A clinical trial to study the effect of Probiotics in patients with Major Depressive Disorder

Probiotics as an add-on in Major Depressive Disorder

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/05/025027

Enrollment

100

Registered

2020-05-05

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: F322- Major depressive disorder, singleepisode, severe without psychotic features

Interventions

Intervention1: Standarad of care of depression along with Capsule Sporolac plus: one probiotic Sporolac plus capsule, containing probiotic not less than 2.5 billion cells of Lactobacillus acidophilus(

Eligibility

Inclusion criteria

Inclusion criteria: 1. The patients with a diagnosis of Major Depressive Disorder according to DSM-5 criteria presenting to Department of Psychiatry in DMC&H, Ludhiana. 2. Age group between 18-65 years. 3. Patients who have agreed upon no changes in their routine physical activity and dietary intake throughout the study.

Exclusion criteria

Exclusion criteria: 1.Any other major psychiatric disorder in patients of Major Depressive Disorder. 2.Regular intake of probiotics during last 2 months before recruitment for the study. 3.History of any renal, hepatic, cardiovascular or respiratory disease in the patient. 4.Intake of antioxidant or omega 3 supplements less than 6weeks before beginning of study. 5.Female patients currently having pregnancy and lactation. 6.Any type of substance abuse in the patient. 7.Patients with history of heart attack and stroke following a specific diet. 8.Patients with intake of antibiotics 2 weeks before the study or during study. 9.Immunocompromised patients. 10.Patients who have not given consent for the study.

Design outcomes

Primary

Measure	Time frame
In this study, the primary outcome will be assessed on Mini International Neuropsychiatric Interview (M.I.N.I.), Hamilton Depression Rating Scale (HAM-D), Montgomery Asberg Depression Rating Scale(MADRS). Depressed mood will be judged in the beginning at 0 week, after 3 weeks and at the end of study at 6 weeks and the scores will be compared.Timepoint: In this study, the primary outcome will be assessed on Mini International Neuropsychiatric Interview (M.I.N.I.), Hamilton Depression Rating Scale (HAM-D), Montgomery Asberg Depression Rating Scale(MADRS). Depressed mood will be judged in the beginning at 0 week, after 3 weeks and at the end of study at 6 weeks and the scores will be compared.	—

Measure

Time frame

In this study, the primary outcome will be assessed on Mini International Neuropsychiatric Interview (M.I.N.I.), Hamilton Depression Rating Scale (HAM-D), Montgomery Asberg Depression Rating Scale(MADRS). Depressed mood will be judged in the beginning at 0 week, after 3 weeks and at the end of study at 6 weeks and the scores will be compared.Timepoint: In this study, the primary outcome will be assessed on Mini International Neuropsychiatric Interview (M.I.N.I.), Hamilton Depression Rating Scale (HAM-D), Montgomery Asberg Depression Rating Scale(MADRS). Depressed mood will be judged in the beginning at 0 week, after 3 weeks and at the end of study at 6 weeks and the scores will be compared.

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Secondary

Measure	Time frame
study of adverse drug reactionsTimepoint: 0,3,6 weeks	—

Countries

India

Contacts

Public ContactDeepika Bansal

Baba Farid University of Health Sciences, Faridkot, Punjab

ranjive@gmail.com9872655006

Outcome results

None listed

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