The effectiveness of probiotics versus placebo as an add on treatment to standard treatment in out patients with newly diagnosed depressive episodes at the psychiatry out patients clinics at Teaching Hospital Peradeniya

Effectiveness of probiotics as an adjunct to standard treatment among newly diagnosed patients requiring treatment for depression : A double blind randomized control trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2025/016

Enrollment

Unknown

Registered

2025-04-23

Start date

2025-04-28

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Depression

Interventions

Study setting: Out Patients Department at Teaching Hospital Peradeniya Randomization method: Block randomization Intervention: Participants will receive the probiotic in capsule form to be taken on

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with the first episode of depression at the clinic visit as mild, moderate or severe depression, with or without psychotic symptoms 2. Male and female patients 3. Age 18 years or more

Exclusion criteria

Exclusion criteria: 1.History of a past episode of depression at any point of time 2.History of a single manic episode or bipolar disorder 3.History of, or current eating disorders 4.Personality disorders 5.Serious medical illness, gastrointestinal disease or surgery 6 Current or regular gastrointestinal medication 7. Pregnancy or breastfeeding 8. Co morbid substance use disorder amounting to dependence 9. Co morbid diagnosis of schizophrenia or dementia 10. Being on probiotics at the time of the study or the past 12 weeks 11. Being on antibiotics at the time of the study 12. Adverse reactions to products containing probiotics in the past

Design outcomes

Primary

Measure	Time frame
Clinical severity of depression as scored on the Becks Depression Inventory [On day one and monthly for a total of 6 months]	—

Secondary

Measure	Time frame
Score on the Life Change Index Scale (The Stress Test) [On day one and monthly for a total of 6 months]	—

Countries

Sri Lanka

Contacts

Public ContactDr Sayuri Perera

Senior Lecturer and Consultant Psychiatrist

sayuperera@yahoo.com0812396000

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 10, 2026