Tokyo, Dec. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059010) titled 'A study to confirm the effect of food containing bifidobacterium on bowel movements' on Dec. 10.

Study Type: Interventional

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

Primary Sponsor: Institute - Transgenic, Inc.

Condition: Condition - constipation Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the effects of continuous intake of food containing bifidobacterium for 4 weeks on bowel movements. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Take 3 hard capsules containing Bifidobacterium once a day for 4 weeks. Interventions/Control_2 - Take 3 hard capsules without Bifidobacterium once a day for 4 weeks.

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - 1) Men and women aged 20 to 64 years at the time of consent to participate in the study. 2) Subjects with 3 to 5 bowel movements per week in background survey. 3) Subjects who can visit the testing institution on the scheduled visit date. 4) Subjects who fully understand the purpose and content of the study and agree in writing prior to the start of the study. Key exclusion criteria - 1) Subjects taking medicines/foods that affect the intestinal environment regularly. 2) Subjects with a history of serious liver, kidney, cardiovascular, gastrointestinal, pulmonary, blood, or metabolic disease. 3) Subjects with chronic diseases and regular users of medicines. 4) Subjects with a history or current history of drug or alcohol dependence 5) Subjects with a history of gastrointestinal disease or surgery that affects digestion, absorption, or defecation. 6) Subjects with food allergies related to the test food. 7) Subjects with extremely irregular daily habits and eating habits (including late-night workers). 8) Subjects who cannot restrict the use of drugs/foods that affect the study after obtaining consent. 9) Subjects with excessive habits of exercise, drinking and smoking. 10) Pregnant or lactating women or women who may become pregnant during the study period. 11) Subjects who have taken or will take antibiotics within 1 month prior to obtaining consent during the study period. 12) Participated, are currently participating, or will participate during the study period, in any other clinical research within 1 month prior to obtaining consent. 13) Subjects who plan to change their lifestyle drastically after obtaining consent and before the end of the study. 14) Subjects who plan to travel abroad after obtaining consent and before the end of the study. 15) Subjects judged to be unsuitable based on their answers to the background questionnaire. 16) Other subjects who are judged by the investigator to be unsuitable for the study. Target Size - 80

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2024 Year 11 Month 22 Day Date of IRB - 2024 Year 11 Month 29 Day Anticipated trial start date - 2025 Year 02 Month 10 Day Last follow-up date - 2025 Year 03 Month 29 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064741

Disclaimer: Curated by HT Syndication.