To study the effects of probiotics plus prebiotics on antipsychotic induced weight gain: a randomized controlled trial

Phase 4

Conditions: Health Condition 1: F20-F29- Schizophrenia, schizotypal, delusional, and other non-mood psychotic disorders

Registration Number: CTRI/2023/08/056889

Lead Sponsor: Government Medical College Patiala Punjab

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Adult patients taking antipsychotics and adjunct medication.

Patients diagnosed with schizophrenia spectrum and other psychotic disorders defined under DSM-5 (Diagnostic and statistical manual of mental disorders).

Patients of age group of 18-45 years.

Patients having = 5% weight gain after start of antipsychotics.

Exclusion Criteria

Patients who refuse to give consent for the use of study. o Patients already taking probiotic and prebiotic supplements. o Patients with diagnosed with gastrointestinal tract disorder.

Patients with history of metabolic or chronic medical illness like Diabetes Mellitus, Hypertension, Thyroid disorders etc.

Patients who are pregnant or planning to become pregnant during the study period.

Patients with history of substance use disorder.

Patients with history of antibiotic medication intake, 14 days prior to study (as anaerobic organisms residing in the gastrointestinal tract may be affected by antibiotics).

Patients who participated in any investigational drug trial in the past 30 days.

Patients not on any oral hypoglycemics or other weight lowering medication like Metformin, Topiramate etc.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the effects of use of oral Synbiotics in Antipsychotic induced weight gain in Schizophrenia Spectrum & other Psychotic Disorder patients as per DSM 5 Diagnostic & statistical manual of mental disorders <br/ ><br> To evaluate the effects of Synbiotics as adjuvant treatment on lipid profile & fasting blood sugar in psychotic patients taking antipsychotics <br/ ><br>Timepoint: outcome will be assessed/estimated in four readings i.e. at baseline, 4 weeks ,8 weeks and 12 weeks

Secondary Outcome Measures

Name	Time	Method
To compare BPRS (Brief Psychiatric Rating Scale ) Score in psychotic patients taking synbiotics & antipsychotics versus antipsychotics alone.Timepoint: outcome will be assessed/estimated in four readings i.e. at baseline, 4 weeks ,8 weeks & 12 weeks