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Effects of fermented milk containing Bifidobacterium in healthy adults; Randomized, double-blind, placebo-controlled, parallel-group study

Effects of fermented milk containing Bifidobacterium in healthy adults; Randomized, double-blind, placebo-controlled, parallel-group study - Effects of fermented milk containing Bifidobacterium in healthy adults

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000027287
Enrollment
80
Registered
2017-05-21
Start date
2017-05-21
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

Intake fermented milk containing Bifidobacterium for 8 weeks Intake placebo for 8 weeks

Sponsors

KSO Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Healthy men and women aged from 20 to 65 years old. 2)Subjects whose stool frequency is about 3 to 5 times a week. 3)Subjects who have low relative abundance of bifidobacterium in feces 4)Subjects who have low diversity of microbiota in feces. 5)Subjects who understand details of the study and provides informed consent by documents.

Exclusion criteria

Exclusion criteria: 1)Subjects who regularly use intestinal drugs or laxatives. 2)Subjects who take drugs which affect gut microbiota such as antibiotics. 3)Subjects who have severe complication or serious diseases requiring an urgent treatment. 4)Subjects who have a chronic disease and use medicines constantly. 5)Subjects who have medical history of diseases or surgeries which affect digestion, absorption and defecation. 6)Subjects who repeat constipation and diarrhea such as irritable colitis. 7)Subjects who can't stop ingesting food containing lactic acid bacteria, bifidobacteria, oligosaccharide and viable bacteria. 8)Subjects who are under treatment for or have a history of drug addiction and/or alcoholism. 9)Subjects who are planning to become pregnant during the study or are pregnant or lactating. 10)Subjects who are planning to participate or already participating in other clinical studies. 11)Subjects who are judged as unsuitable for the study by the investigator for other reasons.

Design outcomes

Primary

MeasureTime frame
Gut microbiota

Secondary

MeasureTime frame
1) Fecal properties (water content, pH) 2) Fecal organic acids 3) Uremic toxins

Countries

Japan

Contacts

Public ContactEiji Yoshikawa

KSO Corporation Sales department

yoshikawa@kso.co.jp03-3452-7733

Outcome results

None listed

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