Effects of Probiotics on Metabolic Syndrome ,Intestinal Microflora and SCFA.
NCT ID: NCT06183801
Last Updated: 2023-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
82 participants
INTERVENTIONAL
2021-08-01
2023-03-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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Probiotic 1
Subjects take probiotics capsule three times a day before meal.
Probiotics 1
Subjects take probiotics capsule(Lactobacillus fermentum,TSF331) three times a day before meal.
Probiotic 2
Subjects take probiotics capsule three times a day before meal.
Probiotics 2
Subjects take probiotics capsule(Lactobacillus reuteri,TSR332) three times a day before meal.
Probiotic 3
Subjects take probiotics capsule three times a day before meal.
Probiotics 3
Subjects take probiotics capsule(Lactobacillus plantarum,TSP05) three times a day before meal.
Probiotic 4
Subjects take probiotics capsule three times a day before meal.
Probiotics 4
Subjects take probiotics capsule(Lactobacillus fermentum,TSF331+Lactobacillus reuteri,TSR332+Lactobacillus plantarum,TSP05) three times a day before meal.
Probiotic 5
Subjects take probiotics capsule three times a day before meal.
Probiotics 5
Subjects take probiotics capsule(Lactobacillus fermentum,TSF331+Lactobacillus reuteri,TSR332+Lactobacillus plantarum,TSP05+Postbiotics PE0401) three times a day before meal.
Placebo 1
Subjects take probiotics capsule three times a day before meal.
Placebo 1
Subjects take capsule three times a day before meal.
Probiotic 6
After 1 month wash out,subjects take probiotics capsule three times a day before meal.
Probiotics 6
After 1 month wash out, subjects take probiotics capsule(Bifidobacterium animalis subsp. lactis,CP-9) three times a day before meal.
Probiotic 7
After 1 month wash out,subjects take probiotics capsule three times a day before meal.
Probiotics 7
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 2
After 1 month wash out,subjects take probiotics capsule three times a day before meal.
Placebo 2
After 1 month wash out, subjects take capsule three times a day before meal.
Interventions
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Probiotics 1
Subjects take probiotics capsule(Lactobacillus fermentum,TSF331) three times a day before meal.
Probiotics 2
Subjects take probiotics capsule(Lactobacillus reuteri,TSR332) three times a day before meal.
Probiotics 3
Subjects take probiotics capsule(Lactobacillus plantarum,TSP05) three times a day before meal.
Probiotics 4
Subjects take probiotics capsule(Lactobacillus fermentum,TSF331+Lactobacillus reuteri,TSR332+Lactobacillus plantarum,TSP05) three times a day before meal.
Probiotics 5
Subjects take probiotics capsule(Lactobacillus fermentum,TSF331+Lactobacillus reuteri,TSR332+Lactobacillus plantarum,TSP05+Postbiotics PE0401) three times a day before meal.
Placebo 1
Subjects take capsule three times a day before meal.
Probiotics 6
After 1 month wash out, subjects take probiotics capsule(Bifidobacterium animalis subsp. lactis,CP-9) three times a day before meal.
Probiotics 7
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 2
After 1 month wash out, subjects take capsule three times a day before meal.
Eligibility Criteria
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Inclusion Criteria
2. The subject are willing to sign informed consent form.
Exclusion Criteria
2. The subject were taking antibiotics.
3. One of parents are not Han Chinese or aboriginal.
ALL
No
Sponsors
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Glac Biotech Co., Ltd
INDUSTRY
Responsible Party
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Hsieh-Hsun Ho
R & D director
Principal Investigators
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Hsieh-Hsun Ho, Ph. D.
Role: PRINCIPAL_INVESTIGATOR
Study Principal Investigator
Locations
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Glac Biotech Co., Ltd.
Tainan City, , Taiwan
Countries
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References
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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.
Other Identifiers
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FYH-IRB-110-01-02
Identifier Type: -
Identifier Source: org_study_id