Ulcerative ColitisNCT04908644
MS-20 on Patients With Ulcerative Colitis(UC)
A study testing MS-20 oral solution in people with Ulcerative Colitis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- MS-20 oral solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 Aug 2021to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.).
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- 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.
- The investigator judges that the subject is not suitable for participating in the trial.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
866-2-23123456
About this study
Official title: 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.
- Conditions
- Ulcerative Colitis
- Being tested
- MS-20 oral solution, Placebo
- Keywords
- Ulcerative Colitis, MS-20, Postbiotics, Gut microbiota
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MS-20 oral solutionDrug
Also called Chemo young
Fermented soybean extract MicrSoy-20(MS-20), which uses a variety of lactic acid bacteria and yeasts to metabolize organic soybeans
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| MS-20 oral solution | Experimental | Oral Solution 8 c.c per day divided twice daily (BID) for 12 weeks. Receives: Drug: MS-20 oral solution |
| Placebo | Placebo comparator | Oral Solution 8 c.c per day divided twice daily (BID) for 12 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline structural of gut microbiota at 16 weeks
Measured: Baseline, week 16
Change from baseline in the abundance and variability of gut microbiota at 16 weeks
Measured: Baseline, week 16
Secondary outcomes (11)
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.
Measured: Baseline, week 12
Change from baseline of IL-6 level in blood at 12 weeks
Measured: Baseline, week 12
Change from baseline of TNF-α level in blood at 12 weeks
Measured: Baseline, week 12
Change from baseline of IL-1β level in blood at 12 weeks
Measured: Baseline, week 12
Change from baseline of IL-23 level in blood at 12 weeks
Measured: Baseline, week 12
Change from baseline of IL-33 level in blood at 12 weeks
Measured: Baseline, week 12
Change from baseline of C-reactive protein(CRP) level in blood at 12 weeks
Measured: Baseline, week 12
Change from baseline of erythrocyte sedimentation rate(ESR) at 12 weeks
Measured: Baseline, week 12
Change from baseline of fecal calprotectin result at 12 weeks
Measured: Baseline, week 12
Change from baseline of fecal occult blood result at 12 weeks
Measured: Baseline, week 12
Adverse events
Measured: up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start18 Aug 2021
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Microbio Co Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04908644
- Sponsor's protocol ID
- 202006118MIPB
- Other IDs
- MB103CLAS07
- Status last verified
- Jun 2024
- First submitted
- 25 May 2021
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate Efficacy and Safety of MS 20 on Patients With Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT04908644
- Acronym / sponsor ID
- 202006118MIPB
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative Colitis, MS-20, Postbiotics, Gut microbiota
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Microbio Co Ltd
- Study start
- 18 Aug 2021 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 1 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MS-20 oral solution | Experimental | Drug: MS-20 oral solutionOral Solution 8 c.c per day divided twice daily (BID) for 12 weeks. |
| Placebo | Placebo comparator | Other: PlaceboOral Solution 8 c.c per day divided twice daily (BID) for 12 weeks. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MS-20 oral solutionAlso: Chemo youngFermented soybean extract MicrSoy-20(MS-20), which uses a variety of lactic acid bacteria and yeasts to metabolize organic soybeans | Drug | MS-20 oral solution |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Change 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
11 secondary outcomes
Change from baseline of Partial Mayo Score at 12 weeks
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MS-20 oral solution in people with Ulcerative Colitis, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yen-Hsuan Ni (+886-2-23123456 ext. 71516, mbclinical@microbio.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline structural of gut microbiota at 16 weeks (time frame: Baseline, week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.