Metabolic SyndromeNCT06183801
Effects of Probiotics on Metabolic Syndrome ,Intestinal Microflora and SCFA.
A study testing Probiotics 1, Probiotics 2 and Probiotics 3 in people with Metabolic Syndrome, run by Glac Biotech Co., Ltd at 1 site in Taiwan.
Trial summary
The improvement effects of GLAC biotech probiotics contains 5 specialized strains on the biochemical analysis and gut microbiota will be verified in the clinical trial through cooperation with the ADPRC. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Probiotics 1, Probiotics 2 and Probiotics 3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2021to 31 Mar 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The subject are willing to provide physical examination reports within the past 1 year.
- The subject are willing to sign informed consent form.
Who cannot join
- Pregnant women or preparing for pregnancy.
- The subject were taking antibiotics.
- One of parents are not Han Chinese or aboriginal.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: GLAC Metabolic Regulatory Probiotics, the Evaluation to Improve the Human Metabolic Syndrome, Intestinal Microflora and Short Chain Fatty Acid.
The improvement effects of GLAC biotech probiotics contains 5 specialized strains on the biochemical analysis and gut microbiota will be verified in the clinical trial through cooperation with the ADPRC. Through this project, the difference and improvement before and after the GLAC biotech probiotics taking will be clinically validated fromseveral aspects, including blood biochemical values, NGS gut microbiota analysis, GAIS and SCFAs levels. Therefore, by this industry- academic cooperation project, the investigators can explore the improvement of human gut microbiota by GLAC biotech probiotics, to understand the essence of clinical benefit, and the investigators expect the accomplishments of this project can help the consumers understand the added value and excellence of the GLAC products, and thus enhance consumer confidence and expand product markets.
Read the detailed description
In recent years, the issue of gut microbiota and probiotics has been becoming very popular, and more and more gastrointestinal health foods have been developed and commercialized. The impact of gut microbiota on human health has received increasing attention and expectations from the world. Probiotics are one of the most recognized and positive health materials for consumers. Lactobacillus/probiotics, the main raw materials of health foods most frequently purchased by domestic consumers in recent years, have always ranked the first. They have certain improvement effects in terms of gastrointestinal improvement, immune regulation, and blood lipid regulation. There are currently about 30 probiotic manufacturers in Taiwan. Since the regulations do not have any clinical functional requirements for probiotic products, most probiotic products only describe the characteristics, functions and animal experiments of probiotics. There is no actual clinical experimental data to verify the effect of probiotic products on human intestinal flora. The probiotics researched and developed by GLAC Biotechnology company have undergone rigorous in vitro and animal tests, and actively cooperate with domestic and foreign hospitals to conduct human clinical trials to verify the function of the strains.
With the progress of human culture and lifestyle, many diseases of modern civilization have emerged one after another. Most of these diseases are caused by changes of lifestyle or diet, leading to the human body's metabolic imbalances, such as high blood sugar, high cholesterol, hypertension, hyperuricemia, liver dysfunction, and obesity. Gut dysbiosis and diseases associated with aging usually have such phenomenon like increased pathogenic bacteria, decreased probiotics decrease and declined gut microbiota diversity. The gut dysbiosis contributes to the aging gut and aging-related diseases in at least three aspects including production of Lipopolysaccharides (LPS), reduced levels of short chain fatty acids (SCFAs), and inflamm-aging. The next generation sequencing (NGS) technology can provide high throughput, high sensitivity and reliable detection, and then the investigators can understand improving effects of the human gut microbiota. The Aging and Disease Prevention Research Center (ADPRC) of the Fooyin university has a complete and skilled next generation sequencing (NGS) platform and a gut microbiota database included 5000 clinical cases, and thus provide the best clinical verification platform for probiotic products. Based on the common probiotic/pathogenic markers, reported in most of studies, and 4 specific domestic markers found in our study, the investigators have defined the domestic gut aging index score (GAIS) to predict the aging of the gut. The GASI provides an excellent discrimination. In addition, gut microbiota normally affects inflammatory cytokines by generating SCFAs to modulate the immune system against pathogens. The improvement effects of GLAC biotech probiotics contains 5 specialized strains on the biochemical analysis and gut microbiota will be verified in the clinical trial through cooperation with the ADPRC. Through this project, the difference and improvement before and after the GLAC biotech probiotics taking will be clinically validated from several aspects, including blood biochemical values, NGS gut microbiota analysis, GAIS and SCFAs levels. Therefore, by this industry- academic cooperation project, the investigators can explore the improvement of human gut microbiota by GLAC biotech probiotics, to understand the essence of clinical benefit, and the investigators expect the accomplishments of this project can help the consumers understand the added value and excellence of the GLAC products, and thus enhance consumer confidence and expand product markets.
