The Impact of MS-20 on Gut Microbiota Composition in Adult Individuals
NCT ID: NCT04674839
Last Updated: 2020-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2019-10-18
2020-11-20
Brief Summary
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In this study, the ability of MS-20 in modulating gut microbiota and the subset of microbiome to be altered by MS-20 was investigated.
Detailed Description
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The study comprises of a 7 days screening period, a 8-week treatment period and a 8-week follow-up period. Eligible subjects will receive MS-20 or placebo every day during the treatment period. Participants should not use any probiotics and prebiotics during the trial. In addition, All medications (especially antibiotics) should be recorded and documented, however, fluoroquinolones and vancomycin will be banned during the trial.
The fecal gut microbiota, serum, and urea were collect at indicated time. The gut microbiota composition, gut microbiota metabolite, and serum biochemical items will be analysed.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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MS-20
8 ml/day for 8 weeks
MS-20
fermented soymilk product
Placebo
8 ml/day for 8 weeks
Placebo
No active ingredient
Interventions
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MS-20
fermented soymilk product
Placebo
No active ingredient
Eligibility Criteria
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Inclusion Criteria
2. The subject is able to provide written informed consent by himself/herself and agrees to comply with all protocol requirements.
3. The subject agrees to comply with the following two requirements:
1. comply with all follow-up visit requirements according to the trial protocol.
2. comply with all requirement regarding fecal samples collection, storage and delivery according to the trial protocol.
Exclusion Criteria
2. The subject is pregnant or lactating.
3. The subject has received or is receiving chemotherapy.
4. 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 .
5. 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.
6. The subject has received any steroids, immunosuppressant or anti-inflammation drugs within 30 days prior to visit 1.
7. The subject has received probiotics or prebiotics 30 days prior to visit 1
8. 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.
9. Alcohol abuse, and smoking abuse.
10. The subject has active inflammatory bowel disease or gastric ulcer.
11. The subject currently is participating in studies involving other investigational drugs, medical devices, functional foods, or cosmetic.
12. The subject is considered by the investigator as not suitable for the trial.
13. The subject is judged by the investigator as not suitable for the trial due to concerns about possible non-compliance or severe concomitant illnesses.
20 Years
65 Years
ALL
Yes
Sponsors
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Microbio Co Ltd
INDUSTRY
Responsible Party
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Locations
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Microbio Group
Taipei, , Taiwan
Countries
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Other Identifiers
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MS20CLIIS01
Identifier Type: -
Identifier Source: org_study_id