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

• ClinicalTrials.gov Identifier: NCT04674839
• Recruitment Status: Completed
• First Posted: December 19, 2020
• Last Update Posted: December 23, 2020
• Sponsor: Microbio Co Ltd
• Information provided by (Responsible Party): Microbio Co Ltd

Tracking Information

• First Submitted Date: December 14, 2020
• First Posted Date: December 19, 2020
• Last Update Posted Date: December 23, 2020
• Actual Study Start Date: October 18, 2019
• Actual Primary Completion Date: September 4, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Impact of MS-20 on Gut Microbiota Composition in Adult Individuals
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Supportive Care
• Condition: Microbiota

Intervention

• Drug: MS-20
  fermented soymilk product
• Other: Placebo
  No active ingredient

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 14, 2020): 100
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: November 20, 2020
• Actual Primary Completion Date: September 4, 2020 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Taiwan

Administrative Information

• NCT Number: NCT04674839
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: Microbio Co Ltd
• Original Responsible Party: Same as current
• Current Study Sponsor: Microbio Co Ltd
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Microbio Co Ltd
• Verification Date: December 2020