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This study aims to investigate the efficacy of the lactic acid bacteria "LUA probiotics" in reducing serum uric acid levels. The use of health supplements prior to the onset of gout symptoms is proposed as a preventive strategy to mitigate the development of gout and to reduce the subsequent reliance on long-term pharmacological treatments. Hyperuricemia is the presence of abnormally high levels of uric acid in the blood serum. Long-term hyperuricemia is a major factor in causing gout. In addition, hyperuricemia is associated with many diseases. Therefore, the prevention and treatment of hyperuricemia has gradually attracted attention. In recent years, studies have pointed out that whether from cell experiments or animal experiments, lactic acid bacteria (LAB) have the effect of lowering uric acid. However, there is a lack of rigorous clinical observational studies to further explore whether lactic acid bacteria really have the effect of lowering uric acid. This product "LUA Probiotics" is a probiotic developed and produced by the Longtan Branch of Grape King Biotechnology Co., Ltd. Its main ingredients include Lactobacillus reuteri (Lactobacillus reuteri), β-carotene, silicon dioxide and magnesium stearate. This product is not yet commercially available.
This study aims to investigate the efficacy of the lactic acid bacteria "LUA probiotics" in reducing serum uric acid levels. The use of health supplements prior to the onset of gout symptoms is proposed as a preventive strategy to mitigate the development of gout and to reduce the subsequent reliance on long-term pharmacological treatments. In recent years, lactic acid bacteria have gradually been recognized to have many benefits for human health, especially in regulating intestinal flora, enhancing immune function, and improving metabolism. Uric acid is a product of purine metabolism in the human body. Excessive uric acid concentration can cause hyperuricemia, which in turn increases the risk of gout attacks. The formation of hyperuricemia is related to multiple factors, including poor eating habits, genetic factors, and metabolic disorders.
As research on intestinal microbiota deepens, scientists have discovered that changes in intestinal flora may have a certain impact on metabolic diseases, including hyperuricemia. As an important type of probiotics, lactic acid bacteria have the ability to improve the structure of intestinal flora, regulate immune response and have anti-inflammatory effects. Recent studies have shown that lactic acid bacteria may play a positive role in reducing uric acid concentration in the blood through various mechanisms, such as degrading purine substances in the intestine, promoting uric acid excretion, and inhibiting uric acid production .
In addition, the function of lactic acid bacteria in regulating the intestinal environment, improving the diversity of intestinal microorganisms and promoting the growth of beneficial bacteria may also indirectly affect the metabolic process of uric acid. Therefore, exploring the potential of lactic acid bacteria in regulating uric acid concentration has become a hot topic in many current studies. These studies not only provide new insights into the health effects of lactic acid bacteria, but also provide new directions for the prevention and treatment of gout and other diseases related to abnormal uric acid.
This study will explore the potential role and mechanism of lactic acid bacteria in lowering uric acid and evaluate its feasibility as an adjuvant therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with hyperuricemia (uric acid level 7.5 mg/dL or above) | Patients with hyperuricemia (uric acid level 7.5 mg/dL or above) who are not taking uric acid-lowering drugs, patients with gout who are not taking uric acid-lowering drugs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Give the Placebo and test article | Dietary Supplement | Phase 1: The subjects take 2 capsules (500 mg/capsule)/Placebo after dinner every day for 14 days. Phase 2: The subjects take 2 capsules (500 mg/capsule)/test article after dinner every day for 28 days. |
| Measure | Description | Time Frame |
|---|---|---|
| The 20 Subjects Should be Detected the Value of Uric Acid, Glucose ac, TG, TC, HDL and LDL (Unit: mg/dL). | This study aims to evaluate whether taking lactic acid bacteria "LUA probiotics" can reduce blood uric acid levels, and prevent gout symptoms by taking health foods before they occur, avoiding the need to take medication later. Blood sampling points were week 0, week 2, week 6 | Phase 1: The 20 subjects take 2 capsules (500 mg/capsule)/Placebo after dinner for 14 days. Phase 2: The same 20 subjects take 2 capsules (500 mg/capsule)/test article after dinner for 28 days.Blood sampling were at week 0, week 2, week 6. |
| Measure | Description | Time Frame |
|---|---|---|
