Tokyo, June 12 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061070) titled 'A study to confirm the effect of food containing lactic acid bacteria intake on bowel movements' on June 12.

Study Type: Interventional

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

Primary Sponsor: Institute - MEGMILK SNOW BRAND Co., Ltd.

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

Objective: Narrative objectives1 - To evaluate the effects of continuous intake of food containing lactic acid bacteria for 4 weeks on defecation. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Intake of active food for 4 weeks Interventions/Control_2 - Intake of placebo food for 4 weeks

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - 1)Healthy males and females aged 20-64 years at the time of consent to participate in the study. 2)Individuals with 3 to 5 bowel movements per week during the run-in period. 3)Individuals who can visit the trial site on the scheduled visit dates, and who can collect and submit fecal samples within the specified period. 4)Individuals who understand the purpose and content of the study and provide online informed consent prior to participation. Key exclusion criteria - 1)Individuals who regulary take medicines/foods that affect the intestinal environment. 2)Individuals with a history of serious liver, kidney, cardiovascular, gastrointestinal, pulmonary, hematological, or metabolic disease. 3)Individuals with chronic diseases and who regularly use medicines. 4)Individuals with a current or history of drug or alcohol dependence. 5)Individuals with a history of gastrointestinal disease or surgery that affects digestion, absorption, or defecation. 6)Individuals with food allergies related to the test food. 7)Individuals with extremely irregular dailyand eating habits (including late-night workers). 8)Individuals who cannot restrict the use of drugs/foods that affect the study after providing informed consent. 9)Individuals with excessive exercise, drinking and smoking habits. 10)Pregnant or lactating women, or women who may become pregnant during the study period. 11)Individuals who have taken antibiotics within 1 month prior to providing informed consent or who will take antibiotics during the study period. 12)Individuals who have participated in, are currently participating in, or plan to participate in any other clinical research within 1 month prior to providing informed consent or during the study period. 13)Individuals who plan to change their lifestyle drastically after providing informed consent and before the end of the study. 14)Individuals who plan to travel abroad after providing informed consent and before the end of the study. 15)Individuals who are judged to be unsuitable based on their responses to the background questionnaire. 16)Other individuals who are judged by the investigator to be unsuitable for the study. Target Size - 90

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 02 Month 24 Day Date of IRB - 2026 Year 03 Month 02 Day Anticipated trial start date - 2026 Year 06 Month 12 Day Last follow-up date - 2026 Year 07 Month 25 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069881

Disclaimer: Curated by HT Syndication.