MS-20 on Patients With Ulcerative Colitis(UC)

NCT04908644 | Recruiting

• 2 other identifiers: 202006118MIPBMB103CLAS07
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Ulcerative Colitis

Keywords

Ulcerative Colitis; MS-20; Postbiotics; Gut microbiota

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Change from baseline of Partial Mayo Score at 12 weeks

  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

Study Arms (2)

MS-20 oral solution

EXPERIMENTAL

Oral Solution 8 c.c per day divided twice daily (BID) for 12 weeks.

Drug: MS-20 oral solution

Placebo

PLACEBO COMPARATOR

Oral Solution 8 c.c per day divided twice daily (BID) for 12 weeks.

Other: Placebo

Interventions

MS-20 oral solution DRUG

Fermented soybean extract MicrSoy-20(MS-20), which uses a variety of lactic acid bacteria and yeasts to metabolize organic soybeans

Also known as: Chemo young

MS-20 oral solution

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Subject has established diagnosis of ulcerative colitis for≧3 months prior to screening.
• 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.
• 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,
• be willing and able to comply with the subject visit arrangements and procedures defined in the protocol.
• to collect, store with adequate refrigerating facilities and delivery of stool samples from home.

You may not qualify if:

• Subject who is allergic to soybean and its products.
• 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)
• Subject cannot take drugs orally or have any gastrointestinal history or surgery which investigator believes may affect the absorption of the oral investigational product.
• Subject who has known history of Crohn's disease
• Subject who has used antibiotics, antifungal or antiviral drugs (not including skin topical medication) within 30 days before the screening visit.
• 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.).
• Subject who has used Chinese medicine or products containing such ingredients within 14 days before the screening visit.
• 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.
• Woman who is pregnant, breastfeeding, or expect to breastfeed during the study period.
• 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.
• 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.
• 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.
• Subject who has participated in a clinical trial of other investigational drug treatments or medical devices within 30 days before the screening visit.
• Subject who had Clostridium difficile infection.
• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Microbio Co Ltd: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Yen-Hsuan Ni

CONTACT

+886-2-23123456; mbclinical@microbio.com.tw

Study Design

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

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: June 1, 2021
• Study Start: August 18, 2021
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: June 6, 2024

Record last verified: 2024-06

Locations

TW (1)