Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy in probiotics on maintaining physical condition

UMIN ID: UMIN000045469

Registered date:14/09/2021

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: None
• Date of first enrollment: 2021/09/14
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Intake of powdered probiotic for 12 weeks
Intake of powdered placebo for 12 weeks

Outcome(s)

• Primary Outcome: Subjective symptoms of physical conditions

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1) Subjects who have disease or serious medical history in liver, kidney, heart, lung, gastrointestinal tract, blood, endocrine system, or metabolism, etc. 2) Subjects who regularly use oral or nasal medications 3) Subjects with severe perennial or seasonal allergic symptoms (those who develop symptoms during this study period and take steroids) 4) Subjects who are scheduled to be vaccinated against COVID-19 from two weeks before the start of this study to the end of this study 5) Subjects with serious medication allergy, food allergy, or history of these 6) Subjects who are pregnant, under lactation or expecting to be pregnant during this study 7) Subjects who participated in other study within 1 month prior to obtaining informed consent 8) Any candidates considered to be inappropriate for this study by the principal investigator based on their background, physical examination, etc.

Related Information

• Primary Sponsor: Matsumoto City Hospital
• Source(s) of Monetary Support: Morinaga Milk Industry Co., Ltd.