- Conditions
- Metabolic Syndrome
- Being tested
- Probiotics 1, Probiotics 2, Probiotics 3, Probiotics 4, Probiotics 5
- Keywords
- Probiotics, Gut microbiota, Metabolic imbalances, SCFAs
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotics 1Dietary supplement
Subjects take probiotics capsule(Lactobacillus fermentum,TSF331) three times a day before meal.
Probiotics 2Dietary supplement
Subjects take probiotics capsule(Lactobacillus reuteri,TSR332) three times a day before meal.
Probiotics 3Dietary supplement
Subjects take probiotics capsule(Lactobacillus plantarum,TSP05) three times a day before meal.
Probiotics 4Dietary supplement
Subjects take probiotics capsule(Lactobacillus fermentum,TSF331+Lactobacillus reuteri,TSR332+Lactobacillus plantarum,TSP05) three times a day before meal.
Probiotics 5Dietary supplement
Subjects take probiotics capsule(Lactobacillus fermentum,TSF331+Lactobacillus reuteri,TSR332+Lactobacillus plantarum,TSP05+Postbiotics PE0401) three times a day before meal.
Placebo 1Dietary supplement
Subjects take capsule three times a day before meal.
Probiotics 6Dietary supplement
After 1 month wash out, subjects take probiotics capsule(Bifidobacterium animalis subsp. lactis,CP-9) three times a day before meal.
Probiotics 7Dietary supplement
After 1 month wash out, subjects take probiotics capsule(Lactobacillus rhamnosus, bv-77+Bifidobacterium animalis subsp. lactis,CP-9) three times a day before meal.
Placebo 2Dietary supplement
After 1 month wash out, subjects take capsule three times a day before meal.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic 1 | Experimental | Subjects take probiotics capsule three times a day before meal. Receives: Dietary Supplement: Probiotics 1 |
| Probiotic 2 | Experimental | Subjects take probiotics capsule three times a day before meal. Receives: Dietary Supplement: Probiotics 2 |
| Probiotic 3 | Experimental | Subjects take probiotics capsule three times a day before meal. Receives: Dietary Supplement: Probiotics 3 |
| Probiotic 4 | Experimental | Subjects take probiotics capsule three times a day before meal. Receives: Dietary Supplement: Probiotics 4 |
| Probiotic 5 | Experimental | Subjects take probiotics capsule three times a day before meal. Receives: Dietary Supplement: Probiotics 5 |
| Placebo 1 | Placebo comparator | Subjects take probiotics capsule three times a day before meal. Receives: Dietary Supplement: Placebo 1 |
| Probiotic 6 | Experimental | After 1 month wash out,subjects take probiotics capsule three times a day before meal. Receives: Dietary Supplement: Probiotics 6 |
| Probiotic 7 | Experimental | After 1 month wash out,subjects take probiotics capsule three times a day before meal. Receives: Dietary Supplement: Probiotics 7 |
| Placebo 2 | Placebo comparator | After 1 month wash out,subjects take probiotics capsule three times a day before meal. Receives: Dietary Supplement: Placebo 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood biochemical indicators
Detecting the changes of concentration in blood biochemical indexes .
- glucose AC (mg/dL)
- Glutamic Oxaloacetic Transaminase,GOT (U/L)
- Glutamic Pyruvic Transaminase,GPT (U/L)
- Blood urea nitrogen,BUN (mg/dL)
- Creatinine (mg/dL)
- Triglyceride,TG (mg/dL)
- total cholesterol (mg/dL)
- High-density lipoprotein,HDL (mg/dL)
- Low-density lipoprotein,LDL (mg/dL)
Measured: Day0、Day30、Day60、Day90、Day120、Day180
Changes in gut microbiota ratios
Using Next-Generation Sequencing (NGS) to analyze the changes of fecal flora.
