Tokyo, Sept. 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059209) titled 'Additional validation of a study on short-chain fatty acid production by taking probiotics' on Sept. 26.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - KSO Corporation

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

Objective: Narrative objectives1 - To verify the amount of short-chain fatty acids produced by ingesting B. lactis GCL2505. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - 3-week intake of B. lactis GCL2505

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1) Healthy Japanese males and females from 20 to 65 years old. 2) Subjects who are able to collect and send the required amount of fecal samples within the designated period (with stable bowel movements) 3) Subjects who reside in the Tokyo metropolitan area or the Sapporo area during the study period 4) Subjects who have received sufficient explanation of the purpose and content of the study, have the capacity to consent, have voluntarily volunteered to participate based on a good understanding of the study, and have agreed to participate in the study in writing Key exclusion criteria - Subjects 1) who have a severe liver, kidney, heart, respiratory, endocrine, or metabolic disorders, or immunodeficiency. 2) who are taking medication for diabetes. 3) who suffer from a disease requiring urgent treatment or who have serious complications. 4) who have a history of or current drug or alcohol dependence. 5) who have recurrent gastrointestinal symptoms such as constipation or diarrhea. 6) who regularly consume alcohol (consuming more than 40 g/day of alcohol). 7) who are smokers. 8) who have extremely irregular eating habits. 9) who are unable to discontinue the intake of Foods for Specified Health Uses (FOSHU), foods with functional claims, nutritional supplements, or dietary supplements during the study period. 10) who have allergies to any food components contained in the study food. 11) who have taken antibiotics within one month before the start of intake. 12) who are pregnant, intend to become pregnant during the study period, or are breastfeeding. 13) who are currently participating in, or intend to participate in, other clinical studies involving foods, drugs, cosmetics, or pharmaceuticals. 14) deemed ineligible by the principal investigator. Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 08 Month 27 Day Date of IRB - 2025 Year 09 Month 03 Day Anticipated trial start date - 2025 Year 09 Month 27 Day Last follow-up date - 2026 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067720

Disclaimer: Curated by HT Syndication.