- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06183801
Effects of Probiotics on Metabolic Syndrome ,Intestinal Microflora and SCFA.
GLAC Metabolic Regulatory Probiotics, the Evaluation to Improve the Human Metabolic Syndrome, Intestinal Microflora and Short Chain Fatty Acid.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Tainan, Taiwan, 74442
- Glac Biotech Co., Ltd.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- The subject are willing to provide physical examination reports within the past 1 year.
- The subject are willing to sign informed consent form.
Exclusion Criteria:
- Pregnant women or preparing for pregnancy.
- The subject were taking antibiotics.
- One of parents are not Han Chinese or aboriginal.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Probiotic 1
Subjects take probiotics capsule three times a day before meal.
|
Subjects take probiotics capsule(Lactobacillus fermentum,TSF331) three times a day before meal.
|
Experimental: Probiotic 2
Subjects take probiotics capsule three times a day before meal.
|
Subjects take probiotics capsule(Lactobacillus reuteri,TSR332) three times a day before meal.
|
Experimental: Probiotic 3
Subjects take probiotics capsule three times a day before meal.
|
Subjects take probiotics capsule(Lactobacillus plantarum,TSP05) three times a day before meal.
|
Experimental: Probiotic 4
Subjects take probiotics capsule three times a day before meal.
|
Subjects take probiotics capsule(Lactobacillus fermentum,TSF331+Lactobacillus reuteri,TSR332+Lactobacillus plantarum,TSP05) three times a day before meal.
|
Experimental: Probiotic 5
Subjects take probiotics capsule three times a day before meal.
|
Subjects take probiotics capsule(Lactobacillus fermentum,TSF331+Lactobacillus reuteri,TSR332+Lactobacillus plantarum,TSP05+Postbiotics PE0401) three times a day before meal.
|
Placebo Comparator: Placebo 1
Subjects take probiotics capsule three times a day before meal.
|
Subjects take capsule three times a day before meal.
|
Experimental: Probiotic 6
After 1 month wash out,subjects take probiotics capsule three times a day before meal.
|
After 1 month wash out, subjects take probiotics capsule(Bifidobacterium animalis subsp.
lactis,CP-9) three times a day before meal.
|
Experimental: Probiotic 7
After 1 month wash out,subjects take probiotics capsule three times a day before meal.
|
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 Comparator: Placebo 2
After 1 month wash out,subjects take probiotics capsule three times a day before meal.
|
After 1 month wash out, subjects take capsule three times a day before meal.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
blood biochemical indicators
Time Frame: Day0、Day30、Day60、Day90、Day120、Day180
|
Detecting the changes of concentration in blood biochemical indexes .
|
Day0、Day30、Day60、Day90、Day120、Day180
|
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.
|
Day0、Day30、Day60、Day90、Day120、Day180
|
Changes in gut aging index score(GAIS)
Time Frame: Day0、Day30、Day60、Day90、Day120、Day180
|
Calculating probiotic/pathogenic ratios
|
Day0、Day30、Day60、Day90、Day120、Day180
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Short chain fatty acid analysis
Time Frame: Day0、Day30、Day60、Day90、Day120、Day180
|
Changerate of short chain fatty acid in stool
|
Day0、Day30、Day60、Day90、Day120、Day180
|
Changes in sleep quality
Time Frame: Day0、Day30、Day60、Day90、Day120、Day180
|
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. |
Day0、Day30、Day60、Day90、Day120、Day180
|
Evaluating the score difference of Gastrointestinal(GI) symptoms questionnaire
Time Frame: Day0、Day30、Day60、Day90、Day120、Day180
|
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.
|
Day0、Day30、Day60、Day90、Day120、Day180
|
Evaluating the score difference of Physical symptoms questionnaire
Time Frame: Day0、Day30、Day60、Day90、Day120、Day180
|
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.
|
Day0、Day30、Day60、Day90、Day120、Day180
|
Changes in stool form
Time Frame: Day0、Day30、Day60、Day90、Day120、Day180
|
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))
|
Day0、Day30、Day60、Day90、Day120、Day180
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hsieh-Hsun Ho, Ph. D., Study Principal Investigator
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FYH-IRB-110-01-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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