Measured: Day0、Day30、Day60、Day90、Day120、Day180
Changes in gut aging index score(GAIS)
Calculating probiotic/pathogenic ratios
Measured: Day0、Day30、Day60、Day90、Day120、Day180
Secondary outcomes (5)
Short chain fatty acid analysis
Changerate of short chain fatty acid in stool
Measured: Day0、Day30、Day60、Day90、Day120、Day180
Changes in sleep quality
PITTSBURGH SLEEP QUALITY INDEX (PSQI):The minimum value is "0" and maximum value is "72", higher scores mean a worse outcome.
The change in score will be evaluated.
Measured: Day0、Day30、Day60、Day90、Day120、Day180
Evaluating the score difference of Gastrointestinal(GI) symptoms questionnaire
Gastrointestinal(GI) symptoms questionnaire:The minimum value is "0" and maximum value is "30", higher scores mean a worse outcome.The change in score will be evaluated.
Measured: Day0、Day30、Day60、Day90、Day120、Day180
Evaluating the score difference of Physical symptoms questionnaire
Physical symptoms questionnaire:The minimum value is "0" and maximum value is "75", higher scores mean a worse outcome.The change in score will be evaluated.
Measured: Day0、Day30、Day60、Day90、Day120、Day180
Changes in stool form
Record the stool form and color.Types 1 and 2 indicate constipation, with 3 and 4 being the ideal stools as they are easy to defecate while not containing excess liquid, 5 indicating lack of dietary fiber, and 6 and 7 indicate diarrhoea.(Type 1: Separate hard lumps, like nuts (difficult to pass)、Type 2: Sausage-shaped, but lumpy、Type 3: Like a sausage but with cracks on its surface、Type 4: Like a sausage or snake, smooth and soft (average stool)、Type 5: Soft blobs with clear cut edges、Type 6: Fluffy pieces with ragged edges, a mushy stool (diarrhea)、Type 7: Watery, no solid pieces, entirely liquid (diarrhea))
Measured: Day0、Day30、Day60、Day90、Day120、Day180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start1 Aug 2021
- Primary completion30 Sep 2022
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies 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
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Hsieh-Hsun Ho, Glac Biotech Co., Ltd
- Investigators
- Hsieh-Hsun Ho, Ph. D., Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06183801
- Sponsor's protocol ID
- FYH-IRB-110-01-02
- Status last verified
- Dec 2023
- First submitted
- 4 Dec 2023
- Last updated
- 28 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lin JH, Lin CH, Kuo YW, Liao CA, Chen JF, Tsai SY, Li CM, Hsu YC, Huang YY, Hsia KC, Yeh YT, Ho HH. Probiotic Lactobacillus fermentum TSF331, Lactobacillus reuteri TSR332, and Lactobacillus plantarum TSP05 improved liver function and uric acid management-A pilot study. PLoS One. 2024 Jul 24;19(7):e0307181. doi: 10.1371/journal.pone.0307181. eCollection 2024.
PubMed 39046973
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GLAC Metabolic Regulatory Probiotics, the Evaluation to Improve the Human Metabolic Syndrome, Intestinal Microflora and Short Chain Fatty Acid.
- ClinicalTrials.gov ID
- NCT06183801
- Acronym / sponsor ID
- FYH-IRB-110-01-02
- Conditions
- Metabolic Syndrome
- Keywords
- Probiotics, Gut microbiota, Metabolic imbalances, SCFAs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Glac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 28 Dec 2023 (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 improvement effects of GLAC biotech probiotics contains 5 specialized strains on the biochemical analysis and gut microbiota will be verified in the clinical trial through cooperation with the ADPRC. Through this project, the difference and improvement before and after the GLAC biotech probiotics taking will be clinically validated fromseveral aspects, including blood biochemical values, NGS gut microbiota analysis, GAIS and SCFAs levels. Therefore, by this industry- academic cooperation project, the investigators can explore the improvement of human gut microbiota by GLAC biotech probiotics, to understand the essence of clinical benefit, and the investigators expect the accomplishments of this project can help the consumers understand the added value and excellence of the GLAC products, and thus enhance consumer confidence and expand product markets.
