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

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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

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.


Condition or disease Intervention/treatment Phase
Microbiota Drug: MS-20 Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Impact of MS-20 on Gut Microbiota Composition, Sera Endotoxin, Trimethylamine N-oxide, Metabolism and Immune Cell Profiling in Adult Individuals
Actual Study Start Date : October 18, 2019
Actual Primary Completion Date : September 4, 2020
Actual Study Completion Date : November 20, 2020

Arm Intervention/treatment
Experimental: MS-20
8 ml/day for 8 weeks
Drug: MS-20
fermented soymilk product

Placebo
8 ml/day for 8 weeks
Other: Placebo
No active ingredient




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04674839


Locations
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Taiwan
Microbio Group
Taipei, Taiwan
Sponsors and Collaborators
Microbio Co Ltd
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Responsible Party: Microbio Co Ltd
ClinicalTrials.gov Identifier: NCT04674839    
Other Study ID Numbers: MS20CLIIS01
First Posted: December 19, 2020    Key Record Dates
Last Update Posted: December 23, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No