MS-20 on Patients With Ulcerative Colitis(UC)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Other: Placebo; Drug: MS-20 oral solution

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yen-Hsuan Ni; Phone Number: 71516 +886-2-23123456; Email: mbclinical@microbio.com.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Phone Number: 866-2-23123456

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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≧5.
2. The subject must be informed and able to sign the informed consent form.
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. Male subjects must agree to avoid donating sperm during the period of receiving the investigational product, and completely abstain from sexual intercourse or use appropriate contraceptive methods such as condoms.

5. 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 received any immunoglobulin product or blood product within 3 months before the day of blood draw.
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) or those who had C. difficile infection.
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 ≥ 1.5 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 has participated in a weight control program within 60 days before the screening visit.
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: MS-20 oral solution; Oral Solution 8 c.c per day divided twice daily (BID) for 12 weeks.	Drug: MS-20 oral solution; Fermented soybean extract MicrSoy-20(MS-20), which uses a variety of lactic acid bacteria and yeasts to metabolize organic soybeans; Other Names: Chemo young
PLACEBO_COMPARATOR: Placebo; Oral Solution 8 c.c per day divided twice daily (BID) for 12 weeks.	Other: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline structural of gut microbiota at 16 weeks	Baseline, week 16
Change from baseline in the abundance and variability of gut microbiota at 16 weeks	Baseline, week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline of Partial Mayo Score at 12 weeks	Partial Mayo score consisted of 3 sub-scores: stool frequency, most severe rectal bleeding of the day, endoscopic findings and global assessment by physician, each graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9. Here, higher scores indicated more severe disease.	Baseline, week 12
Change from baseline of IL-6 level in blood at 12 weeks		Baseline, week 12
Change from baseline of TNF-α level in blood at 12 weeks		Baseline, week 12
Change from baseline of IL-1β level in blood at 12 weeks		Baseline, week 12
Change from baseline of IL-23 level in blood at 12 weeks		Baseline, week 12
Change from baseline of IL-33 level in blood at 12 weeks		Baseline, week 12
Change from baseline of C-reactive protein(CRP) level in blood at 12 weeks		Baseline, week 12
Change from baseline of erythrocyte sedimentation rate(ESR) at 12 weeks		Baseline, week 12
Change from baseline of fecal calprotectin result at 12 weeks		Baseline, week 12
Change from baseline of fecal occult blood result at 12 weeks		Baseline, week 12
Adverse events		up to 16 weeks

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: Microbio Co Ltd

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 18, 2021
• Primary Completion (ANTICIPATED): June 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: May 25, 2021
• First Submitted That Met QC Criteria: May 27, 2021
• First Posted (ACTUAL): June 1, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 13, 2022
• Last Update Submitted That Met QC Criteria: June 10, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Ulcerative Colitis; Gut microbiota; Postbiotics; MS-20
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: 202006118MIPB; MB103CLAS07 (OTHER: protocol No.)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No