A study to confirm the effect of lactic acid bacteria intake on intestinal environment - study2: Randomized, placebo-controlled, parallel-group comparison study -

UMIN ID: UMIN000055714

Registered date:06/01/2025

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Healthy adults
• Date of first enrollment: 2025/01/13
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

8-week intake of low dose lactic acid bacteria
8-week intake of high dose lactic acid bacteria
8-week intake of placebo (not containing lactic acid bacteria)

Outcome(s)

• Primary Outcome: Fecal metabolites
• Secondary Outcome: Gut microbiome Fecal s-IgA Fecal amount, days of defecation, frequency of defecation, BSS, fecal color, fecal odor, feeling after defecation Questionnaire

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Subjects 1) who regularly use intestinal regulator or laxative drugs. 2) who have taken antibiotics within 3 weeks before collect the feces. 3) who suffer from a disease requiring urgent treatment. 4) with gastrointestinal diseases affecting digestion and absorption, or with a history of surgery. 5) who participate in a study involving the ingestion of other foods or the use of drugs. 6) who are pregnant, intend to become pregnant during the study period, or are breastfeeding.

Related Information

• Primary Sponsor: Ezaki Glico Co., Ltd.
• Secondary Sponsor: Hokkaido University
• Source(s) of Monetary Support: Ezaki Glico Co., Ltd.