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A randomized double-blind placebo-controlled trial for improving the intestinal environment in humans

A randomized double-blind placebo-controlled trial for improving the intestinal environment in humans - A trial for improving the intestinal environment in humans

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000024673
Enrollment
40
Registered
2016-11-01
Start date
2016-11-02
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: 2 weeks Test material: White Lactic acid bacterium Onakani Yell Dose: A bottle (65 mL) of per day Administration: Drink it after breakfast, lunch or dinner. Duration: 2 weeks Test mat

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. Persons who defecate two to five times per week

Exclusion criteria

Exclusion criteria: 1. Subjects who have at least one previous medical history of malignant tumor, heart failure or myocardial infarction 2. Subjects who being treated or have medical history for at least one of following diseases: cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases 3. Subjects who currently take Food for Specified Health Uses, Foods with Functional Claims, yogurt, and/or lactic fermenting beverage and/or food 4. Subjects who currently take medicines (include herbal medicines) and/or supplements 5. Subjects who are allergic to medicines or relate to the test food of this trial 6. Subjects who are pregnant, lactating, or planning to get pregnant during the trial period 7. Subjects who have enrolled into other clinical trials within the last 3 months before the date signed written informed consent in this trial 8. Subjects are judged as unsuitable for participating in this trial by physician for other reasons

Design outcomes

Primary

MeasureTime frame
1. Enterobacterial flora (Bifidobacterium, Lactobacillales, Bacteroides, Prevotella, Clostridium cluster IV, Clostridium cluster IX, Clostridium cluster XI, Clostridium cluster XVIII, and Clostridium subcluster XIVa) *1 Perform the test at 0 week and at 1 and 2 weeks after ingestion

Secondary

MeasureTime frame
1. The Japanese version of Constipation Assessment Scale MT version (CAS-MT) *1 Perform the test at 0 week and at 1 and 2 weeks after the ingestion 2. Stool form scale *2 Perform the test at 0 week and at 1 and 2 weeks after the ingestion 3. Bowel movement diary *3 Record it when having bowel movements

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