Type-II DiabetesNCT04639492
Postbiotic MBS and Metformin Combination in Patients With T2DM
A study testing MBS oral solution in people with Type-II Diabetes, run by Microbio Co Ltd at 1 site in Taiwan.
Trial summary
The primary objective is to evaluate the effect of MBS treatment in human subjects, and to validate its impact on intestinal flora and diabetes symptoms on diabetic patients undertaking metformin. The scientific data collected will be referenced for future product development. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Type-II Diabetes
- What is being tested?
- MBS oral solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Nov 2020to 23 Sep 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subject who aged from 20 to 70.
- BMI in between 18.5 and 35 kg/m2 inclusively.
- Fasting blood sugar ≥ 126 mg/dL, and confirmed diagnosis of type-II diabetes.
- 30 days prior to the screening visit (V1), HbA1c is steadily maintained in between 7-10% by medication.
- Prior to the screening visit (V1), subjects have been regularly taken 500-200 mg/day for at least 90 days.
Who cannot join
- Pregnant or breastfeeding women or female subjects plan to enter pregnancy during study period.
- Subjects who are allergic to soy or products containing it.
- At investigator's discretion, subjects are unlikely to comply with study procedures due to a history of alcohol or drug addiction.
- Subjects on vegetarian diet or other special diets (eg. Ketogenic or gluten-free diets).
- Subjects have ongoing participation in another clinical trial that involves the use of investigational drugs, medical devices, dietary supplements, and/or cosmetics.
- Subject with impaired renal function confirmed by Serum Total Bilirubin ≥ 1.5 upper limit of normal [ULN], Aspartate Transaminase/ Alanine Transaminase (AST/ALT) ≥ 2 ULN, Creatinine ≥ 2 ULN or eGFR <60 mL/min/1.73 m^2.
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- Subjects who have been diagnosed with malignant tumors within five (5) years before the screening visit (V1) with exception to subjects with topical cancer but show significant recovery following investigator's assessment, such as basal or squamous cell skin cancer, superficial bladder cancer, or prostate or cervix or carcinoma in situ of the breast.
- 30 days prior to screening visit (V1), subjects have taken antibiotics, synthetic drugs (Sulfonamides, Fluoroquinolone, etc.), anti-fungal or anti-viral medication but not limited to topical forms for use in skin application.
- Within 14 days prior to screening visit (V1), subjects have taken products or supplements that contain probiotics or prebiotics.
- Within 14 days prior to screening visit (V1), subjects experience diarrhea caused by gastrointestinal infection (3 times of watery stool within 24 hours).
- Within14 days prior to screening visit (V1), subjects have taken steroids, immunosuppressant, and/or inflammatory medicines.
- Subjects took or intend to take medications other than metformin that may affect intestinal flora within 30 days prior to screening visit, during screening period or whole trial period. Examples of this kind of medication include DPP-4 inhibitors, GLP-1 receptor agonists, acarbose, hypoglycemic sulfonamides, thiazolidinediones, SGLT2 inhibitors, and insulin.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Effect and Safety of Postbiotic MBS and Metformin Combination on Gut Microbiota and Symptom in Patients With Diabetes
The primary objective is to evaluate the effect of MBS treatment in human subjects, and to validate its impact on intestinal flora and diabetes symptoms on diabetic patients undertaking metformin. The scientific data collected will be referenced for future product development.
- Conditions
- Type-II Diabetes
- Being tested
- MBS oral solution
- Keywords
- Diabetes Mellitus (DM), diabetes, T2DM, MBS, microbial
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBS oral solutionDietary supplement
Oral BIDAC, twice a day before breakfast and dinner times
| Study group | Role | What they receive |
|---|---|---|
| MBS oral solution | Experimental | fermented soybean extract-MBS Receives: Dietary Supplement: MBS oral solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-treatment changes of intestinal flora
Post-treatment changes from baseline in microbial composition, abundance, variation of subject's intestinal flora at 4, 8, 12 weeks.
