Tokyo, June 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061982) titled 'A study evaluating the effects of a gut microbiota-modulating component on the human fecal microbiota' on June 22.

Study Type: Others,meta-analysis etc

Primary Sponsor: Institute - Asahi Group Foods, Ltd.

Condition: Condition - Healthy volunteers Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The effects of food components on the gut microbiota are evaluated using in vitro culture of human fecal samples. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key 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. Key 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. Target Size - 15

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 06 Month 12 Day Date of IRB - 2026 Year 06 Month 18 Day Anticipated trial start date - 2026 Year 06 Month 22 Day Last follow-up date - 2028 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070905

Disclaimer: Curated by HT Syndication.