Effect of Probiotic Supplement on Insomnia in Patients with Substance-Induced Depressive Disorder

Effect of Probiotic Supplement on Insomnia in Patients with Substance-Induced Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190726044339N5

Enrollment

Registered

2025-12-15

Start date

2025-12-22

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

substance induced depressive disorder. Major depressive disorder, single episode

Interventions

Intervention 1: Intervention group: Intervention group: Participants will receive a daily probiotic supplement containing Lactobacillus helveticus and Bifidobacterium longum. Intervention 2: Control g

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: People aged between 18 and 70 years Suffering from insomnia and depression caused by substance use

Exclusion criteria

Exclusion criteria: Presence of serious and chronic diseases Pregnancy and breastfeeding Severe mental disorders Inability to comply with the study protocol

Design outcomes

Primary

Measure	Time frame
Insomnia severity. Timepoint: Before and after the four-week intervention period. Method of measurement: Pittsburgh Sleep Quality Index (PSQI) questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Hamdollah Mosavat

Shiraz University of Medical Sciences

hamdi_88114@yahoo.com+98 917 840 1495

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026