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Investigating the Effects of Probiotics on Memory and Thinking in Schizophrenia: A Study on Brain and Metabolic Health

Probiotics as an adjunctive therapy in cognitive symptoms of Schizophrenia and its correlation with serum biomarkers and metabolic profile : A double-blind randomized placebo controlled study - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/095305
Enrollment
50
Registered
2025-09-23
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Health Condition 1: F20- Schizophrenia

Interventions

Intervention1: Probiotic capsule (1 capsule/day) as adjunct to treatment as usual for duration of 4 weeks: The intervention group will receive a probiotic capsule once daily for 4 weeks, in addition t

Sponsors

Central institute of Psychiatry ,Ranchi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Participants satisfying the ICD 10-DCR [1993] criteria of schizophrenia 2. Age 18 - 60 years of both sexes. 3. Illness duration of equal to or more than 2 years 4. Patient giving written informed consent. 5. Score between 18 to 25 on screening with Hindi Montreal Cognitive Assessment Test (Hindi MoCA).

Exclusion criteria

Exclusion criteria: 1. Any other major co-morbid psychiatric diagnosis excluding anxiety disorder, dissociative disorder, adjustment disorders and substance dependence excluding nicotine& caffeine. 2. Presence of any medical,surgical and psychiatric emergency. 3. Any current systemic infection or inflammation or autoimmune disorders, currently using antibiotics, glucocorticoids and other probiotics, known hypersensitivity to probiotics.

Design outcomes

Primary

MeasureTime frame
Outcome: Change in cognitive function scores measured by Hindi Montreal Cognitive Assessment (MoCA) from baseline to 4 weeks between probiotic and placebo groups. Timepoint: Time Points: Baseline, 2 weeks, and 4 weeks.

Secondary

MeasureTime frame
Change in serum IL-6, hs-CRP, and BDNF levels. Change in BMI, fasting plasma glucose, and triglyceride levels. Change in PANSS scores. Adverse events (SAFTEE). Timepoint: Time Points: Baseline, 2 weeks, and 4 weeks.

Countries

India

Contacts

Public ContactDr Sunilkumar RSuryavanshi

CENTRAL INSTITUTE OF PSYCHIATRY ,RANCHI

Sunilsuryavanshi5@gmail.com8007774822

Outcome results

None listed

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