| The 20 Subjects Should be Detected the Value of Hematology: Hct, RDW-CV, Neu, Lym, Mon, Eos, Bas (Unit: %). | This study aims to evaluate whether taking lactic acid bacteria "LUA probiotics" can reduce blood uric acid levels, and prevent gout symptoms by taking health foods before they occur, avoiding the need to take medication later.Through the analysis of serum biochemistry, hematology and various cytokines in serum, we can obtain the effects of "LUA probiotics" on the human body after consumption. Blood samlping were at week0, week 2 and week 6. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Min-Chih Hsu, Master | Super Laboratory Co., Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | 100229 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37599588 | Result | Cheng S, Shan L, You Z, Xia Y, Zhao Y, Zhang H, Zhao Z. Dietary patterns, uric acid levels, and hyperuricemia: a systematic review and meta-analysis. Food Funct. 2023 Aug 29;14(17):7853-7868. doi: 10.1039/d3fo02004e. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Group - Phase 1 + Phase 2 | Patients with hyperuricemia (uric acid level 7.5 mg/dL or above) who are not taking uric acid-lowering drugs, patients with gout who are not taking uric acid-lowering drugs The 20 subjects were given the Placebo and test article in the different study period: Phase 1: The subjects take 2 capsules (500 mg/capsule)/Placebo after dinner every day for 14 days. Phase 2: The subjects take 2 capsules (500 mg/capsule)/test article after dinner every day for 28 days. There were 20 subjects participating in Phase 1, and the same 20 subjects were also included at the end, and no one withdrew from the clinical trial. Then, the same 20 subjects entered Phase 2, and the same 20 subjects were also included at the end, and no one withdrew from the clinical trial. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Test group - Phase 1 |
| |||||||||||||
| Test group - Phase 2 |
|
Patients were asked about their willingness to participate in this clinical trial through hospital outpatient clinics.
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Group - Phase 1 + Phase 2 | Patients with hyperuricemia (uric acid level 7.5 mg/dL or above) who are not taking uric acid-lowering drugs, patients with gout who are not taking uric acid-lowering drugs The 20 subjects were given the Placebo and test article in the different study period: Phase 1: The subjects take 2 capsules (500 mg/capsule)/Placebo after dinner every day for 14 days. Phase 2: The subjects take 2 capsules (500 mg/capsule)/test article after dinner every day for 28 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The 20 Subjects Should be Detected the Value of Uric Acid, Glucose ac, TG, TC, HDL and LDL (Unit: mg/dL). | This study aims to evaluate whether taking lactic acid bacteria "LUA probiotics" can reduce blood uric acid levels, and prevent gout symptoms by taking health foods before they occur, avoiding the need to take medication later. Blood sampling points were week 0, week 2, week 6 | Posted | Mean | Standard Deviation | mg/dL | Phase 1: The 20 subjects take 2 capsules (500 mg/capsule)/Placebo after dinner for 14 days. Phase 2: The same 20 subjects take 2 capsules (500 mg/capsule)/test article after dinner for 28 days.Blood sampling were at week 0, week 2, week 6. |
|
Adverse events were monitored through study completion (duration: 6 weeks).
Probiotics used in this study are dietary supplements with a low incidence of adverse effects. Participants were informed that minor symptoms such as diarrhea, nausea, abdominal pain, or constipation may occur. In case of more severe or persistent adverse events, participants were advised to discontinue use and report the event to the study team.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients With Hyperuricemia (Uric Acid Level 7.5 mg/dL or Above) | Patients with hyperuricemia (uric acid level 7.5 mg/dL or above) who are not taking uric acid-lowering drugs, patients with gout who are not taking uric acid-lowering drugs Give the Placebo and test article: Phase 1: The subjects take 2 capsules (500 mg/capsule)/Placebo after dinner every day for 14 days. Phase 2: The subjects take 2 capsules (500 mg/capsule)/test article after dinner every day for 28 days. In the experimental design, the same 20 people were planned to be in the placebo group and the experimental group. The main purpose was to use the same 20 people to compare the placebo and the test substance, eliminating the influence of factors between different subjects. |
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The test of IL-1β value were all below the LoD of the IL-1β ELISA Kit.The data were shown as NA ± NA.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jyh-Ming Liou | Department of Internal Medicine, National Taiwan University Hospital | 0972-651883 | jyhmingliou@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 10, 2021 | May 16, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 10, 2021 | May 16, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006073 | Gout |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
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serum
| Phase 1: The 20 subjects take 2 capsules (500 mg/capsule)/Placebo after dinner for 14 days. Phase 2: The same 20 subjects take 2 capsules (500 mg/capsule)/test article after dinner for 28 days.Blood samlping were at week0, week 2 and week 6. |
| The 20 Subjects Should be Detected the Value of 8 Kinds of Cytokine: IL-1β, IL-6, IL-10, IL-13, IL-17, IL-18, TNF-α, IFN-γ (Unit: pg/mL). | This study aims to evaluate whether taking lactic acid bacteria "LUA probiotics" can reduce blood uric acid levels, and prevent gout symptoms by taking health foods before they occur, avoiding the need to take medication later.Through the analysis of serum biochemistry, hematology and various cytokines in serum, we can obtain the effects of "LUA probiotics" on the human body after consumption. Blood samlping were at week 0, week 2 and week 6. | Phase 1: The 20 subjects take 2 capsules (500 mg/capsule)/Placebo after dinner for 14 days. Phase 2: The same 20 subjects take 2 capsules (500 mg/capsule)/test article after dinner for 28 days. Blood samlping were at week 0, week 2 and week 6. |
| The 20 Subjects Should be Detected the Value of Hematology: WBC, PLT (Unit: 10^3 Cells/μL). | This study aims to evaluate whether taking lactic acid bacteria "LUA probiotics" can reduce blood uric acid levels, and prevent gout symptoms by taking health foods before they occur, avoiding the need to take medication later.Through the analysis of serum biochemistry, hematology and various cytokines in serum, we can obtain the effects of "LUA probiotics" on the human body after consumption. Blood samlping were at week0, week 2 and week 6. | Phase 1: The 20 subjects take 2 capsules (500 mg/capsule)/Placebo after dinner for 14 days. Phase 2: The same 20 subjects take 2 capsules (500 mg/capsule)/test article after dinner for 28 days.Blood samlping were at week0, week 2 and week 6. |
| The 20 Subjects Should be Detected the Value of Hematology: Hb, MCHC (Unit: g/dL). | This study aims to evaluate whether taking lactic acid bacteria "LUA probiotics" can reduce blood uric acid levels, and prevent gout symptoms by taking health foods before they occur, avoiding the need to take medication later.Through the analysis of serum biochemistry, hematology and various cytokines in serum, we can obtain the effects of "LUA probiotics" on the human body after consumption. Blood samlping were at week0, week 2 and week 6. | Phase 1: The 20 subjects take 2 capsules (500 mg/capsule)/Placebo after dinner for 14 days. Phase 2: The same 20 subjects take 2 capsules (500 mg/capsule)/test article after dinner for 28 days.Blood samlping were at week0, week 2 and week 6. |
| The 20 Subjects Should be Detected the Value of Hematology: MCV (Unit: fL). | This study aims to evaluate whether taking lactic acid bacteria "LUA probiotics" can reduce blood uric acid levels, and prevent gout symptoms by taking health foods before they occur, avoiding the need to take medication later.Through the analysis of serum biochemistry, hematology and various cytokines in serum, we can obtain the effects of "LUA probiotics" on the human body after consumption. Blood samlping were at week0, week 2 and week 6. | Phase 1: The 20 subjects take 2 capsules (500 mg/capsule)/Placebo after dinner for 14 days. Phase 2: The same 20 subjects take 2 capsules (500 mg/capsule)/test article after dinner for 28 days.Blood samlping were at week0, week 2 and week 6. |
| The 20 Subjects Should be Detected the Value of Hematology: MCH (Unit: pg). | This study aims to evaluate whether taking lactic acid bacteria "LUA probiotics" can reduce blood uric acid levels, and prevent gout symptoms by taking health foods before they occur, avoiding the need to take medication later.Through the analysis of serum biochemistry, hematology and various cytokines in serum, we can obtain the effects of "LUA probiotics" on the human body after consumption. Blood samlping were at week0, week 2 and week 6. | Phase 1: The 20 subjects take 2 capsules (500 mg/capsule)/Placebo after dinner for 14 days. Phase 2: The same 20 subjects take 2 capsules (500 mg/capsule)/test article after dinner for 28 days.Blood samlping were at week0, week 2 and week 6. |
| The 20 Subjects Should be Detected the Value of Hematology:RBC (Unit: 10^6 Cells/μL). | This study aims to evaluate whether taking lactic acid bacteria "LUA probiotics" can reduce blood uric acid levels, and prevent gout symptoms by taking health foods before they occur, avoiding the need to take medication later.Through the analysis of serum biochemistry, hematology and various cytokines in serum, we can obtain the effects of "LUA probiotics" on the human body after consumption. Blood samlping were at week0, week 2 and week 6. | Phase 1: The 20 subjects take 2 capsules (500 mg/capsule)/Placebo after dinner for 14 days. Phase 2: The same 20 subjects take 2 capsules (500 mg/capsule)/test article after dinner for 28 days.Blood samlping were at week0, week 2 and week 6. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | All subjects in this clinical trial are Taiwanese. | Count of Participants | Participants |
