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

NCT04674839 | Completed

• 1 other identifier: MS20CLIIS01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Microbiota

Outcome Measures

Primary Outcomes (1)

• Change in Gut microbiota from baseline to 8th week

  The composition, abundance and diversity of gut microbiota change from baseline in subjects treated with MS-20 or Placebo

  baseline to 8th week

Study Arms (2)

MS-20

EXPERIMENTAL

8 ml/day for 8 weeks

Drug: MS-20

Placebo

OTHER

8 ml/day for 8 weeks

Other: Placebo

Interventions

MS-20 DRUG

fermented soymilk product

MS-20

Placebo OTHER

No active ingredient

Placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects aged between 20 and 65 years old.
• The subject is able to provide written informed consent by himself/herself and agrees to comply with all protocol requirements.
• The subject agrees to comply with the following two requirements:
• comply with all follow-up visit requirements according to the trial protocol.
• comply with all requirement regarding fecal samples collection, storage and delivery according to the trial protocol.

You may not qualify if:

• The subject has soybean allergy.
• The subject is pregnant or lactating.
• The subject has received or is receiving chemotherapy.
• 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 .
• 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.
• The subject has received any steroids, immunosuppressant or anti-inflammation drugs within 30 days prior to visit 1.
• The subject has received probiotics or prebiotics 30 days prior to visit 1
• 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.
• Alcohol abuse, and smoking abuse.
• The subject has active inflammatory bowel disease or gastric ulcer.
• The subject currently is participating in studies involving other investigational drugs, medical devices, functional foods, or cosmetic.
• The subject is considered by the investigator as not suitable for the trial.
• The subject is judged by the investigator as not suitable for the trial due to concerns about possible non-compliance or severe concomitant illnesses.

Sponsors & Collaborators

• Microbio Co Ltd: lead

Study Sites (1)

Microbio Group

Taipei, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 19, 2020
• Study Start: October 18, 2019
• Primary Completion: September 4, 2020
• Study Completion: November 20, 2020
• Last Updated: December 23, 2020

Record last verified: 2020-12

Locations

TW (1)