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The Impact of MS-20 on Gut Microbiota Composition in Adult Individuals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04674839
Recruitment Status : Completed
First Posted : December 19, 2020
Last Update Posted : December 23, 2020
Sponsor:
Information provided by (Responsible Party):
Microbio Co Ltd

Tracking Information
First Submitted Date  ICMJE December 14, 2020
First Posted Date  ICMJE December 19, 2020
Last Update Posted Date December 23, 2020
Actual Study Start Date  ICMJE October 18, 2019
Actual Primary Completion Date September 4, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2020)
Change in Gut microbiota from baseline to 8th week [ Time Frame: baseline to 8th week ]
The composition, abundance and diversity of gut microbiota change from baseline in subjects treated with MS-20 or Placebo
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Impact of MS-20 on Gut Microbiota Composition in Adult Individuals
Official Title  ICMJE The Impact of MS-20 on Gut Microbiota Composition, Sera Endotoxin, Trimethylamine N-oxide, Metabolism and Immune Cell Profiling in Adult Individuals
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 appetite caused by cancer chemotherapy. Animal study revealed orally administration of MS-20 daily for 4 weeks altered the gut microbiota composition in mice. In addition, MS-20 could activate dendritic cell and improve immunotherapy response rate. Thus, it was hypothesis that MS-20 improves host immune activity thus ameliorate fatigue and increase weight is through alteration the gut microbiota composition.

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

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 subjects who meet the criteria of this study are planned to be enrolled. Eligible subjects will be randomized to receive placebo or MS-20 in a 1:1 ratio with 50 subjects in each arm.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Microbiota
Intervention  ICMJE
  • Drug: MS-20
    fermented soymilk product
  • Other: Placebo
    No active ingredient
Study Arms  ICMJE
  • Experimental: MS-20
    8 ml/day for 8 weeks
    Intervention: Drug: MS-20
  • Placebo
    8 ml/day for 8 weeks
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 14, 2020)
100
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 20, 2020
Actual Primary Completion Date September 4, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female subjects aged between 20 and 65 years old.
  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:

  1. The subject has soybean allergy.
  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04674839
Other Study ID Numbers  ICMJE MS20CLIIS01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Microbio Co Ltd
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Microbio Co Ltd
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Microbio Co Ltd
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP