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Clinical evaluation of the intestinal regulating effects of probiotics intake

Clinical evaluation of the intestinal regulating effects of probiotics intake - Clinical evaluation of the intestinal regulating effects of probiotics intake

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000055322
Enrollment
80
Registered
2024-08-23
Start date
2024-08-26
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 subjects

Interventions

Sponsors

HUMA R&D CORP
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Healthy adult who aged 20 years or older and younger than 65 years 2.Subjects with feces frequency 2-5 times / week

Exclusion criteria

Exclusion criteria: 1.Subjects diagnosed with constipated by a physician. 2.Subjects with chronic conditions such as brain disease, malignancies, gastrointestinal, immunological, and respiratory diseases, diabetes mellitus, liver disease (hepatitis), and kidney, heart, thyroid, adrenal, and metabolic diseases, and subjects who currently have or previously had serious manifestations of these conditions. 3.Subjects who routinely use from using medicines or quasi-drugs that affect bowel control, such as bowel regulators, laxatives and laxatives. 4.Subjects who habitually consume yogurt, natural cheese, kefir, lactic acid bacteria beverages, supplements or syrups containing bifidobacteria, lactobacilli, oligosaccharides, etc., or Foods with Function Claims or Foods for Specified Health Uses containing oligosaccharides as a functional substance. 5.Subjects who are unable to stop using medicines, quasi-drugs, foods or supplements that affect bowel regulators during the study period. 6.Subjects receiving medication or outpatient treatment for a disease. 7.Subjects who are at risk of having allergic reactions to drugs or foods. 8.Subjects with current or previous history of drug dependence or alcohol dependence. 9.Heavy users of alcohol (the mean consumption of pure alcohol is 60 g/day or more). 10.Subjects receiving exercise or diet therapy under the supervision of a physician. 11.Subjects who have extremely irregular life rhythms due to night work, shift work, etc. 12.Subjects whose eating, sleeping, and other habits are extremely irregular. 13.Subjects who are having a very unbalanced diet. 14.Smoker 15.Subjects who are currently pregnant or lactating, may become pregnant during the study period. 16.Subjects who participated in another clinical study/research within 3 months before the date of informed consent or who plan to participate in another clinical study/research during the study period.

Design outcomes

Primary

MeasureTime frame
Fecal frequency

Secondary

MeasureTime frame
(Secondary outcomes) Fecal characteristics, Gastrointestinal symptoms

Countries

Japan

Contacts

Public ContactHiroyuki Miyazawa

HUMA R&D CORP Clinical Development Department

rd@huma-rd.co.jp03-3431-1260

Outcome results

None listed

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