Tokyo, Jan. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060269) titled 'Immune Function Evaluation Test for Levilactobacillus brevis subsp. coagulans FERM BP-4693 (Labre)' on Jan. 15.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Clinical Creative Co., Ltd.
Condition:
Condition - healthy person
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The primary endpoint will be the intergroup difference in the cumulative number of Good Health Days (GHD) during the intervention period in adults aged 20 to 79 years who consumed Lactobacillus brevis-containing food for 12 weeks. Secondary endpoints include symptom duration, blood cytokines, immune phenotypes assessed by CyTOF/multicolor flow cytometry, and quality of life (QOL).
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Lactobacillus reuteri: Capsules containing 100 billion CFU (colony-forming units) of Lactobacillus reuteri per day
Interventions/Control_2 - Placebo group: Capsules identical in appearance and taste but not containing Lactobacillus brevis
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - 1. Individuals who have obtained consent in writing or by electronic means
2. Japanese adult men and women aged 20 to 79 at the time consent was obtained
Key exclusion criteria - 1. Individuals with immunosuppression or chronic diseases
2. Individuals currently taking immunosuppressants, anti-inflammatory drugs, or antibacterial drugs
3. Individuals who habitually use excessive amounts of moisturizers or laxatives in daily life
4. Individuals who habitually consume specific lactic acid bacteria preparations or supplements in daily life
5. Individuals who are pregnant or breastfeeding, or who plan/intend to become pregnant during the study period
6. Individuals with allergies to standard foods/test foods
7. Individuals unable to refrain from receiving new vaccinations (seasonal influenza/COVID-19) during the study period after consent is obtained
8. Individuals unable to complete each questionnaire according to the schedule
9. Individuals with a history of overseas travel within 2 weeks prior to the consent date or planning overseas travel during the study period
10. Individuals without a smartphone
11. Individuals who participated in another study within one month prior to study initiation, or who plan to participate in another study after providing consent for this study
12. Individuals deemed ineligible by the physician.
Target Size - 60
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 04 Day
Date of IRB - 2025 Year 11 Month 26 Day
Anticipated trial start date - 2026 Year 01 Month 15 Day
Last follow-up date - 2026 Year 05 Month 02 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068932
Disclaimer: Curated by HT Syndication.
