Tokyo, Aug. 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058797) titled 'Effects of lactic acid bacteria ingestion on subjective physical symptoms in healthy adult: A randomized, double-blind, placebo-controlled, parallel group comparison study.' on Aug. 13.
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 evaluate the effect of lactic acid bacteria ingestion on subjective physical symptoms for healthy adult.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Daily ingestion of powdered lactic acid bacteria for 12 weeks.
Interventions/Control_2 - Daily ingestion of placebo powder for 12 weeks.
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - 1. Healthy males and females who are aged 18-64 years at the time of obtaining consent.
2. Participants who fully understand the purpose and content of this study and agree to participate in this study with a written informed consent.
Key exclusion criteria - 1. Participants with serious diseases such as malignant tumors, respiratory, liver, renal, cardiac, pulmonary, gastrointestinal, hematologic, endocrine, and metabolic diseases, or history of these disease.
2. Participants with atopic dermatitis, bronchial asthma, or chronic bronchitis.
3. Participants with mental illness or autoimmune diseases.
4. Participants receiving or planning treatment or medication for hay fever or allergic rhinitis.
5. Participants with serious drug/food allergies or a history of such allergies.
6. Participants who have oral bleeding during the study.
7. Participants pregnant, planning pregnancy during the study period, or breastfeeding.
8. Participants with BMI =30 kg/m2.
9. Participants with a smoking habit.
10. Participants who regularly exceed the appropriate alcohol intake (20 g pure alcohol).
11. Participants who cannot abstain from alcohol for 2 days before evaluation.
12. Participants engaged in shift/night work, heavy labor, or go out less than 5 days/week.
13. Participants with an irregular lifestyle (e.g., frequently skips two meals/day).
14. Participants regular use (at least once/week) of drugs affecting immunity (e.g., antibiotics, steroids).
15. Participants regularly use immune-related supplements/functional foods, unable to stop during the study.
16. Participants unable to stop consuming foods with probiotics or oligosaccharides during the study.
17. Participants who have donated >200 mL blood in 1 month, or >400 mL in 3 months before consent.
18. Participants who have taken antibiotics within 4 weeks before screening.
19. Participants received a vaccination within 4 weeks prior to the screening, or plan to within 4 weeks before the 12-week exam.
20. Participants planning overseas travel during the study.
21. Participants who joined other clinical trials within 3 months before consent or planned during the study.
22. Participants judged ineligible to this study by principal investigator.
Target Size - 200
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 07 Month 31 Day
Date of IRB - 2025 Year 07 Month 31 Day
Anticipated trial start date - 2025 Year 10 Month 11 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067225
Disclaimer: Curated by HT Syndication.