|
| Region of Enrollment | All subjects in this clinical trial are Taiwanese | Number | participants |
|
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| Secondary | The 20 Subjects Should be Detected the Value of Hematology: Hct, RDW-CV, Neu, Lym, Mon, Eos, Bas (Unit: %). | This study aims to evaluate whether taking lactic acid bacteria "LUA probiotics" can reduce blood uric acid levels, and prevent gout symptoms by taking health foods before they occur, avoiding the need to take medication later.Through the analysis of serum biochemistry, hematology and various cytokines in serum, we can obtain the effects of "LUA probiotics" on the human body after consumption. Blood samlping were at week0, week 2 and week 6. | Posted | Mean | Standard Deviation | percentage | Phase 1: The 20 subjects take 2 capsules (500 mg/capsule)/Placebo after dinner for 14 days. Phase 2: The same 20 subjects take 2 capsules (500 mg/capsule)/test article after dinner for 28 days.Blood samlping were at week0, week 2 and week 6. |
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| Secondary | The 20 Subjects Should be Detected the Value of 8 Kinds of Cytokine: IL-1β, IL-6, IL-10, IL-13, IL-17, IL-18, TNF-α, IFN-γ (Unit: pg/mL). | This study aims to evaluate whether taking lactic acid bacteria "LUA probiotics" can reduce blood uric acid levels, and prevent gout symptoms by taking health foods before they occur, avoiding the need to take medication later.Through the analysis of serum biochemistry, hematology and various cytokines in serum, we can obtain the effects of "LUA probiotics" on the human body after consumption. Blood samlping were at week 0, week 2 and week 6. | Posted | Mean | Standard Deviation | pg/mL | Phase 1: The 20 subjects take 2 capsules (500 mg/capsule)/Placebo after dinner for 14 days. Phase 2: The same 20 subjects take 2 capsules (500 mg/capsule)/test article after dinner for 28 days. Blood samlping were at week 0, week 2 and week 6. |
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| Secondary | The 20 Subjects Should be Detected the Value of Hematology: WBC, PLT (Unit: 10^3 Cells/μL). | This study aims to evaluate whether taking lactic acid bacteria "LUA probiotics" can reduce blood uric acid levels, and prevent gout symptoms by taking health foods before they occur, avoiding the need to take medication later.Through the analysis of serum biochemistry, hematology and various cytokines in serum, we can obtain the effects of "LUA probiotics" on the human body after consumption. Blood samlping were at week0, week 2 and week 6. | Posted | Mean | Standard Deviation | 10^3 cells/μL | Phase 1: The 20 subjects take 2 capsules (500 mg/capsule)/Placebo after dinner for 14 days. Phase 2: The same 20 subjects take 2 capsules (500 mg/capsule)/test article after dinner for 28 days.Blood samlping were at week0, week 2 and week 6. |
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| Secondary | The 20 Subjects Should be Detected the Value of Hematology: Hb, MCHC (Unit: g/dL). | This study aims to evaluate whether taking lactic acid bacteria "LUA probiotics" can reduce blood uric acid levels, and prevent gout symptoms by taking health foods before they occur, avoiding the need to take medication later.Through the analysis of serum biochemistry, hematology and various cytokines in serum, we can obtain the effects of "LUA probiotics" on the human body after consumption. Blood samlping were at week0, week 2 and week 6. | Posted | Mean | Standard Deviation | g/dL | Phase 1: The 20 subjects take 2 capsules (500 mg/capsule)/Placebo after dinner for 14 days. Phase 2: The same 20 subjects take 2 capsules (500 mg/capsule)/test article after dinner for 28 days.Blood samlping were at week0, week 2 and week 6. |
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| Secondary | The 20 Subjects Should be Detected the Value of Hematology: MCV (Unit: fL). | This study aims to evaluate whether taking lactic acid bacteria "LUA probiotics" can reduce blood uric acid levels, and prevent gout symptoms by taking health foods before they occur, avoiding the need to take medication later.Through the analysis of serum biochemistry, hematology and various cytokines in serum, we can obtain the effects of "LUA probiotics" on the human body after consumption. Blood samlping were at week0, week 2 and week 6. | Posted | Mean | Standard Deviation | fL | Phase 1: The 20 subjects take 2 capsules (500 mg/capsule)/Placebo after dinner for 14 days. Phase 2: The same 20 subjects take 2 capsules (500 mg/capsule)/test article after dinner for 28 days.Blood samlping were at week0, week 2 and week 6. |
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| Secondary | The 20 Subjects Should be Detected the Value of Hematology: MCH (Unit: pg). | This study aims to evaluate whether taking lactic acid bacteria "LUA probiotics" can reduce blood uric acid levels, and prevent gout symptoms by taking health foods before they occur, avoiding the need to take medication later.Through the analysis of serum biochemistry, hematology and various cytokines in serum, we can obtain the effects of "LUA probiotics" on the human body after consumption. Blood samlping were at week0, week 2 and week 6. | Posted | Mean | Standard Deviation | pg | Phase 1: The 20 subjects take 2 capsules (500 mg/capsule)/Placebo after dinner for 14 days. Phase 2: The same 20 subjects take 2 capsules (500 mg/capsule)/test article after dinner for 28 days.Blood samlping were at week0, week 2 and week 6. |
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| Secondary | The 20 Subjects Should be Detected the Value of Hematology:RBC (Unit: 10^6 Cells/μL). | This study aims to evaluate whether taking lactic acid bacteria "LUA probiotics" can reduce blood uric acid levels, and prevent gout symptoms by taking health foods before they occur, avoiding the need to take medication later.Through the analysis of serum biochemistry, hematology and various cytokines in serum, we can obtain the effects of "LUA probiotics" on the human body after consumption. Blood samlping were at week0, week 2 and week 6. | Posted | Mean | Standard Deviation | 10^6 cells/μL | Phase 1: The 20 subjects take 2 capsules (500 mg/capsule)/Placebo after dinner for 14 days. Phase 2: The same 20 subjects take 2 capsules (500 mg/capsule)/test article after dinner for 28 days.Blood samlping were at week0, week 2 and week 6. |
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| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
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| D012216 |
| Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| Title | Measurements |
|---|---|
|
| Lymphocyte (%)-week 0 |
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| Monocyte (%)-week 0 |
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| Eosinophil (%)-week 0 |
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| Basophil (%)-week 0 |
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| Hct (%)-week 2 |
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| RDW-CV (%)-week 2 |
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| Neutrophil (%)-week 2 |
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| Lymphocyte (%)-week 2 |
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| Monocyte (%)-week 2 |
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| Eosinophil (%)-week 2 |
|
| Basophil (%)-week 2 |
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| Hct (%)-week 6 |
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| RDW-CV (%)-week 6 |
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| Neutrophil (%)-week 6 |
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| Lymphocyte (%)-week 6 |
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| Monocyte (%)-week 6 |
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| Eosinophil (%)-week 6 |
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| Basophil (%)-week 6 |
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| IL-13 - week 0 |
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| IL-17 - week 0 |
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| IL-18 - week 0 |
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| TNF-α - week 0 |
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| IFN-γ - week 0 |
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| IL-1β - week 2 |
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| IL-6 - week 2 |
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| IL-10 - week 2 |
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| IL-13 - week 2 |
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| IL-17 - week 2 |
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| IL-18 - week 2 |
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| TNF-α - week 2 |
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| IFN-γ - week 2 |
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| IL-1β - week 6 |
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| IL-6 - week 6 |
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| IL-10 - week 6 |
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| IL-13 - week 6 |
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| IL-17 - week 6 |
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| IL-18 - week 6 |
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| TNF-α - week 6 |
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| IFN-γ - week 6 |
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| Title | Measurements |
|---|---|
|
| PLT (10^3 cells/μL)-week 2 |
|
| WBC (10^3 cells/μL)-week 6 |
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| PLT (10^3 cells/μL)-week 6 |
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| Title | Measurements |
|---|---|
|
| MCHC (g/dL)-week 2 |
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| Hb (g/dL)-week 6 |
|
| MCHC (g/dL)-week 6 |
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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