Study of the effect on the gut microbiota by ingestion of probiotics

UMIN ID: UMIN000056730

Registered date:16/01/2025

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy adults
• Date of first enrollment: 2025/01/24
• Target sample size: 99
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Consumption of the probiotic-containing test food (1 bottle per day) for 4 weeks
Consumption of the 10x probiotic-containing test food (1 bottle per day) for 4 weeks
Consumption of the placebo food (1 bottle per day) for 4 weeks

Outcome(s)

• Primary Outcome: Composition and diversity of the intestinal microbiota after 0, 2 and 4 weeks of intake
• Secondary Outcome: Stool shape Status of fatigue Sleep habits Frequency of defecation Skin condition

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 64years-old
• Gender: Male and Female
• Exclude criteria: 1. Subjects with a history of laparoscopic surgery of the upper digestive tract (esophagus, stomach, duodenum) or laparoscopic surgery of the lower digestive tract (small intestine, large intestine, rectum). (excluding hemorrhoids, polypectomy and endoscopic treatment). 2. Subjects who have undergone gastric X-ray barium examination, small bowel endoscopy, colonoscopy, or bowel cleansing, or taken 2 L laxatives at a clinic or at home in the month prior to the date of consent or are scheduled to do so before the date stool collection after completion of intake. 3. Subjects who plan to take prescribed oral or injectable medications (not including eye drops or ointments) the date of stool collection after completion of intake. 4. Subjects with habits of consuming milk, yogurt, lactobacillus beverages, lactobacillus or bifidobacteria supplements, or probiotics at least once a week during the month prior to the date of consent (excluding subjects who can discontinue their intake from the date of consent until stool collection after completion of intake). 5. Subjects planning to travel abroad, for more than one week, or on a business trip between the date of consent and the date of stool collection after completion of intake. 6. Subjects with allergic to milk 7. Pregnant, lactating, or possibly pregnant. 8. Subjects deemed unsuitable participation in the trial by the principal investigator.

Related Information

• Primary Sponsor: Meiji Holdings Co., Ltd.
• Source(s) of Monetary Support: Meiji Holdings Co., Ltd.