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Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy of the bifidobacteria on sleep quality

Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy of the bifidobacteria on sleep quality - Clinical study to evaluate the efficacy of the bifidobacteria on sleep quality

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000058362
Enrollment
100
Registered
2025-07-07
Start date
2025-07-14
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

Sponsors

Yamaguchi Health Lab
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Participants aged more than 20 years, less than 65 years. 2) Participants with a total score of 6 or higher on the Pittsburgh Sleep Questionnaire

Exclusion criteria

Exclusion criteria: 1)Participants with a serious disease or a history of a serious disease 2)Participants with a history or current history of insomnia, psychiatric disorders, drug dependence, or alcohol dependence 3)Participants who have been diagnosed with sleep apnea syndrome or suspected sleep apnea syndrome (including those being treated with CPAP) 4)Participants who are currently undergoing treatment for sleep, stress, or fatigue, or using medications related to sleep, stress, or fatigue 5)Participants who cannot discontinue intake of food for specified health use, food with functional claims, food with nutrient function claims, supplements, etc. that may affect sleep during the study period 6)Participants who cannot discontinue intake of foods or supplements containing lactobacilli, bifidobacteria, oligosaccharides, etc. during the study period 7)Participants who cannot discontinue intake of caffeine-rich food and beverages, alcohol, or smoking during the period of EEG measurement from 4 hours before bedtime to sleep 8)Excessive alcohol drinkers 9)Excessive smorkers 10)Participants who have more than 3 interruptions of sleep due to urination 11)Participants who do not have fixed days off, who work day and night shifts, and who work shift work (excluding participants who have a fixed work schedule per week as housewives, part-time workers, etc.) 12)Participants who plan to travel abroad during the study period 13)Participants who are participating or intend to participate in other tests 14)Participants with a history of drug allergy or food allergy 15)Participants who may experience allergic symptoms during the study period, or who are using or intend to use drugs for allergic symptoms 16)Pregnant women, intending mothers, and lactating mothers 17)Participants with sensitive skin who may develop skin irritation from adhesive plasters or adhesive tapes 18)Participants who are judged to be inappropriate for this study by the principal investigator or the examination doctor

Design outcomes

Primary

MeasureTime frame
Sleep quality (EEG)

Countries

Japan

Contacts

Public ContactHisao Nakatani

Yamaguchi Health Lab General manager

info@yamaguchi-hl.com083-976-4095

Outcome results

None listed

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