Tokyo, Oct. 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059488) titled 'Safety Assessment of a Functional Food in Healthy Volunteers' on Oct. 27.

Study Type: Interventional

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

Primary Sponsor: Institute - BEYOND KAMPO Inc.

Condition: Condition - Safety Assessment of a Functional Food in Healthy Volunteers Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This open-label exploratory study will be conducted in healthy men and women aged between 20 and 65 years who experience abdominal discomfort, such as bloating, associated with chronic constipation. The study aims to evaluate the safety and exploratory efficacy of daily intake of the test food (a lactic acid bacteria-containing product) over a 4-week period. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - Test product Duration of test food intake 4 weeks

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1) Men and women aged 20 to 65 years at the time of obtaining consent to participate in the study. 2) Individuals suffering from chronic constipation and abdominal pain, bloating, or discomfort. 3) Individuals without chronic physical illnesses, including skin diseases. 4) Individuals who have received a full explanation of the purpose and content of the study, are competent to consent, fully understand the content, and voluntarily volunteer to participate and provide written consent. 5) Individuals who are able to attend the study on the designated date and undergo the examination. Key exclusion criteria - 1) Those currently suffering from any illness and receiving drug treatment. 2) Those with a history or current illness of mental illness, sleep disorder, hypertension, diabetes, dyslipidemia, or other serious illnesses. 3) Those who have taken medication for the purpose of treating an illness within the past month (excluding those taking medication for headaches, menstrual pain, colds, etc.). 4) Those with a history or current serious illness involving the liver, kidneys, heart, lungs, blood, etc. 5) Those with a history or current serious coexisting illness involving the digestive system. 6) Subjects with drug or food allergies 7) Subjects currently or in the past month regularly consuming foods for specified health uses, foods with functional claims, or health foods 8) Subjects who regularly consume fermented foods rich in lactic acid bacteria (e.g., cheese, yogurt, kimchi, and soybeans) 9) Subjects whose daily alcohol intake exceeds 30g of pure alcohol per day 10) Subjects who may change their lifestyle during the study period (e.g., long-term travel) 11) Pregnant, nursing, or potentially pregnant during the study period. 12) Currently participating in another human clinical trial, or within the last three months since participating in another human clinical trial. 13) Other individuals who the investigator deems inappropriate for this study. Target Size - 10

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 10 Month 09 Day Date of IRB - 2025 Year 10 Month 21 Day Anticipated trial start date - 2025 Year 10 Month 24 Day Last follow-up date - 2025 Year 11 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068042

Disclaimer: Curated by HT Syndication.