A Study on the Effect of Food Containing Microorganism on Immune Function -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study

Not Applicable

• Conditions: o

• Registration Number: JPRN-UMIN000046351
• Lead Sponsor: KSO Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-10
• Study Completion: 2022-04-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Subjects(who) 1)contract, are under treatment for or have a history of serious diseases (e.g., diabetes, liver disease, kidney disease, heart disease, thyroid gland disease, adrenal gland disease and/or metabolic disease) 2)have a chronic disease and regularly use medications 3)have a history and/or a surgical history of digestive disease affecting digestion and absorption 4)are judged as unsuitable for the current study by blood tests in screening test 5)have had no subjective symptoms of upper respiratory tract infection in the last two winters 6)contract pollinosis or allergic rhinitis and use drugs 7)can't stop using supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) affecting immune functions 8)take foods containing lactic acid bacteria or bifidobacteria at least twice a week 9)have excessive alcohol intake more than approximately 60 g/day of pure alcohol equivalent 10)are smokers 11)have a habit of strenuous exercise such as running or soccer 12)can't stop drinking from a day before each measurement 13)have declared allergic reaction to ingredients of test foods 14)are under treatment for or have a history of drug addiction and/or alcoholism 15)are shiftworker and/or midnight-shift worker 16)are planning to go abroad, such as on an overseas trip 17)are pregnant or breastfeed or planning to become pregnant 18)have used drugs (including antiallergic drugs and antibiotics) that are thought to affect immune function within two weeks prior to the screening test 19)have donated over 200 mL of blood and/or blood components within the last four weeks prior to the screening test or over 400 mL of blood and/or blood components within the last three months prior to the screening test 20)are planning to participate and/or had participated in other clinical studies within the last one month prior to the current study 21)are judged as unsuitable for the current study by the investigator for other reasons

Study & Design

• Study Type: Interventional
• Study Design: Not specified