Investigation of the effects of lactic acid bacteria-containing food intake on the intestinal environment

UMIN ID: UMIN000053946

Registered date:22/03/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy male/female adults
• Date of first enrollment: 2024/04/04
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Consumption of test food 1 (2 capsules per day for 8 weeks)
Consumption of test food 2 (2 capsules per day for 8 weeks)
Consumption of Placebo food (2 capsules per day for 8 weeks)

Outcome(s)

• Primary Outcome: Defecation frequency
• Secondary Outcome: 1. Defecation status (frequency, quantity, property, color, feeling of incomplete evacuation, abdominal pain, odor) 2. Gut microbiota 3. Gut metabolomes 4. Abdominal symptoms (bloating, belching, gas) at times other than during defecation

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: 1. Subjects who have consumed products containing LAB (refers to those clearly indicated as ingredients, excluding those contained in the food as a result of the manufacturing process) for one month prior to the start of intervention, 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 (including supplements) that may affect the study (intestinal regulation, etc.) from the time consent is obtained. 3. Subjects who have taken drugs (antibiotics, antiflatulent, laxatives, etc.) that would affect the study one month prior to the pre-test, or during the study. 4. Subjects with a history of appendectomy. 5. 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. 6. 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. 7. Subjects with extremely irregular eating habits. 8. Subjects whose roommates plan to participate in the study. 9. Smokers. 10. Heavy alcohol drinkers. 11. Subjects with a history of serious diseases of the heart, liver, kidneys, digestive organs, etc. 12. Pregnant, lactating, or intending to become pregnant during the study. 13. Subjects allergic to medicines and foods. (Due to character limitation, the following will be listed in the "Others" section)

Related Information

• Primary Sponsor: Metagen, Inc.
• Source(s) of Monetary Support: ITO EN, LTD.