placebo groups by stratified randomization based on sex and BMI using 4-sided permutation blocks and randomly selected blocks based on random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo and supplements are similar in appearance And someone other than the researcher encodes them. All investigators, study staff, and participants will be unaware of the allocations
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee, Iran University of Medical Sciences
Street address
Shahid Hemmat Highway, next to Milad Hospital, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2019-10-02, 1398/07/10
Ethics committee reference number
IR.IUMS.REC.1398.708
Health conditions studied
1
Description of health condition studied
schizophrenia
ICD-10 code
F20-F29
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Symptoms of schizophrenia
Timepoint
at baseline, and after 2 month
Method of measurement
PANSS scale
2
Description
Brain-derived neurotrophic factor
Timepoint
at baseline, and after 2 month
Method of measurement
Eliza
Secondary outcomes
1
Description
Anxiety and Depression Function
Timepoint
at baseline, and after 2 month
Method of measurement
Hospital Anxiety and Depression Scale
2
Description
Gastrointestinal symptoms
Timepoint
at baseline, and after 2 month
Method of measurement
GSRS Scale
3
Description
physical activity
Timepoint
beginning and end of intervention
Method of measurement
IPAQ questionnaire
4
Description
energy intake
Timepoint
beginning and end of intervention
Method of measurement
24-hour food recall questionnaire
Intervention groups
1
Description
Intervention group: 2 capsules of 500mg Lactocare daily for 8weeks
Category
Treatment - Other
2
Description
Control group: Take 2 placebo capsules daily for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran Psychiatric Hospital
Full name of responsible person
Dr. Fatemeh Hadi
Street address
Hemmat Highway, between the intersection of Sheikh Fazlollah noori and Chamran, next to the Milad Hospital, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4805
Email
ccssoommaa@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Abbas Motevallian
Street address
Hemmat Highway, between the intersection of Sheikh Fazlollah noori and Chamran, next to the Milad Hospital, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
motevalian@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Somayeh Jamali paghaleh
Position
Master student in nutrition sciences
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Hemmat Highway, between the intersection of Sheikh Fazlollah noori and Chamran, next to the Milad Hospital, Iran University of Medical Sciences
City
tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4805
Email
ccssoommaa@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr shima jazayeri
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
school of public health, Iran university of medical sciences, Hemmat highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4805
Email
sh_jazayeri@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Somayeh Jamali paghaleh
Position
Master student in nutrition sciences
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Hemmat Highway, between the intersection of Sheikh Fazlollah noori and Chamran, next to the Milad Hospital, Iran University of Medical Sciences
City
tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4805
Email
ccssoommaa@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
No - There is not 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
Yes - There is 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
Title and more details about the data/document
There is no more information
When the data will become available and for how long
There is no more information
To whom data/document is available
There is no more information
Under which criteria data/document could be used
There is no more information
From where data/document is obtainable
There is no more information
What processes are involved for a request to access data/document