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The effect of probiotic supplementation on treatment of resistant depression in people over 60 years old

The effect of probiotic supplementation on treatment of resistant depression in people over 60 years old

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250531065998N1
Enrollment
56
Registered
2025-06-16
Start date
2025-06-22
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Treatment resistant depression. Major depressive disorder, recurrent

Interventions

Intervention 1: Intervention group: Probiotic substance Geri Lact, a substance consisting of 7 bacterial strains in capsule form and produced by Zist Takhmir Company, which patients consume one capsul

Sponsors

Kashan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: Over 60 years old Obtaining a score above 14 on the Beck Depression Inventory 2 Education at the end of primary school

Exclusion criteria

Exclusion criteria: Having a mental disorder other than depression Dementia Having a plan to commit suicide Received psychotherapy in the past 12 months Drug and food sensitivity Having physical illnesses such as immune system deficiencies Taking immunosuppressive drugs and chemotherapy Active intestinal diseases Symptoms of infection Reluctance to cooperate Taking dietary supplements containing probiotics, such as probiotic dairy products and taking omega-3 and multivitamin-mineral supplements

Design outcomes

Primary

MeasureTime frame
Depression score on the Beck 2 Depression Inventory. Timepoint: Before the start of the intervention and 56 days after the start of the intervention. Method of measurement: Beck 2 depression questionnaire.

Secondary

MeasureTime frame
Depression total score. Timepoint: Before the intervention begins and after the intervention ends. Method of measurement: Score from the Beck questionnaire.;Social functioning score. Timepoint: Before the intervention begins and after the intervention ends. Method of measurement: Average score of items related to social functioning of the Beck2 questionnaire.;Average recognition score. Timepoint: Before the intervention begins and after the intervention ends. Method of measurement: Average score of items related to cognition in the Beck 2 questionnaire.;Average emotion score. Timepoint: Before the intervention begins and after the intervention ends. Method of measurement: Average score of items related to emotion in the Beck Questionnaire 2.;Average physical score. Timepoint: Before the intervention begins and after the intervention ends. Method of measurement: Average score of physical items of the Beck Questionnaire 2.;Average score of overt behaviors. Timepoint: Before the intervention begins and after the intervention ends. Method of measurement: Average score of items related to overt behaviors of the Beck Questionnaire 2.;Severity of depression. Timepoint: Before the intervention begins and after the intervention ends. Method of measurement: Average depression severity score based on Beck Depression Inventory 2.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahboubeh Alsadat Tavalaei Zavareh

Kashan University of Medical Sciences

m.tavalaei100@yahoo.com+98 31 5437 3432

Outcome results

None listed

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