Tokyo, Sept. 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062801) titled 'Comparative study between site-visiting and remote trials' on Sept. 4.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Healthcare Systems Co., Ltd.
Condition:
Condition - Healthy Adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To exploratorily evaluate the changes in the intestinal environment and compliance with instructions during the trial period between site-visiting and remote trials when bifidobacteria supplements are ingested daily for 4 weeks by adults aged 18 to under 65 years.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - (site-visiting)Intake 2 capsules (once a day) of the test food daily for 4 weeks.
Interventions/Control_2 - (remote trials)Intake 2 capsules (once a day) of the test food daily for 4 weeks.
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - 1. Persons who received a sufficient explanation of the purpose and contents of the study, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate.
2. Japanese persons who are 18 years old or more and under 65 years old at the time of obtaining consent.
Key exclusion criteria - 1. Persons who have chronic illness, receiving medication, or have a serious disease history.
2. Persons who are allergic to the test food.
3. Persons who usually take a large amount of test food.
4. Persons who usually take medicine or functional foods for health uses (specified health foods, functional foods, and functional nutrition foods) that may affect the intestinal environment and antioxidant activity.
5. Persons who have participated in other studies within 1 month before the start of the study, or who intend to participate in another study after consenting to this study.
6. Persons who were judged as inappropriate for study participants by the principal investigator or trial supervising physician.
7. Persons who are pregnant, planning or hoping to be pregnant during the study period, or breastfeeding.
Target Size - 40
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 09 Month 02 Day
Date of IRB - 2026 Year 09 Month 02 Day
Anticipated trial start date - 2026 Year 09 Month 14 Day
Last follow-up date - 2027 Year 03 Month 01 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071891
Disclaimer: Curated by HT Syndication.
