Protocol summary
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Study aim
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The Effect of Symbiotic Supplementation on the Components of Metabolic Syndrome in Schizophrenia Patients
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Design
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A randomized, double-blind, parallel design trial with one intervention and one control group
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Settings and conduct
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After obtaining consent, patients were randomly divided into two groups: taking symbiotic supplements (1 g daily) and controls (placebo with similar specifications). Patients receive supplementation for 8 weeks. Placebo and supplements are coded by someone other than the researcher. Participants and the lead researcher will not be informed of supplement and placebo content. At the beginning and end of the study, 10 cc blood samples will be taken to measure biochemical factors.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: 1. Having at least 2 metabolic syndrome criteria 2. Age range 18-65 years 3. Willingness to cooperate 4. suffering schizophrenia for at least 1 year 5.BMI≥23
6. Disease of schizophrenia according to DSM-V criteria
Inclusion criteria: 1. Endocrine disorders 2. Weight loss medications, Corticosteroids over 10 days 3. History of weight loss surgeries 4. Any conditions that the researcher does not consider appropriate for the study 5. Drug abuse 6. Immune deficiency 7. Pregnant and lactating mothers and women of childbearing age 8. Female participants who plan to become pregnant 9. Change in dosage and type of medication at least 2 months prior to intervention 10. Antibiotic use from 1 month before study 11. Consumption Foods containing symbiotic, prebiotic and probiotic 1 month before intervention
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Intervention groups
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70 people with schizophrenia will be included in the study according to inclusion criteria. Subjects were randomly divided into two intervention groups (probiotic or placebo)
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Main outcome variables
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Waist circumference, fasting blood sugar, total cholesterol, high density lipoprotein, triglyceride, hypertension
General information
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Reason for update
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Two inclusion criteria were corrected because they could not affect the study outcomes. (PANSS and duration of the disease)
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20090901002394N45
Registration date:
2019-12-26, 1398/10/05
Registration timing:
registered_while_recruiting
Last update:
2023-10-15, 1402/07/23
Update count:
2
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Registration date
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2019-12-26, 1398/10/05
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-11-11, 1398/08/20
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Expected recruitment end date
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2020-06-09, 1399/03/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effects of Synbiotics on the Components of Metabolic Syndrome in Patients with Schizophrenia
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Public title
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Effects of Synbiotics on the Components of Metabolic Syndrome in Patients with Schizophrenia
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Purpose
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Health service research
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Inclusion/Exclusion criteria
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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)
Outpatient
Duration of illness more than one year
BMI ≥ 23
Exclusion criteria:
Pregnancy and lactation
A history of drug or alcohol dependence or abuse
Diagnosis of mental retardation
Diagnosis of neurological disease or any serious illness that needs treatment
Diagnosis of major gastrointestinal, renal, heart, cancer, HIV infection or other immunodeficiency problems
Having a history of traumatic brain injury, seizures, epilepsy, Loss of consciousness (LOC) for more than 30 minutes, or other known neurological or organic diseases of the central nervous system
Having suicidal or homicidal thoughts or any safety concern by research staff
Sensitivity to probiotics, prebiotic and synbiotic
Subjects who may require imminent hospitalization
Change the Dose and type of medication used during the last 2 months
Receive of electricity shock treatment, immunosuppressive medications, stimulants, mood stabilizer during the last 3 months
Receive of Antibiotics in the last month
Consumption of Food or supplements containing probiotics, prebiotic and synbiotic over the last month such as kefir-yogurt-cheese and ...
Consumption of dietary supplements in the last month
Any disease or condition in which the researcher does not consider the participants appropriate for the study
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
70
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients will be divided into two groups receiving two daily synbiotic capsules or placebo after coding using random codes. Random allocation will be performed using four blocks classified by BMI and gender.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In order to double-blind the study of total cans containing capsules by a person other than the researcher, they will be divided into two groups in order to observe the researcher not knowing the type of capsules received by each group. Researcher, statistical consultant, and physician unaware of this classification This classification will be based on a random number table
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-11-20, 1397/08/29
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Ethics committee reference number
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IR.IUMS.REC.1398.650
Health conditions studied
1
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Description of health condition studied
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schizophrenia
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ICD-10 code
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F20
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ICD-10 code description
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Schizophrenia
Primary outcomes
1
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Description
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Waist circumference
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Timepoint
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8 weeks
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Method of measurement
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Tape measure
2
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Description
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Fasting blood sugar
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Timepoint
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8 weeks
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Method of measurement
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Enzymatic colorimetric
3
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Description
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Total cholesterol
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Timepoint
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8 weeks
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Method of measurement
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Enzymatic colorimetric
4
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Description
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HDL
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Timepoint
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8 weeks
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Method of measurement
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Enzymatic colorimetric
5
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Description
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TG
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Timepoint
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8 weeks
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Method of measurement
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Enzymatic colorimetric
6
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Description
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blood pressure
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Timepoint
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8 weeks
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Method of measurement
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Mercury barometer
Secondary outcomes
1
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Description
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LDL
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Timepoint
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8 weeks
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Method of measurement
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Enzymatic colorimetric
2
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Description
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Serum insulin
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Timepoint
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8 weeks
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Method of measurement
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Eliza
3
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Description
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HOMA-IR
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Timepoint
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8 weeks
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Method of measurement
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Calculation by formula
4
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Description
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QUICKI
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Timepoint
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8 weeks
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Method of measurement
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Calculation by formula
5
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Description
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HbA1c
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Timepoint
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8 weeks
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Method of measurement
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analyzer
6
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Description
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hs-CRP
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Timepoint
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8 weeks
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Method of measurement
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Eliza
7
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Description
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Weight
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Timepoint
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8 weeks
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Method of measurement
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Standard scales
8
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Description
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BMI
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Timepoint
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8 weeks
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Method of measurement
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Calculation measured by height and weight
Intervention groups
1
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Description
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Intervention group: 2 capsules of 500mg Lactocare daily for 8weeks
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Category
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Treatment - Other
2
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Description
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Control group: Take 2 placebo capsules daily for 8 weeks
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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100%
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no more information
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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There is no more information
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When the data will become available and for how long
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There is no more information
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To whom data/document is available
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There is no more information
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Under which criteria data/document could be used
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There is no more information
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From where data/document is obtainable
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There is no more information
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What processes are involved for a request to access data/document
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There is no more information
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Comments
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