Verification test of the effect of lactic acid bacterium containing foods intake on functions of the intestines.

UMIN ID: UMIN000032411

Registered date:01/06/2018

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Healthy adult
• Date of first enrollment: 2018/06/01
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

2-week intake of the test food Wash out 2-week intake of the placebo
2-week intake of the placebo Wash out 2-week intake of the test food

Outcome(s)

• Primary Outcome: Intestinal flora , Defecation frequency, Fecal amount , Bristol Stool Form Scale
• Secondary Outcome: Vital signs

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: 1)People who regularly drink or drink yogurt containing lactobacilli*Yogurt consumption will not be excluded if habit exists during the study. 2)Patients who cannot limit the use of drugs that may affect bowel movements (e.g., laxatives, intestinal regulators), health foods, specified health foods, functional labeling foods, health . 3)Subjects who were attending the hospital for bowel movements illness at study entry and were taking medications or taking over-the-counter laxatives. 4)Persons who are currently receiving treatment at a medical institution for gastrointestinal diseases that have an effect on the regulation of intestinal function, or those who have undergone. 5)Persons with or with a history of diseases that may significantly affect bowel movements, such as irritable bowel disease and ulcerative colitis. 6)Persons with or with a history of diseases such as diabetes, liver disease, kidney disease, or heart disease. 7)Persons currently undergoing exercise and diet therapy under the supervision of a physician. 8)Persons with diseases requiring constant medication. 9)Persons with a history of serious disease requiring medical treatment. 10)Persons with a history of drug or food allergy. 11)Subjects who are judged inappropriate as subjects based on the responses to the background questionnaire. 12)Subjects with significant deviations from reference ranges in pre-test physical, physical, and laboratory measurements. 13)Pregnant, lactating women, or women who wish to become pregnant during the study. 14)Persons with a current or past history of psychiatric disorders (e.g., depression). 15)Persons who work shift, such as night shift workers. 16)Patients who are receiving or have a history of drug dependence or drug abuse. 17)Individuals who have participated in other human clinical studies or are currently participating in other human clinical studies within the past 3 months. 18)Other subjects who are considered inappropriate as subjects by the investigator.

Related Information

• Primary Sponsor: HUMA R&D CORP
• Source(s) of Monetary Support: Pickles corporation