A randomized, double-blind, placebo-controlled, parallel-group comparative study of the effects of probiotics on the intestinal environment in healthy subjects.

A randomized, double-blind, placebo-controlled, parallel-group comparative study of the effects of probiotics on the intestinal environment in healthy subjects. - A study of the effects of probiotics on the intestinal environment in healthy subjects.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000056106

Enrollment

100

Registered

2024-11-08

Start date

2025-01-25

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

None

Interventions

Intake of probiotic yogurt for 14 days Intake of placebo yogurt for 14 days

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Healthy males and females who are aged 18-64 years at the time of obtaining consent. 2. Subjects who fully understand the purpose and content of this study and agree to participate in this study with a written informed consent.

Exclusion criteria

Exclusion criteria: 1. Subjects who regularly take medicines that affect the intestinal environment (antibiotics, bowel medicines, laxatives, etc.). 2. Subjects who regularly take foods or supplements that contain lactic acid bacteria, bifidobacteria or oligosaccharides, or that affect the intestinal environment. 3. Subjects who cannot stop taking health foods, supplements, foods for specified health uses, foods with functional claims, or foods with nutritional function claims. 4. Subjects receiving treatment for serious cancer, respiratory, hepatic, renal, cardiac, lung, gastrointestinal, blood, endocrine or metabolic diseases, or those with a serious history of these diseases. 5. Subjects with a history of digestive tract surgery (except adenoidectomy, appendicitis, etc.). 6. Subjects with serious drug or food allergies or a history of such allergies. 7. Subjects with a milk allergy or lactose intolerance 8. Subjects who are pregnant, lactating, or planning to become pregnant during the study period. 9. Subjects who have a drinking habit or cannot stop drinking during the specified period. 10. Subjects with a smoking habit. 11. Subjects currently taking or planning to take medicine for hay fever or perennial allergies during the study period. 12. Subjects who have participated in other clinical trials within 3 months of consent, or who plan to participate in other clinical trials during this study period. 13. Subjects who are judged ineligible to this study by principal investigator.

Design outcomes

Primary

Measure	Time frame
Gut metabolites	—

Secondary

Measure	Time frame
Gut microbiota	—

Countries

Japan

Contacts

Public ContactEiji Yoshikawa

KSO Corporation Clinical Trial Management department

eigyou27@kso.co.jp03-3452-7733

Outcome results

None listed

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