Skip to content

Use of probiotics in the treatment of schizophrenia

Role of Probiotics & Metabolic response in Schizophrenia- A Randomised double blind placebo controlled study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/06/042960
Enrollment
100
Registered
2022-06-01
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

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

Conditions

Health Condition 1: F200- Paranoid schizophrenia

Interventions

Intervention1: Probiotics: Probiotic blend 10 billion CFU, L- glutamine 250mg.Available in sachet form. Route of administration - oral. Each patient will be given 2 sachet per day for 12 weeks. Contro

Sponsors

VIBRONICA A Division of Kepler heathcare Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients aged 18-45 years. 2.ICD -10 diagnosis of schizophrenia any type or schizoaffective disorder with disease duration of atleast 2 years. 3.Willing to participate in the study 4.Education of 9th std and above 5.Scores on the Positive and Negative Syndrome Scale (PANSS) indicative of at least moderately severe psychosis, total PANSS score >= 50. 6.Cognitive deficit below 15th percentile in any one cognitive domain of NIMHANS battery.

Exclusion criteria

Exclusion criteria: 1.Patients who are uncooperative due to the severity of the illness. 2.Existence of serious medical/neurological disorder, known allergic to Probiotics. 3.Patients with diagnosis of mental retardation. 4.Primary diagnosis of substance abuse or dependence within the last 3 months. participated in any investigational drug trial in the past 30 days; 5.Women who were currently pregnant, planning to get pregnant /breastfeeding. Not consenting to participate in the study.

Design outcomes

Primary

MeasureTime frame
fasting serum insulin, insulin resistance, body mass index, fasting blood glucose, lipid profile and body weightTimepoint: baseline and 12 weeks

Secondary

MeasureTime frame
PANSS scores cognitive symptoms (executive function, attention and memory)Timepoint: baseline, 4 ,8 and 12 weeks.

Countries

India

Contacts

Public ContactHema Tharoor

Schizophrenia Research Foundation

hematharror@scarfindia.org04426151073

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026