Using MS-20 to treat Ulcerative Colitis

Study to Evaluate Efficacy and Safety of MS 20 on Patients With Ulcerative Colitis

This study is testing if a fermented soybean extract called MS-20 can help people with moderate to severe Ulcerative Colitis feel better when taken with their usual treatments.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 20 Years to 65 Years
• Sex: All
• Sponsor: National Taiwan University Hospital (other)
• Locations: 1 site (Taipei)
• Trial ID: NCT04908644 on ClinicalTrials.gov

What this trial studies

This pilot study evaluates the effects of a fermented soybean extract, MicrSoy-20 (MS-20), on patients with moderate to severe Ulcerative Colitis (UC) alongside standard therapies. The primary focus is to analyze changes in gut microbiota structure, while secondary endpoints include assessing the partial Mayo score, medication response, blood biomarker changes, and safety of MS-20. Participants will receive either the MS-20 oral solution or a placebo during the trial.

Who should consider this trial

Good fit: Ideal candidates are males and females aged 20 to 65 with a confirmed diagnosis of moderate to severe Ulcerative Colitis.

Not a fit: Patients with mild Ulcerative Colitis or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for improving the severity of Ulcerative Colitis.

How similar studies have performed: While this approach is novel, similar studies exploring gut microbiota modulation have shown promising results.

Eligibility criteria

Inclusion Criteria:

1. Male or female subject aged between 20 and 65 years old who has confirmed diagnosis of moderate to severe Ulcerative Colitis (UC): partial Mayo score≧3.
2. Subject has established diagnosis of ulcerative colitis for≧3 months prior to screening.
3. Females with childbearing potential must agree to completely abstain from sexual intercourse or use adequate contraceptive methods such as IUD or birth control pills during the trial period. \[Definition of infertility: (1) Menopause for at least 1 year; (2) Has undergone surgical ligation, such as hysterectomy, bilateral oophorectomy, or fallopian tube ligation; (3) Congenital structural abnormalities.
4. As judged by the investigators, subject who is proactive, have the ability to communicate with study staff, and capable and willing to cooperate two points below,

   1. be willing and able to comply with the subject visit arrangements and procedures defined in the protocol.
   2. to collect, store with adequate refrigerating facilities and delivery of stool samples from home.

Exclusion Criteria:

1. Subject who is allergic to soybean and its products.
2. Subject who has a history of human immunodeficiency virus (HIV) infection. (Through oral disclosure and medical records by the doctor, subject who decline to disclose will be excluded)
3. Subject cannot take drugs orally or have any gastrointestinal history or surgery which investigator believes may affect the absorption of the oral investigational product.
4. Subject who has known history of Crohn's disease
5. Subject who has used antibiotics, antifungal or antiviral drugs (not including skin topical medication) within 30 days before the screening visit.
6. Subject who has used probiotics and prebiotics-related products within 14 days before the screening visit (e.g., yogurt drink, yogurt, Yakult, Wakamoto tablets, Shin Biofermin S tablets, probiotic powder, fermented beverages, tablets, capsules, inulin, oligosaccharide products, etc.).
7. Subject who has used Chinese medicine or products containing such ingredients within 14 days before the screening visit.
8. Subject who had diarrhea caused by gastrointestinal infections within14 days before the screening visit (more than three soft or watery stools within 24 hours). Ulcerative colitis-induced diarrhea is unrestricted.
9. Woman who is pregnant, breastfeeding, or expect to breastfeed during the study period.
10. Subject who has any of the following abnormalities of biochemical lab results: AST or ALT (\> 3 × upper limit of normal \[ULN\]) or higher; Total bilirubin ≥ 3 x ULN; Serum creatinine\> 2 × ULN.
11. Subject who has a history of malignant tumors within five years before the screening visit, except for locally curable cancers that have been clearly cured, such as basal or squamous-cell carcinoma, superficial bladder cancer, or prostate, cervix, or breast carcinoma in situ.
12. The subject has a medical history of drug or alcohol addiction that may result in the inability to complete the trial at the investigator's discretion.
13. Subject who has participated in a clinical trial of other investigational drug treatments or medical devices within 30 days before the screening visit.
14. Subject who had Clostridium difficile infection.
15. Subject who has been abroad for more than 10 days in the 30 days before the screening visit or expected to go abroad for more than 10 days during the trial period.
16. The investigator judges that the subject is not suitable for participating in the trial.

Where this trial is running

Taipei

• National Taiwan University Hospital — Taipei, Taiwan (RECRUITING)

Study contacts

• Study coordinator: Yen-Hsuan Ni

Conditions: Ulcerative Colitis, MS-20, Postbiotics, Gut microbiota