Actively Recruiting
MS-20 on Patients With Ulcerative Colitis(UC)
Led by National Taiwan University Hospital · Updated on 2024-06-06
40
Participants Needed
1
Research Sites
171 weeks
Total Duration
On this page
Sponsors
N
National Taiwan University Hospital
Lead Sponsor
M
Microbio Co Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a small pilot study of the fermented soybean extract MicrSoy-20(MS-20) to confirm its ability to improve UC severity with the treatment of standard therapies. The primary endpoint, structural alteration of gut microbiota during the trial will be analyzed. Secondary endpoints aim to observe the changes of partial Mayo score, patient response of medication of UC treatments, biomarker changes in blood, and safety after taking MS-20.
CONDITIONS
Official Title
MS-20 on Patients With Ulcerative Colitis(UC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged between 20 and 65 years with confirmed moderate to severe Ulcerative Colitis (partial Mayo score 63)
- Diagnosis of ulcerative colitis for at least 3 months before screening
- Females with childbearing potential must agree to abstain from sexual intercourse or use effective contraception during the trial
- Willing and able to comply with study visits and procedures
- Able to collect, store with refrigeration, and deliver stool samples from home
You will not qualify if you...
- Allergy to soybean or soybean products
- History of HIV infection or decline to disclose HIV status
- Unable to take oral drugs or have gastrointestinal history/surgery affecting oral drug absorption
- History of Crohn's disease
- Use of antibiotics, antifungal, or antiviral drugs (excluding topical skin medication) within 30 days before screening
- Use of probiotics, prebiotics, or Chinese medicine products within 14 days before screening
- Diarrhea from gastrointestinal infection within 14 days before screening (UC-related diarrhea allowed)
- Pregnant, breastfeeding, or expecting to breastfeed women
- Abnormal lab results: AST or ALT >3 times upper limit, total bilirubin 63 times upper limit, serum creatinine >2 times upper limit
- History of malignant tumors within 5 years except for certain cured cancers
- History of drug or alcohol addiction preventing trial completion
- Participation in other clinical trials within 30 days before screening
- History of Clostridium difficile infection
- Travel abroad for more than 10 days in 30 days before or during the study
- Investigator judges subject not suitable for participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Taiwan University Hospital
Taipei, Taiwan, 100
Actively Recruiting
Research Team
Y
Yen-Hsuan Ni
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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