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Validation study for intestinal functions and anti-inflammatory effect in heathy Japanese adults: a double-blind randomized controlled trial

Validation study for intestinal functions and anti-inflammatory effect in heathy Japanese adults: a double-blind randomized controlled trial - Validation study for intestinal functions and anti-inflammatry effect in heathy Japanese adults

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000017794
Enrollment
30
Registered
2015-06-03
Start date
2015-06-04
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

Duration: 1 week Test food: Enterococcus faecalis KH2 strain supplement Dose: once a day (1 pack/day) Usage: ingestion of test food along with the water or hot water after dinner Duration: 1 week

Sponsors

ORTHOMEDICO, Inc.
Lead Sponsor
Seishin-kai Medical Association Inc, Takara Medical Clinic.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Healthy Japanese adults 2. Defecation (2~5 times/week) 3. Persons who are between 30 and 59 years old

Exclusion criteria

Exclusion criteria: 1. At least one previous medical history of malignant tumor, heart failure or myocardial infarction 2. Currently under treatment for either atrial fibrillation, cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, disease of digestive system (including ulcerative colitis, gastric ulcer, Diverticular Disease of the Colon, etc) or other chronic disease 3. Currently taking medicines, herbal medicines 4. Usually taking yogurt, oligosaccharide or lactic acid bacteria. 5. Allergic to medicines or foods related to the test food of this trial 6. Usually taking supplements and nutrient function foods 7. Pregnant, lactating, or planning to get pregnant during the trial period 8. Enrolled into other clinical trials within the last 3 months before agreeing to participate in this trial 9. Judged unsuitable for participating in this trial by physician

Design outcomes

Primary

MeasureTime frame
Intestinal bacterial flora

Secondary

MeasureTime frame
CAS-MT Bristol stool scale High sensitivity CRP

Countries

Japan

Contacts

Public ContactNaoko SUZUKI

ORTHOMEDICO, Inc. R&D Department

nao@orthomedico.jp03-3818-0610

Outcome results

None listed

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