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

To study the effects of synbiotics on antipsychotic induced weight gain: a randomized controlled trial - NIL

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/08/056889
Enrollment
140
Registered
2023-08-24
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

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

Interventions

Intervention1: oral probiotics plus prebiotics capsules: One group (Test) will be given one oral Synbiotic capsules daily with breakfast and one synbiotic capsule with dinner along with standard Antip

Sponsors

Government Medical College Patiala Punjab
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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 To evaluate the effects of Synbiotics as adjuvant treatment on lipid profile & fasting blood sugar in psychotic patients taking antipsychotics Timepoint: outcome will be assessed/estimated in four readings i.e. at baseline, 4 weeks ,8 weeks and 12 weeks

Secondary

MeasureTime frame
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

Countries

India

Contacts

Public ContactDr Mehtab Singh Bal

Government Medical College Patiala

drneetusharma1975@gmail.com9417075783

Outcome results

None listed

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