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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000056730
Enrollment
99
Registered
2025-01-16
Start date
2025-01-24
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

Healthy adults

Interventions

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

Sponsors

Meiji Holdings Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Healthy men and women aged 20 to 64 years at the time of consent acquisition. The definition of a healthy subjects is as follows: -who have no history of gastrointestinal laparotomy. -who have not visited a medical institution within the past month. -who are not currently taking prescription oral or injectable medications (excluding eye drops or ointments). 2. Subjects who can give informed consent to partake in this study, after being provided with an explanation of the protocol detail.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
Composition and diversity of the intestinal microbiota after 0, 2 and 4 weeks of intake

Secondary

MeasureTime frame
Stool shape Status of fatigue Sleep habits Frequency of defecation Skin condition

Countries

Japan

Contacts

Public ContactSeiya Makino

Meiji Holdings Co., Ltd. Wellness Science Labs

seiya.makino@meiji.com042-632-5838

Outcome results

None listed

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