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

UMIN ID: UMIN000056106

Registered date:08/11/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: None
• Date of first enrollment: 2025/01/25
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: Gut metabolites
• Secondary Outcome: Gut microbiota

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: KSO corporation
• Source(s) of Monetary Support: Morinaga Milk Industry CO., LTD.