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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
40
Fermented soybean extract MicrSoy-20(MS-20), which uses a variety of lactic acid bacteria and yeasts to metabolize organic soybeans
Placebo
National Taiwan University Hospital
Taipei, Taiwan
RECRUITINGChange from baseline structural of gut microbiota at 16 weeks
Time frame: Baseline, week 16
Change from baseline in the abundance and variability of gut microbiota at 16 weeks
Time frame: Baseline, week 16
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.
Time frame: Baseline, week 12
Change from baseline of IL-6 level in blood at 12 weeks
Time frame: Baseline, week 12
Change from baseline of TNF-α level in blood at 12 weeks
Time frame: Baseline, week 12
Change from baseline of IL-1β level in blood at 12 weeks
Time frame: Baseline, week 12
Change from baseline of IL-23 level in blood at 12 weeks
Time frame: Baseline, week 12
Change from baseline of IL-33 level in blood at 12 weeks
Time frame: Baseline, week 12
Change from baseline of C-reactive protein(CRP) level in blood at 12 weeks
Time frame: Baseline, week 12
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Change from baseline of erythrocyte sedimentation rate(ESR) at 12 weeks
Time frame: Baseline, week 12
Change from baseline of fecal calprotectin result at 12 weeks
Time frame: Baseline, week 12
Change from baseline of fecal occult blood result at 12 weeks
Time frame: Baseline, week 12
Adverse events
Time frame: up to 16 weeks