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A study evaluating the effects of a gut microbiota-modulating component on the human fecal microbiota

A study evaluating the effects of a gut microbiota-modulating component on the human fecal microbiota - A study evaluating the effects of a gut microbiota-modulating component on the human fecal microbiota

Status
Active, not recruiting
Phases
Unknown
Study type
Unknown
Source
JPRN
Registry ID
JPRN-UMIN000061982
Enrollment
15
Registered
2026-06-22
Start date
2026-06-22
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteers

Interventions

None listed

Sponsors

Asahi Group Foods, Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Healthy Japanese men and women aged 20 to 59 at the time of obtaining informed consent to participate in the study. 2) Individuals who have 5 to 10 bowel movements per week. 3) Individuals who received a thorough explanation of the study's purpose and content and signed the informed consent form prior to the start of the study. 4) Individuals whom the principal investigator or other designated personnel determined to be suitable for participation in the study.

Exclusion criteria

Exclusion criteria: 1) Individuals currently undergoing treatment for a serious illness. 2) Individuals with chronic diarrhea or constipation. 3) Individuals who do not habitually eat three meals a day. 4) Individuals who habitually consume an average of 20 grams or more of pure alcohol per day. 5) Individuals who regularly take pharmaceuticals, quasi-drugs, or traditional Chinese medicines. 6) Individuals who regularly consume health foods. (including foods for specified health uses, foods with nutritional functions, foods with functional claims, supplements, and other so-called health foods) that may affect the evaluation criteria 7) Individuals who are unable to refrain from consuming health foods or medications that may affect the evaluation criteria for one month prior to stool collection. 8) Individuals currently receiving medical treatment for a gastrointestinal disorder, or those with a history of gastrointestinal surgery (excluding appendectomy) 9) Individuals currently participating in a clinical trial, or who have participated in another clinical trial within the past 3 months prior to the date of informed consent. 10) Individuals who cannot maintain their usual lifestyle habits from the preliminary examination through the main examination. 11) Individuals who are menstruating at the time of the main examination, or who may be menstruating. 12) Individuals who are pregnant, breastfeeding, or planning to become pregnant. 13) Any other individuals deemed unsuitable as participants in this trial by the principal investigator or other designated personnel.

Design outcomes

Primary

MeasureTime frame
Short-chain fatty acids

Secondary

MeasureTime frame
Intestinal microbiota Putrefactive substances Metabolites derived from intestinal bacteria

Countries

Japan

Contacts

Public ContactYota Kobayashi

Asahi Group Foods, Ltd. R&D Division, Technology Development Department I

yota.kobayashi@asahi-gf.co.jp070-3187-3950

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026