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-UMIN000018958

Enrollment

Registered

2015-09-09

Start date

2015-09-10

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

Period: 4 weeks Test food: Baker&#39

s yeast extract (0.5 g) Dose: three times a day (0.5 g for once) Usage: ingestion of the test food along with the water or hot water after each meals Period: 4 weeks Test food: Baker&#39

s yeast extract {Baker&#39

s yeast extract (0.08 g)+ dextrin (0.42 g)} Dose: three times a day (0.5 g for once) Usage: ingestion of the test food along with the water or hot water after each meals Period: 4 weeks Test food:

0.5 g) Dose: three times a day (0.5 g for once) Usage: ingestion of the test food along with the water or hot water after each meals

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Japanese healthy adults 2. The person who has a tendency for the loose stools

Exclusion criteria

Exclusion criteria: 1. At least one previous medical history of malignant tumor, heart failure or myocardial infarction 2. Currently under the treatment for either atrial fibrillation, cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, digestive disease (include colonic diverticulosis, ulcerative colitis, Diverticular Disease of the Colon) or other chronic diseases 3. Currently taking medicines, herbal medicines 4. Usually taking Food for Specified Health Uses (FOSHU), Functional Labeling System on health foods, yogurt or lactic acid bacteria beverage, which are related with intestinal regulation. 5. Allergic to medicines or foods related to the test food of this trial 6. Usually taking supplements or nutrient function foods in daily 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

Measure	Time frame
Intestinal bacterial flora (T-RFLP)	—

Secondary

Measure	Time frame
1. Intestinal bacterial flora (real-time PCR) 2. T-regulatory cell (T-reg) 3. The Japanese Version of the Constipation Assessment Scale MT version (CAS-MT)	—

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