Tokyo, March 19 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060960) titled 'Study to confirm the effect of food containing bifidobacterium intake on improving the intestinal environment' on March 19.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - APO PLUS STATION CO., LTD.
Condition:
Condition - Not applicable
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Confirm the effect of improving the intestinal environment when a food containing bifidobacteria is consumed continuously for 4 weeks.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Daily intake of a food containing bifidobacterium for 4 weeks.
Interventions/Control_2 - Daily intake of placebo for 4 weeks.
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - 1)Healthy Japanese males and females aged 20 to 64 years,at the time of informed consent.
2)Participant with 3 to 5 bowel movements per week during the 2-week pre-observation period.
3)Participant who can visit the trial site on the scheduled visit date.
4)Participant who fully understand the purpose and content of this study and provided written consent prior to trial initiation.
Key exclusion criteria - 1)Participant taking medicines/foods that affect the intestinal environment three or more times per week.
2)Participant with a history of serious liver, kidney, cardiovascular, gastrointestinal, pulmonary, blood, or metabolic disease.
3)Participant with chronic diseases and regular users of medicines.
4)Participant with a history or current history of drug or alcohol dependence.
5)Participant with a history of gastrointestinal disease or surgery that affects digestion, absorption, or defecation.
6)Participant with food allergies related to the test food.
7)Participant with extremely irregular daily habits and eating habits (including late-night workers).
8)Participant who cannot restrict the use of drugs/foods that affect the study after obtaining consent.
9)Participant with excessive exercise, alcohol consumption, or smoking habits.
10)Pregnant or lactating women or women who may become pregnant during the study period.
11)Participant who have taken antibiotics within 1 month prior to obtaining consent, or plan to take them during the study period.
12)Participant who have participated in any other clinical research within 1 month prior to obtaining consent, are currently participating, or are scheduled to participate during the study period.
13)Participant who plan to change their lifestyle drastically after obtaining consent and before the end of the study.
14)Participant who plan to travel abroad after obtaining consent and before the end of the study.
15)Participant judged to be unsuitable based on their answers to the background questionnaire.
16)Other participant who are judged by the investigator to be unsuitable for the study.
Target Size - 110
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 02 Month 18 Day
Date of IRB - 2026 Year 02 Month 25 Day
Anticipated trial start date - 2026 Year 03 Month 23 Day
Last follow-up date - 2027 Year 01 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069756
Disclaimer: Curated by HT Syndication.