Detailed description
In recent years, the issue of gut microbiota and probiotics has been becoming very popular, and more and more gastrointestinal health foods have been developed and commercialized. The impact of gut microbiota on human health has received increasing attention and expectations from the world. Probiotics are one of the most recognized and positive health materials for consumers. Lactobacillus/probiotics, the main raw materials of health foods most frequently purchased by domestic consumers in recent years, have always ranked the first. They have certain improvement effects in terms of gastrointestinal improvement, immune regulation, and blood lipid regulation. There are currently about 30 probiotic manufacturers in Taiwan. Since the regulations do not have any clinical functional requirements for probiotic products, most probiotic products only describe the characteristics, functions and animal experiments of probiotics. There is no actual clinical experimental data to verify the effect of probiotic products on human intestinal flora. The probiotics researched and developed by GLAC Biotechnology company have undergone rigorous in vitro and animal tests, and actively cooperate with domestic and foreign hospitals to conduct human clinical trials to verify the function of the strains.
With the progress of human culture and lifestyle, many diseases of modern civilization have emerged one after another. Most of these diseases are caused by changes of lifestyle or diet, leading to the human body's metabolic imbalances, such as high blood sugar, high cholesterol, hypertension, hyperuricemia, liver dysfunction, and obesity. Gut dysbiosis and diseases associated with aging usually have such phenomenon like increased pathogenic bacteria, decreased probiotics decrease and declined gut microbiota diversity. The gut dysbiosis contributes to the aging gut and aging-related diseases in at least three aspects including production of Lipopolysaccharides (LPS), reduced levels of short chain fatty acids (SCFAs), and inflamm-aging. The next generation sequencing (NGS) technology can provide high throughput, high sensitivity and reliable detection, and then the investigators can understand improving effects of the human gut microbiota. The Aging and Disease Prevention Research Center (ADPRC) of the Fooyin university has a complete and skilled next generation sequencing (NGS) platform and a gut microbiota database included 5000 clinical cases, and thus provide the best clinical verification platform for probiotic products. Based on the common probiotic/pathogenic markers, reported in most of studies, and 4 specific domestic markers found in our study, the investigators have defined the domestic gut aging index score (GAIS) to predict the aging of the gut. The GASI provides an excellent discrimination. In addition, gut microbiota normally affects inflammatory cytokines by generating SCFAs to modulate the immune system against pathogens. The improvement effects of GLAC biotech probiotics contains 5 specialized strains on the biochemical analysis and gut microbiota will be verified in the clinical trial through cooperation with the ADPRC. Through this project, the difference and improvement before and after the GLAC biotech probiotics taking will be clinically validated from several aspects, including blood biochemical values, NGS gut microbiota analysis, GAIS and SCFAs levels. Therefore, by this industry- academic cooperation project, the investigators can explore the improvement of human gut microbiota by GLAC biotech probiotics, to understand the essence of clinical benefit, and the investigators expect the accomplishments of this project can help the consumers understand the added value and excellence of the GLAC products, and thus enhance consumer confidence and expand product markets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Probiotic 1 | Experimental | Dietary Supplement: Probiotics 1Subjects take probiotics capsule three times a day before meal. |
| Probiotic 2 | Experimental | Dietary Supplement: Probiotics 2Subjects take probiotics capsule three times a day before meal. |
| Probiotic 3 | Experimental | Dietary Supplement: Probiotics 3Subjects take probiotics capsule three times a day before meal. |
| Probiotic 4 | Experimental | Dietary Supplement: Probiotics 4Subjects take probiotics capsule three times a day before meal. |
| Probiotic 5 | Experimental | Dietary Supplement: Probiotics 5Subjects take probiotics capsule three times a day before meal. |
| Placebo 1 | Placebo comparator | Dietary Supplement: Placebo 1Subjects take probiotics capsule three times a day before meal. |
| Probiotic 6 | Experimental | Dietary Supplement: Probiotics 6After 1 month wash out,subjects take probiotics capsule three times a day before meal. |
| Probiotic 7 | Experimental | Dietary Supplement: Probiotics 7After 1 month wash out,subjects take probiotics capsule three times a day before meal. |
| Placebo 2 | Placebo comparator | Dietary Supplement: Placebo 2After 1 month wash out,subjects take probiotics capsule three times a day before meal. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- The subject are willing to provide physical examination reports within the past 1 year.
- The subject are willing to sign informed consent form.
Key exclusion criteria (3 listed)
- Pregnant women or preparing for pregnancy.
- The subject were taking antibiotics.
- One of parents are not Han Chinese or aboriginal.