Measured: 4, 8,12 weeks post-treatment
Secondary outcomes (6)
Post-treatment changes from baseline in fasting plasma glucose at 12 weeks
Measured: 12 weeks post-treatment
Post-treatment changes from baseline in HbA1c at 12 weeks
Measured: 12 weeks post-treatment
Post-treatment changes from baseline in HOMA-IR at 12 weeks
Measured: 12 weeks post-treatment
Post-treatment changes from baseline in blood lipids composition at 12 weeks
Changes of triglyceride, high-density lipoprotein (HDL), and low-density lipoprotein (LDL)
Measured: 12 weeks post-treatment
Post-treatment changes from baseline in immune factors at 12 weeks
Changes of CRP, IL6, TNF-α expression
Measured: 12 weeks post-treatment
Incidence of treatment-emergent adverse events(TEAE)
Measured: 12 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start2 Nov 2020
- Primary completion30 Jun 2022
- Study completion23 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type-II DiabetesStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Microbio Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04639492
- Sponsor's protocol ID
- MBSCLAS01
- Status last verified
- Jan 2023
- First submitted
- 10 Nov 2020
- Last updated
- 5 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect and Safety of Postbiotic MBS and Metformin Combination on Gut Microbiota and Symptom in Patients With Diabetes
- ClinicalTrials.gov ID
- NCT04639492
- Acronym / sponsor ID
- MBSCLAS01
- Conditions
- Type-II Diabetes
- Keywords
- Diabetes Mellitus (DM), diabetes, T2DM, MBS, microbial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Microbio Co LtdIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 23 Sep 2022 (actual)
- First posted
- 20 Nov 2020 (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.
The primary objective is to evaluate the effect of MBS treatment in human subjects, and to validate its impact on intestinal flora and diabetes symptoms on diabetic patients undertaking metformin. The scientific data collected will be referenced for future product development.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MBS oral solution | Experimental | Dietary Supplement: MBS oral solutionfermented soybean extract-MBS |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subject who aged from 20 to 70.
- BMI in between 18.5 and 35 kg/m2 inclusively.
- Fasting blood sugar ≥ 126 mg/dL, and confirmed diagnosis of type-II diabetes.
- 30 days prior to the screening visit (V1), HbA1c is steadily maintained in between 7-10% by medication.
- Prior to the screening visit (V1), subjects have been regularly taken 500-200 mg/day for at least 90 days.
Key exclusion criteria (12 listed)
- Pregnant or breastfeeding women or female subjects plan to enter pregnancy during study period.
- Subjects who are allergic to soy or products containing it.
- At investigator's discretion, subjects are unlikely to comply with study procedures due to a history of alcohol or drug addiction.
- Subjects on vegetarian diet or other special diets (eg. Ketogenic or gluten-free diets).
- Subjects have ongoing participation in another clinical trial that involves the use of investigational drugs, medical devices, dietary supplements, and/or cosmetics.
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 |
|---|---|---|
| MBS oral solutionOral BIDAC, twice a day before breakfast and dinner times | Dietary supplement | MBS oral solution |
Primary outcome
Post-treatment changes of intestinal flora
Time frame: 4, 8,12 weeks post-treatment
Post-treatment changes from baseline in microbial composition, abundance, variation of subject's intestinal flora at 4, 8, 12 weeks.
6 secondary outcomes
Post-treatment changes from baseline in fasting plasma glucose at 12 weeks
Time frame: 12 weeks post-treatment
Post-treatment changes from baseline in HbA1c at 12 weeks
Time frame: 12 weeks post-treatment
Post-treatment changes from baseline in HOMA-IR at 12 weeks
Time frame: 12 weeks post-treatment
Post-treatment changes from baseline in blood lipids composition at 12 weeks
Time frame: 12 weeks post-treatment
Post-treatment changes from baseline in immune factors at 12 weeks
Time frame: 12 weeks post-treatment
Incidence of treatment-emergent adverse events(TEAE)
Time frame: 12 weeks post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBS oral solution in people with Type-II Diabetes, run by Microbio Co Ltd 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 5 inclusion and 12 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: finished, as of the sponsor's last update on 5 Jan 2023. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-treatment changes of intestinal flora (time frame: 4, 8,12 weeks post-treatment). 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 5 Jan 2023.