Investigation of the effects of probiotics on the intestinal microbiota and drug-resistant bacteria of international travelers

UMIN ID: UMIN000054049

Registered date:04/04/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: N/A
• Date of first enrollment: 2024/06/01
• Target sample size: 100
• Countries of recruitment: Japan,Asia(except Japan)
• Study type: Interventional

Intervention(s)

One bottle of LCG lactobacilli per day (about 1 g) for 3 months
One bottle of dextrin per day (about 1 g) for 3 months

Outcome(s)

• Primary Outcome: Stool characteristics questionnaire: changes in intestinal environment based on Bristol Scale classification (volume, frequency of defecation, color, hardness, shape, and odor) with and without lactobacillus intake
• Secondary Outcome: Intestinal microbiota analysis(Changes in bacterial occupancy and diversity indices, Changes in bacterial counts by quantitative PCR method, Bacterial presence/absence and bacterial count changes by culture method)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 79years-old
• Gender: Male and Female
• Exclude criteria: 1. Who currently have a chronic disease of any kind and are receiving drug treatment 2. Those who have participated in other clinical trials or monitoring studies within one month prior to the start of the study,and those who wish to participate in other clinical trials during the period of this study 3. Persons who are taking or will take medicines, quasi-drugs, supplements, health foods, food for specified health uses (Tokuho), or functional foods such as lactic acid bacteria,bifidobacteria, or other intestinal regulators that may affect the results of this study, or are taking or will take them during the study 4. Those who are pregnant, plan to become pregnant during the examination period, or wish to become pregnant 5. Other subjects deemed unsuitable by the investigator

Related Information

• Primary Sponsor: Besuty & Health Research,Inc
• Source(s) of Monetary Support: Takanashi Milk Products Co.,Ltd.