Effect of supplementation in treatment of schizophrenia patients

Clinical trial of the effect of combined probiotic and vitamin D supplementation compared with the placebo on Clinical symptom and metabolic profiles in schizophrenia patients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017072333551N2

Enrollment

Registered

2017-07-31

Start date

2017-05-04

Completion date

Unknown

Last updated

2019-10-07

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: Combined probiotic, including 2×109 Lactobacillus acidophilus, 2×109 Bifidobacterium bifidum, 2×109 Lactobacillus reuteri, 2×109 Lactobacillus fermentum daily, and

Eligibility

Sex/Gender

All

Age

25 Years to 65 Years

Inclusion criteria

Inclusion criteria: Diagnosed with schizophrenia using DSM-IV-TR criteria PANSS score of 55 or greater Treated with chlorpromazine (300–1000mg/day, except clozapine) and agents anti-cholinergic (Trihexyphenidyl, 4–8 mg/day) during the last 6 months Aged 25–65 years old Disease duration of at least two years

Exclusion criteria

Exclusion criteria: Mental retardation Substance or alcohol addiction (except caffeine or nicotine) with in the last 6 months of screening A score of=14 on a 17-item Hamilton Depression Rating Scale or a score of =4 on PANSS (depression item) Under treatment with lithium, carbamazepine and sodium valproic acid Existing chronic and acute medical illness Lactation or pregnancy The use of anti-depressants including MAO, TCA, SSRI in the last 6 months

Design outcomes

Primary

Measure	Time frame
Positive and Negative Syndrome Scale(PANSS). Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Clinical Examination.	—

Secondary

Measure	Time frame
Fasting plasma glucose. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;HDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Total antioxidant. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.	—

Measure

Time frame

Fasting plasma glucose. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;HDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Total antioxidant. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZatollah Asemi

Kashan University of Medical Sciences

asemi_z@kaums.ac.ir+98 31 5546 3378

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 22, 2026