| CTRI Number |
CTRI/2025/09/095305 [Registered on: 23/09/2025] Trial Registered Prospectively |
| Last Modified On: |
13/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Investigating the Effects of Probiotics on Memory and Thinking in Schizophrenia: A Study on Brain and Metabolic Health |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shlok nagil |
| Designation |
Junior resident, Psychiatry |
| Affiliation |
Central Institute of Psychiatry, Ranchi, Kanke, Ranchi, Jharkhand |
| Address |
Central Institute of Psychiatry , Ranchi , Jharkhand , Pin - 834006
Ranchi
JHARKHAND
834006
India |
| Phone |
8319767940 |
| Fax |
|
| Email |
Shlok.nagil111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunilkumar RSuryavanshi |
| Designation |
Professor of Psychiatry |
| Affiliation |
CENTRAL INSTITUTE OF PSYCHIATRY ,RANCHI |
| Address |
Central Institute of Psychiatry , Ranchi ,Jharkhand
Central Institute Of Psychiatry , Ranchi , Jharkhand
Ranchi
JHARKHAND
834006
India |
| Phone |
8007774822 |
| Fax |
|
| Email |
Sunilsuryavanshi5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunilkumar RSuryavanshi |
| Designation |
Professor of Psychiatry |
| Affiliation |
Central institute of Psychiatry,Ranchi |
| Address |
Central Institute of Psychaitry ,Ranchi , Jharkhand
Central Institute of Psychiatry , Ranchi , Jharkhand
JHARKHAND
834006
India |
| Phone |
8007774822 |
| Fax |
|
| Email |
Sunilsuryavanshi5@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central institute of psychiatry,Ranchi,Jharkhand,India,Pin- 834006 |
|
|
Primary Sponsor
|
| Name |
Central institute of Psychiatry ,Ranchi |
| Address |
Central Institute of Psychiatry,kankee ,Ranchi 834006,Jharkhand |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shlok Nagil |
Central Institute of Psychiatry |
Department of Biochemistry and Pathology ,Central Institute of Psychiatry
kanke Ranchi 834006 Jharkhand
Ranchi
JHARKHAND |
8319767940
shlok.nagil111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE,CIP RANCHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F20||Schizophrenia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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 to treatment as usual with a stable dose of antipsychotics. |
| Comparator Agent |
Placebo capsule (1 capsule/day) as adjunct to treatment as usual for duration of 4 weeks. |
The comparator group will receive a placebo capsule once daily for 4 weeks, in addition to treatment as usual with a stable dose of antipsychotics. The placebo capsule will be visually identical to the probiotic capsule but will not contain any probiotic strains or L-glutamine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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).
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Outcome: Change in cognitive function scores measured by Hindi Montreal Cognitive Assessment (MoCA) from baseline to 4 weeks between probiotic and placebo groups.
|
Time Points: Baseline, 2 weeks, and 4 weeks.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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).
|
Time Points: Baseline, 2 weeks, and 4 weeks. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
04/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
the group 1 (25 patients) receive probiotics and the group 2 (25 patients) receive placebo for 4 weeks .then both groups will be evaluated on PANSS,MOCA, SERUM IL6,BDNF,hsCRP,FBS,BMI,Triglyceride at baseline.this will be repeated with the application of SAFTEE at 2 weeks and 3 weeks |