Tokyo, May 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000054286) titled 'Efficacy Confirmation Test for Regular Intake -Preliminary validation of efficacy (improvement of bowel movements, anti-obesity, immunomodulation) of lactobacilli intake in healthy subjects' on May 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Tokai Gakuen University
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Exploratory validation of the efficacy of a normal amount of the test food consumed over a period of time
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Take one tablet of the test food per day for 4 weeks
Interventions/Control_2 - One tablet of control food per day for 4 weeks
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Female
Key inclusion criteria - (1) Healthy Japanese women who are between 18 and 60 years of age at the time of consent.
(2) Patients who are not receiving any treatment, whether seasonal, chronic, or sudden, by means of drugs, therapy, or treatment.
(3) Participants who fully understand the content of the clinical research and agree in writing of their own free will to participate in this clinical research.
(4) Patients whose body temperature is between 35.5 and 37.0.
(5) Patients who are able to prohibit binge eating and drinking based on three meals a day during the period of this clinical research.
(6) Patients who are able to use appropriate contraception during the period of this clinical research.
(7) Patients who are able to understand and comply with the administrative rules during this clinical research period.
Key exclusion criteria - (1) Persons with diseases of the gastrointestinal tract, liver, kidney, heart, and circulatory system that affect absorption, distribution, metabolism, and excretion of the test food.
(2) Patients with a history of major surgery on the gastrointestinal tract site such as gastrectomy, gastrointestinal suture, or intestinal resection (excluding polypectomy and appendectomy)
(3) Those with a history of cerebrovascular disease
(4) Those with hypersensitivity or specific constitution such as food allergy related to the test food
(5) Patients suspected of alcohol or drug dependence
(6) Patients who have participated in other clinical trials or clinical research within the past 84 days from the date of consent
(7) Donated 400mL blood within the past 84 days, 200mL blood within the past 28 days, or donated blood components (plasma and platelet components) within the past 14 days from the date of consent.
(8) Those who are lactating or pregnant.
(9) Those who are engaged in night shift.
Target Size - 40
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2024 Year 03 Month 12 Day
Date of IRB - 2024 Year 03 Month 12 Day
Anticipated trial start date - 2024 Year 05 Month 01 Day
Last follow-up date - 2024 Year 08 Month 05 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061998
Disclaimer: Curated by HT Syndication.
