Tokyo, July 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058633) titled 'Verification study of the effect of test food intake on gastrointestinal symptoms' on July 29.

Study Type: Interventional

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

Primary Sponsor: Institute - ASPAC KIGYO K.K

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

Objective: Narrative objectives1 - Examine whether foods containing lactic acid bacteria are actually effective for improving the intestinal environment in healthy adult men and women who are concerned about their stomach (gastrointestinal) condition. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Intake 2 tablets once a day with water or lukewarm water for 8 weeks.

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - 1. Persons who are male or female and aged 18 to 74 2. Persons who are not suffering from any illness related to the stomach or intestines (have not been diagnosed with any illness) and are concerned about their stomach (stomach or intestines) but have been determined not to require immediate treatment 3. Persons who fully understand the purpose and content of the study and voluntarily agree to participate in the study Key exclusion criteria - 1. Persons who may experience stomach pain when eating foods containing lactobacillus products such as lactobacillus (FM8 strain) 2. Persons who have been diagnosed with a digestive disease, previously undergone digestive surgery, and will require digestive surgery in the future 3. Persons who regularly use lactobacillus products such as lactobacillus (FM8 strain) (3 days or more per week) and those who have regularly used lactobacillus products within the 3 months prior to the pre-test. 4. Persons who have been diagnosed with malignant tumors, currently receiving treatment for cranial nerve, heart, kidney, diabetes, or thyroid dysfunction, and with a history of serious illnesses such as liver disease, excluding illnesses like hypertension, which principal investigator determined will not affect the evaluation of the research. 5. Persons who drink a large amount of alcohol (60 g or more of alcohol per day: approximately 1500 mL of beer, 540 mL of wine, 3 cups of sake, or 180 mL of double-sized whiskey) 6. Persons who are at risk of developing allergies related to the test foods 7. Persons who are deemed unsuitable as research subjects based on their responses to a background survey 8. Persons who have participated in other research during one month prior to the start of this research, or plan to participate in other research after consenting to this research. 9. Persons who are judged to be ineligible by the principal investigator Target Size - 20

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2024 Year 11 Month 02 Day Date of IRB - 2024 Year 11 Month 02 Day Anticipated trial start date - 2024 Year 12 Month 01 Day Last follow-up date - 2025 Year 04 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067048

Disclaimer: Curated by HT Syndication.