Tokyo, Nov. 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059722) titled 'Investigation of the effects of lactic acid bacteria-containing food intake on the intestinal environment' on Nov. 10.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Metagen, Inc.

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

Objective: Narrative objectives1 - Evaluate the effect of lactic acid bacteria (LAB) -containing food on the tendency to defecate and the intestinal environment for people prone to constipation. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Consumption of test food 1 (2 capsules per day for 8 weeks) Interventions/Control_2 - Consumption of test food 2 (2 capsules per day for 8 weeks)

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - (1) At informed consent, male/female subjects aged more than or equal to 20, and less than 65 years old. (2) Defecation frequency is between 3 and 5 times a week. (3) Subjects who can show their understanding of the study procedure and agreement with participating in the study by informed consent prior to the study. Key exclusion criteria - (1) Subjects who are unable to discontinue consumption of products containing LAB (refers to those clearly indicated as ingredients, excluding those contained in the food as a result of the manufacturing process) from the time consent is obtained, or those who plan to consume such products during the study. (2) Subjects who are unable to discontinue consumption of foods for specified health uses, foods with function claims, health foods that may affect the study (intestinal regulation, etc.) from the time consent is obtained. (3) Subjects who are unable to discontinue consumption of supplements (including tablets, capsules, and other forms distinct from ordinary foodstuffs, taken for nutritonal or functional puposes regardless of ingredients or functionality) from the time consent is obtained. (4) Subjects who have taken drugs (antibiotics, antiflatulent, laxatives, etc.) that would affect the study one month prior to the pre-test, or those sho plant to take during the study. (5) Subjects with a history of appendectomy. (6) Subjects who have undergone surgery that may affect the study (colonoscopy, removal of gallstones or gall bladder, gastric bypass surgery, bariatric surgery, etc.) within 6 months prior to obtaining consent. (7) Subjects who are expected to undergo a major change in their family, work, or other living environment (e.g., relocation, transfer, etc.) during the study. (8) Subjects with extremely irregular eating habits. (9) Subjects whose roommates plan to participate in the study. (10) Smokers. (11) Heavy alcohol drinkers. (12) Subjects with a history of serious diseases of the heart, liver, kidneys, digestive organs, etc. (13) Pregnant, lactating, or intending to become pregnant during the study. (14) Subjects allergic to medicines and foods.

(Due to character limitation, the following will be listed in the "Others" section) Target Size - 16

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 10 Month 27 Day Date of IRB - 2025 Year 10 Month 24 Day Anticipated trial start date - 2025 Year 11 Month 28 Day Last follow-up date - 2026 Year 03 Month 19 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068304

Disclaimer: Curated by HT Syndication.