Tokyo, July 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058497) titled 'A crossover open-label study comparing the gut environment improving effects of two strains of Bifidobacterium' on July 17.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Open -no one is blinded Control - Dose comparison

Primary Sponsor: Institute - NISSIN YORK CO., LTD.

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

Objective: Narrative objectives1 - The purpose of this study is to exploratory evaluate the effects on the intestinal environment of taking a bifidobacteria-containing supplement (dead bacteria) and a milk drink (live bacteria) for four weeks. Two different strains of bifidobacteria will be administered to the same study subjects in a crossover manner, and differences in the strains and food form will be evaluated. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - Intake the test food (supplement A) for 4 weeks, then take another test food (supplement B) for 4 weeks after washout. Interventions/Control_2 - Intake of test food (dairy drink A) for 4 weeks, then take another test food (dairy drink B) for 4 weeks after washout.

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1. Subjects aged 20 to 65 at the time of obtaining consent 2. Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent Key exclusion criteria - 1.Subjects with serious cardio-vascular, hepatic, renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders 2.Subjects receiving treatment for a gastrointestinal disease currently or those who have had gastrointestinal surgery 3.Subjects who are suffering from or have a history of a disease that may affect defecation 4.Subjects who take regularly pharmaceuticals or quasi-drugs which having the efficacy for microbiome such as intestinal regulator 5.Subjects who have used antibiotics within the past month 6. Subjects who have continuously consumed foods containing bifidobacterium within the past 3 months 7.Subjects who plan to make significant changes to their lifestyle (e.g., diet, sleep, exercise) during the study period 8. Subjects with smoking habits 9. Subjects with irregular lifestyles due to night shifts 10. Subjects who have allergies to the test food 11.Female subjects who are pregnant or lactating, or intending to become pregnant during the study 12.Subjects who took part in another study within 3 months prior to the start of the present study or who is currently taking part in another study 13. Subjects deemed unsuitable by the investigator Target Size - 24

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 06 Month 24 Day Date of IRB - 2025 Year 07 Month 09 Day Anticipated trial start date - 2025 Year 07 Month 23 Day Last follow-up date - 2025 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066840

Disclaimer: Curated by HT Syndication.