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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20090901002394N45
Enrollment
70
Registered
2019-12-26
Start date
2019-11-11
Completion date
Unknown
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

schizophrenia. Schizophrenia

Interventions

Intervention 1: Intervention group: 2 capsules of 500mg Lactocare daily for 8weeks. Intervention 2: Control group: Take 2 placebo capsules daily for 8 weeks.

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion 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) Outpatient Duration of illness more than one year BMI = 23

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
LDL. 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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactPoorya Basafaroodi

Iran University of Medical Sciences

samanbasafa82@rocketmail.com+98 21 8670 4805

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 5, 2026