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
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|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|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|
8 ml/day for 8 weeks
fermented soymilk product
8 ml/day for 8 weeks
No active ingredient
- 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
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