MedPath

Effects of Synbiotics on the Components of Metabolic Syndrome in Patients with Schizophrenia

Phase 3
Conditions
schizophrenia.
Schizophrenia
Registration Number
IRCT20090901002394N45
Lead Sponsor
Iran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
70
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

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Waist circumference. Timepoint: 8 weeks. Method of measurement: Tape measure.;Fasting blood sugar. Timepoint: 8 weeks. Method of measurement: Enzymatic colorimetric.;Total cholesterol. Timepoint: 8 weeks. Method of measurement: Enzymatic colorimetric.;HDL. Timepoint: 8 weeks. Method of measurement: Enzymatic colorimetric.;TG. Timepoint: 8 weeks. Method of measurement: Enzymatic colorimetric.;Blood pressure. Timepoint: 8 weeks. Method of measurement: Mercury barometer.
Secondary Outcome Measures
NameTimeMethod
DL. Timepoint: 8 weeks. Method of measurement: Enzymatic colorimetric.;Serum insulin. Timepoint: 8 weeks. Method of measurement: Eliza.;HOMA-IR. Timepoint: 8 weeks. Method of measurement: Calculation by formula.;QUICKI. Timepoint: 8 weeks. Method of measurement: Calculation by formula.;HbA1c. Timepoint: 8 weeks. Method of measurement: analyzer.;Hs-CRP. Timepoint: 8 weeks. Method of measurement: Eliza.;Weight. Timepoint: 8 weeks. Method of measurement: Standard scales.;BMI. Timepoint: 8 weeks. Method of measurement: Calculation measured by height and weight.
© Copyright 2025. All Rights Reserved by MedPath