Tokyo, March 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060983) titled 'A study on changes in antiviral immune responses induced by lactic acid bacteria intake: A randomized, double-blind, placebo-controlled, parallel-group trial' on March 20.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - KSO Corporation
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To confirm the effect of study food intake on immune responses
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - 8-week daily intake of lactic acid bacteria
Interventions/Control_2 - 8-week daily intake of placebo (not containing lactic acid bacteria)
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1) Healthy Japanese males and females from 20 to 64 years old.
2) Individuals who self-identify as being susceptible to colds or influenza.
3) Individuals who received sufficient explanation of the purpose and details of the study, have the capacity to provide consent, fully understood the information, voluntarily agreed to participate, and provided written informed consent.
Key exclusion criteria - 1) Individuals with severe diseases such as diabetes, renal or hepatic disorders, cardiac diseases, thyroid disorders, adrenal disorders, psychiatric disorders, autoimmune diseases, or other metabolic diseases, or those currently undergoing treatment for these conditions (except for individuals deemed eligible by the principal investigator).
2) Individuals with chronic diseases who routinely take medication.
3) Individuals with atopic dermatitis, bronchial asthma, or chronic bronchitis.
4) Individuals who are unable to refrain from consuming foods containing lactic acid bacteria, bifidobacteria, oligosaccharides, or live microorganisms during the study period.
5) Individuals who plan to regularly visit a clinic or use prescription medications each year due to hay fever or allergic rhinitis.
6) Individuals with a history or current diagnosis of drug dependence or alcohol dependence.
7) Individuals with gastrointestinal diseases or a history of gastrointestinal surgery that may affect digestion or absorption (appendectomy excluded).
8) Individuals who are unable to discontinue supplements or health foods (including Foods for Specified Health Uses and Foods with Functional Claims) during the study period.
9) Individuals who are habitual smokers.
10) Individuals with extremely irregular dietary habits (e.g., one meal per day or insufficient nutritional intake).
11) Individuals with excessive alcohol consumption, defined as more than approximately 60 g of pure alcohol per day.
12) Individuals who are unable to abstain from alcohol for two days prior to the screening and each subsequent test visit.
13) Individuals who report having food allergies to any components of the study product.
14) Individuals engaged in shift work, night work, or physically demanding labor such as heavy lifting.
15) Individuals who go out less than twice a week.
Due to character limitations, part of the exclusion criteria is presented in the 'Other Related Information' section.
Target Size - 100
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 01 Month 22 Day
Date of IRB - 2026 Year 01 Month 22 Day
Anticipated trial start date - 2026 Year 03 Month 20 Day
Last follow-up date - 2026 Year 06 Month 21 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069740
Disclaimer: Curated by HT Syndication.
