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Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy of probiotic on mood states

Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy of probiotic on mood states - Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy of probiotic on mood states

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000045231
Enrollment
30
Registered
2021-09-14
Start date
2021-09-15
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

None

Interventions

Intake of powdered probiotic for 6 weeks Intake of powdered placebo for 6 weeks

Sponsors

Leverage Brain Inc.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Subjects of both sexes aged 20 years or older and younger than 65 years.

Exclusion criteria

Exclusion criteria: 1) Subjects with serious disorders on hepatic, kidney, cardiac, lung, digestive organs, blood, endocrine system, mental and metabolic system, or related severe past medical histories 2) Subjects who are under alternative treatment (acupuncture, chiropractic and etc.) or with treatment histories of within 1 month 3) Subjects with suicide thoughts 4) Subjects who regularly take foods containing Lactic acid bacteria or Bifidobacterium such as supplements 5) Subjects who regularly intake medical drugs or supplements that affect moods or fatigue 6) Subjects with medication allergy, food allergy, or serious history of these 7) Subjects who are pregnant, under lactation or expecting to be pregnant during this study 8) Subjects who participated in other study within 1 month prior to obtaining informed consent 9) Any candidates considered to be inappropriate for this study by the principal investigator based on their background, physical examination, etc.

Design outcomes

Primary

MeasureTime frame
Cerebral blood flow, Saliva Stress Index, Questionnaire

Countries

Japan

Contacts

Public ContactShigeru Imai

Leverage Brain Inc. Clinical Trial Department

imai@levbrain.com080-7290-0404

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026