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

Effects of fermented milk containing Bifidobacterium on improvements of gastrointestinal symptoms 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-UMIN000024654
Enrollment
100
Registered
2016-10-31
Start date
2016-11-05
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

Fermented milk containing Bifidobacterium intake Fermented milk not containing Bifidobacterium intake

Sponsors

KSO Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Healthy men and women aged from 20 to 64 years old. 2) 8 and over for modified FSSG score. 3) Subjects who understand details of the study and provides informed consent by documents.

Exclusion criteria

Exclusion criteria: 1) Helicobacter pylori infection 2) Subjects who regularly use gastrointestinal drugs. 3) Functional Dyspepsia 4) Subjects who can't stop the ingestion of probiotics, prebiotics, foods containing lactic acid bacteria, bifidobacteria and other healthy foods which may affect gastrointestinal symptoms. 5) Subjects who have food allergy. 6) Subjects who have severe complication or serious diseases requiring an urgent treatment. 7) Subjects who have medical history of diseases or surgeries which affect digestion, absorption and defecation. 8) Subjects who are judged as unsuitable for the study by the blood test results of screening test. 9) Subjects who are planning to become pregnant during the study or are pregnant or lactating. 10) Subjects who are under treatment for or have a history of drug addiction and/or alcoholism. 11) Subjects who are planning to participate or already participating in other clinical studies. 12) Subjects who are judged as unsuitable for the study by the investigator for other reasons.

Design outcomes

Primary

MeasureTime frame
Gastrointestinal symptoms at 4 weeks after ingestion of test sample

Secondary

MeasureTime frame
Psychological symptoms, Breath test, Salivary stress marker, QOL at 4 weeks after ingestion of test sample

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