Status:
COMPLETED
The Impact of MS-20 on Gut Microbiota Composition in Adult Individuals
Lead Sponsor:
Microbio Co Ltd
Conditions:
Microbiota
Eligibility:
All Genders
20-65 years
Phase:
NA
Brief Summary
MicrSoy-20 (MS-20), a fermented soymilk product, has been approved as an Over the counter (OTC) drug in 2011. The therapeutic effect of MS-20 is to ameliorate symptoms such as fatigue and loss of appe...
Detailed Description
This is a double-blind, placebo-controlled, investigator-initiated randomized trial to evaluate the impact of MS-20 on gut microbiota composition and abundance in healthy people. Approximately 100 sub...
Eligibility Criteria
Inclusion
- Male or female subjects aged between 20 and 65 years old.
- The subject is able to provide written informed consent by himself/herself and agrees to comply with all protocol requirements.
- The subject agrees to comply with the following two requirements:
- comply with all follow-up visit requirements according to the trial protocol.
- comply with all requirement regarding fecal samples collection, storage and delivery according to the trial protocol.
Exclusion
- The subject has soybean allergy.
- The subject is pregnant or lactating.
- The subject has received or is receiving chemotherapy.
- The subject has received any antibiotic, antifungals or antivirals (excluding topical agents and antiviral prophylaxis for hepatitis B virus) within 30 days prior to visit 1 .
- The subject has a clinically significant, currently active or underlying diarrhea (soft or loose stools more than three times in 24 hours) of infectious etiologies.
- The subject has received any steroids, immunosuppressant or anti-inflammation drugs within 30 days prior to visit 1.
- The subject has received probiotics or prebiotics 30 days prior to visit 1
- The subject who has been diagnosed a chronic kidney disease, chronic gut inflammatory disease, cancer, or autoimmune disease within 1 year before participating this study.
- Alcohol abuse, and smoking abuse.
- The subject has active inflammatory bowel disease or gastric ulcer.
- The subject currently is participating in studies involving other investigational drugs, medical devices, functional foods, or cosmetic.
- The subject is considered by the investigator as not suitable for the trial.
- The subject is judged by the investigator as not suitable for the trial due to concerns about possible non-compliance or severe concomitant illnesses.
Key Trial Info
Start Date :
October 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04674839
Start Date
October 18 2019
End Date
November 20 2020
Last Update
December 23 2020
Active Locations (1)
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1
Microbio Group
Taipei, Taiwan