The effect of probiotic supplement on depression severity

Effect of probiotic supplement on depression severity, plasma BDNF (brain drived neurotrophic factor), Cortisol & ACTH (adernocorticotropic hormon) in major depressive disorder patient

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201601102394N20

Enrollment

Registered

2016-03-05

Start date

2015-12-22

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Depression. Depressive episode

Interventions

Intervention 1: Control, Placebo. Intervention 2: Intervention, Multi species probiotic capsules containing Lactobacillus helveticus, Bifidbacterium longum.

Placebo

Treatment - Drugs

Control, Placebo

Intervention, Multi species probiotic capsules containing Lactobacillus helveticus, Bifidbacterium longum

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Patients with major depressive according to DSM-IV-TR criteria that they have not use any supplement and antidepressant drug at least 2 months prior to the start of the project; aged 18 to 65 years; at least score 15 on Hamilton Depression Rating Scale 17 (HDRS-17). Exclusion Criteria: Pregnancy and lactation; drug abuse within 6 months prior to the start of the project; psychosis; any type of severe chronic physical illness and any extreme and severe mental disorders (suicidal ideation, psychotic symptoms, symptoms of manic phase, etc)

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Depression severity. Timepoint: begining, end of forth week, end of intervention. Method of measurement: Hamilton Depression Rating Scale.;BDNF. Timepoint: begining, end of intervention. Method of measurement: ELIZA.;Cortisol. Timepoint: begining, end of intervention. Method of measurement: ELIZA.;ACTH. Timepoint: begining, end of intervention. Method of measurement: electrocemiLuminescence.	—

Secondary

Measure	Time frame
Side effect. Timepoint: end of forth week, end of intervention. Method of measurement: side effect questionnaire.;Energy intake. Timepoint: begining, end of intervention. Method of measurement: 24-hour recall.;Physical activity. Timepoint: begining, end of intervention. Method of measurement: IPAQ questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Shima Jazayeri

Iran University of Medical Sciences

sh_jaz@yahoo.com+98 21 8670 4805

Outcome results

None listed

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