Tokyo, Feb. 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060701) titled 'Investigation of the effects of the lactic acid bacteria on the regulation of intestinal function' on Feb. 23.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Kagoshima Immaculate Heart University
Condition:
Condition - Healthy adult
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigation the effect of test foods on the regulation of intestinal function in healthy Japanese subjects
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Intake of test foods (1 capsule per day) for 4 weeks
Interventions/Control_2 - Intake of placebo food (1 capsule per day) for 4 weeks
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - (1) Healthy adult males and females between 18 to 65 years
(2) BMI: less than 30 kg/m2
(3) Subjects who have a tendency toward constipation
(4) Subjects who have received sufficient explanation about the purpose and content of the examination, have the ability to consent, have a good understanding, volunteered to participate and agreed to participate in the examination in writing
Key exclusion criteria - 1. Subjects who were diagnosed with liver, kidney, gastrointestinal, heart, diabetes, or other diseases that may affect the results of this study, or who have a history of surgery
2. Subjects with a disease currently under treatment
3. Subjects who detect abnormal values by blood test
4. Subjects who determine ineligible by principal investigator
5. Subjects with drug or food allergies
6. Subjects who play high intensity sports and/or are on a diet
7. Subjects who can't stop using supplement, functional foods (including Food for Specified Health Uses or Foods with Function Claims), and/or Specified quasi-drugs during the current study periods
8. Subjects who are unable to stop taking "products that clearly state that lactic acid bacteria are an ingredient," excluding the test food of this study, from the time of obtaining consent, or who plan to take such products during the study period (this refers to products that clearly state that lactic acid bacteria are an ingredient, excluding those that are included in foods as a result of the manufacturing process.)
9. Subjects who are under treatment with medications
10. Those who have taken medicines that may affect the study within one month prior to the pre-test, or those who plan to take such medicines during the study period
11. Subjects who drink excessive alcohol, or who can't stop drinking from one day before each measurement
12. Subjects with smoking habit
13. Subjects with irregular life patterns and lifestyle of reversal of day and night
14. Subjects who have a habit of excessive eating and drinking
15. Subject who has been pregnant or subject who have a plan to become pregnant or breast feed during the study period
16. Subjects who is participating in the other study or planning to participate during the study period
17. Subjects who has taken the blood sampling more than 200 mL within 1 month, or plan the blood sampling during the study period
Target Size - 30
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 10 Month 12 Day
Date of IRB - 2025 Year 10 Month 14 Day
Anticipated trial start date - 2026 Year 02 Month 23 Day
Last follow-up date - 2026 Year 06 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069433
Disclaimer: Curated by HT Syndication.
