A Study on the Effects of Lactobacillus fermentum 2L Probiotics on Reducing Stress and Fatigue

A 6-week, Multi-center, Randomilzed, Double-blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of Lacobacillus fermantum 2L probiotics on Stress and fatigue in the stressed adults

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0010580

Enrollment

Registered

2025-06-04

Start date

2025-07-17

Completion date

Unknown

Last updated

2026-01-05

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

Conditions

None listed

Interventions

Dietary Supplement : Product: Lactobacillus fermentum 2L (probiotic live bacteria) Form: Capsule containing pale yellow powder Dosage: 1 g/day (2 capsules/day), containing 1.0 × 108 CFU Frequency: On

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adults aged 19 years or older and younger than 65 years 2. Individuals experiencing moderate or higher levels of perceived stress based on the PSS-10 (Perceived Stress Scale-10) 3. Individuals who fully understand the purpose and procedures of the study and provide written informed consent voluntarily

Exclusion criteria

Exclusion criteria: 1. Individuals unable to read or understand the informed consent form 2. Individuals currently under treatment for severe physical illnesses, including cardiovascular, respiratory, gastrointestinal/hepatobiliary, renal/genitourinary, neurological, musculoskeletal, systemic, or infectious diseases 3. Individuals requiring long-term use of antibiotics 4. Individuals with a history of using antibiotics, prebiotics, or probiotics for more than 2 weeks within the past 3 months 5. Individuals currently diagnosed with a mental disorder according to DSM-5, or with moderate or greater substance use disorder within the past 6 months 6. Individuals with systemic diseases such as immunodeficiency, autoimmune disorders, or cancer 7. Pregnant or breastfeeding women

Design outcomes

Primary

Measure	Time frame
Change in total score of the Perceived Stress Scale-10 (PSS-10)	—

Secondary

Measure	Time frame
Depression Anxiety Stress Scale-21;Generalized Anxiety Disorder-7 ;Athens Insomnia Scale ;Brief Resilience Scale ;Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form ;Gastrointestinal Symptom Rating Scale;Heart rate variability;Fecal 16s rRNA ;Inflammatory Markers and Metabolomics	—

Countries

Korea, Republic of

Contacts

Public ContactChangsu Han

Korea University

shincm@korea.ac.kr+82-31-412-5130

Outcome results