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| ID | Type | Description | Link |
|---|---|---|---|
| MB103CLAS07 | Other Identifier | protocol No. |
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| Name | Class |
|---|---|
| Microbio Co Ltd | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MS-20 oral solution | Experimental | Oral Solution 8 c.c per day divided twice daily (BID) for 12 weeks. |
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| Placebo | Placebo Comparator | Oral Solution 8 c.c per day divided twice daily (BID) for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
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| Measure | Description | 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 |
| 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. |
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Inclusion Criteria:
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,
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yen-Hsuan Ni | Contact | +886-2-23123456 | 71516 | mbclinical@microbio.com.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Recruiting | Taipei | 100 | Taiwan |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Placebo | Other | Placebo |
|
| 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 |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |