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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016463

Enrollment

Registered

2015-02-06

Start date

2015-02-09

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: 4 weeks Test material: &quot

Powder of the Fermented Extract from Plants EX&quot

capsules Dose: One packet (1.2g)/day Usage: ingestion of test material along with the water just after dinner Duration: 4 weeks Test material: Placebo Dose: One packet (1.2g)/day Usage: ingestion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: a) Japanese healthy adults who are between 20 and 59 years old. b) Persons whose stool frequencies are between 2 and 5 times per 7 days

Exclusion criteria

Exclusion criteria: a) Persons who have previous medical history of malignant tumor or heart failure or myocardial infarction b) Patients being treated for at least one of following diseases atrial fibrillation, cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension and other chronic disease c) Persons who take medicines, herbal medicines, or supplement. d) Persons who are allergic to medicines, or products related to the test material of this trial e) Persons who habitually take foods that seem to be influential on intestinal environment, e.g., FOSHU, yogurt, and lactic fermenting beverage f) Persons who smoke g) Pregnant women, lactating women, or women who want to get pregnant during the trial period h) Persons who have been enrolled in the other clinical trials within last 3 months before the agreement for the participation to this trial i) Persons who are judged unsuitable to participate in this trial by physician

Design outcomes

Primary

Measure	Time frame
Intestinal bacterial flora Bifidobacterium Lactobacillales Bacteroides Prevotella Clostridium cluster IV Clostridium subcluster XIVa Clostridium cluster XI Clostridium cluster XVIII Others	—

Secondary

Measure	Time frame
Subjective symptom CAS-MT The faecal form scale	—

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