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 |
|---|---|---|
| Probiotics 1Subjects take probiotics capsule(Lactobacillus fermentum,TSF331) three times a day before meal. | Dietary supplement | Probiotic 1 |
| Probiotics 2Subjects take probiotics capsule(Lactobacillus reuteri,TSR332) three times a day before meal. | Dietary supplement | Probiotic 2 |
| Probiotics 3Subjects take probiotics capsule(Lactobacillus plantarum,TSP05) three times a day before meal. | Dietary supplement | Probiotic 3 |
| Probiotics 4Subjects take probiotics capsule(Lactobacillus fermentum,TSF331+Lactobacillus reuteri,TSR332+Lactobacillus plantarum,TSP05) three times a day before meal. | Dietary supplement | Probiotic 4 |
| Probiotics 5Subjects take probiotics capsule(Lactobacillus fermentum,TSF331+Lactobacillus reuteri,TSR332+Lactobacillus plantarum,TSP05+Postbiotics PE0401) three times a day before meal. | Dietary supplement | Probiotic 5 |
| Placebo 1Subjects take capsule three times a day before meal. | Dietary supplement | Placebo 1 |
| Probiotics 6After 1 month wash out, subjects take probiotics capsule(Bifidobacterium animalis subsp. lactis,CP-9) three times a day before meal. | Dietary supplement | Probiotic 6 |
| Probiotics 7After 1 month wash out, subjects take probiotics capsule(Lactobacillus rhamnosus, bv-77+Bifidobacterium animalis subsp. lactis,CP-9) three times a day before meal. | Dietary supplement | Probiotic 7 |
| Placebo 2After 1 month wash out, subjects take capsule three times a day before meal. | Dietary supplement | Placebo 2 |
Primary outcome
blood biochemical indicators
Time frame: Day0、Day30、Day60、Day90、Day120、Day180
Detecting the changes of concentration in blood biochemical indexes . 1. glucose AC (mg/dL) 2. Glutamic Oxaloacetic Transaminase,GOT (U/L) 3. Glutamic Pyruvic Transaminase,GPT (U/L) 4. Blood urea nitrogen,BUN (mg/dL) 5. Creatinine (mg/dL) 6. Triglyceride,TG (mg/dL) 7. total cholesterol (mg/dL) 8. High-density lipoprotein,HDL (mg/dL) 9. Low-density lipoprotein,LDL (mg/dL)
Changes in gut microbiota ratios
Time frame: Day0、Day30、Day60、Day90、Day120、Day180
Using Next-Generation Sequencing (NGS) to analyze the changes of fecal flora.
Changes in gut aging index score(GAIS)
Time frame: Day0、Day30、Day60、Day90、Day120、Day180
Calculating probiotic/pathogenic ratios
5 secondary outcomes
Short chain fatty acid analysis
Time frame: Day0、Day30、Day60、Day90、Day120、Day180
Changes in sleep quality
Time frame: Day0、Day30、Day60、Day90、Day120、Day180
Evaluating the score difference of Gastrointestinal(GI) symptoms questionnaire
Time frame: Day0、Day30、Day60、Day90、Day120、Day180
Evaluating the score difference of Physical symptoms questionnaire
Time frame: Day0、Day30、Day60、Day90、Day120、Day180
Changes in stool form
Time frame: Day0、Day30、Day60、Day90、Day120、Day180
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 28 Dec 2023.
- Derived from this study: PubMed 39046973Lin JH, Lin CH, Kuo YW, Liao CA, Chen JF, Tsai SY, Li CM, Hsu YC, Huang YY, Hsia KC, Yeh YT, Ho HH. Probiotic Lactobacillus fermentum TSF331, Lactobacillus reuteri TSR332, and Lactobacillus plantarum TSP05 improved liver function and uric acid management-A pilot study. PLoS One. 2024 Jul 24;19(7):e0307181. doi: 10.1371/journal.pone.0307181. eCollection 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.
Hsieh-Hsun Ho, Ph. D. principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics 1, Probiotics 2 and Probiotics 3 in people with Metabolic Syndrome, run by Glac Biotech 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 2 inclusion and 3 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 28 Dec 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. 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?
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?
blood biochemical indicators (time frame: Day0、Day30、Day60、Day90、Day120、Day180). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06183801, which also lists 1 linked publication.
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 28 Dec 2023.