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Study on the arrival of live bifidobacteria in the gastrointestinal tract. -Single group before-after test-

A study on the viability of bifidobacteria ingested as an acid-resistant processed preparation in the digestive tract. -Single group before-after test- - A study on the viability of bifidobacteria ingested as an acid-resistant processed preparation in the digestive tract.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000043672
Enrollment
10
Registered
2021-09-01
Start date
2021-03-21
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 volunteer

Interventions

Bifidobacterium-containing acid-resistant preparation Intervention period:14days

Sponsors

KSO Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Healthy men and women 20 to 64 years old 2.Subjects who have defecation every day and can collect stool at the designated date and time 3.Subjects who have received sufficient explanation about the purpose and content of the exam, have the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the exam in writing.

Exclusion criteria

Exclusion criteria: 1. Subjects who tend to have loose stools or constipation 2. Subjects who cannot stop the intake of foods containing certain Bifidobacterium from the screening test to the end of the 2-week test. 3. Subjects who are taking drugs that affect digestion and absorption, such as antibiotics 4. Subjects who cannot stop the intake of medicines, quasi-drugs, and health foods that affect the test during the test period. 5. Subjects with food allergies 6. Subjects who consume a large amount of alcohol on a daily basis 7. Subjects who have urgent medical treatment or have serious complications 8. Subjects with digestive disorders or surgical history that affect digestion and absorption and defecation 9. Subjects with a history of irritable bowel syndrome or a current medical history 10. Subjects background Persons who are judged to be inappropriate as subjects based on the answers to the questionnaire 11. Pregnant, willing to become pregnant during the exam, breastfeeding 12. Subjects with a history of drug dependence, alcohol dependence, or current medical history 13. Subjects who have participated in or are willing to participate in tests that take other foods or use drugs, and tests that apply cosmetics and drugs 14. Subjects judged as unsuitable for the study by the investigator for other reasons

Design outcomes

Primary

MeasureTime frame
Detection of certain live Bifidobacterium in feces. Time: Before and after the intervention (0day, 14days)

Secondary

MeasureTime frame
Viable cell count of certain Bifidobacterium in feces

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