Health Condition 1: G- Mental Health
Conditions
Interventions
Intervention1: Lactobacillus Plantarum: Lactobacillus Plantarum capsule
Dose - 1.2 billion Colony Forming Units per capsule
Frequency - 1 capsule per day
Duration- 4weeks
Route- Oral
Control Intervent
Sponsors
Central Institute of Psychiatry
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants satisfying the ICD 10-DCR [1993] criteria of unipolar depression (single/recurrent) 2. participants of either gender aged 8 to less than 18 years 3. Guardian giving written informed consent.
Exclusion criteria
Exclusion criteria: 1. Depressive episode with psychotic symptoms 2. Any other major co-morbid psychiatric diagnosis excluding anxiety disorder, dissociative disorder, adjustment disorders and substance dependence excluding nicotine& caffeine. 3. Presence of active suicidal ideations 4. Any current systemic infectionor inflammation or autoimmune disorders, currently using antibiotics, glucocorticoids and other probiotics, known hypersensitivity to probiotics. 5. Pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To study the effectiveness of adjunctive lactobacillus plantarum capsule in reducing the severity of depression compared to SSRIs alone at 2 weeks and end of 4 weeks.Timepoint: Baseline, 2weeks and 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To study the effect of lactobacillus plantarum on levels of IL-6, TNF-alpha and hs-CRP and correlate changes in depression severity with socio-demographic , clinical and laboratory parametersTimepoint: 2 weeks and 4weeks | — |
Countries
India
Contacts
Public ContactVarun S Mehta
Central Institute of Psychiatry
Outcome results
None listed