Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study is to evaluate whether the TCI604 probiotics has the potential to enhance human gut function and alleviate constipation.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Taking 1 sachet of the testing sample with water every morning before breakfast for 4 consecutive weeks |
|
| TCI604 probiotics | Experimental | Taking 1 sachet of the testing sample with water every morning before breakfast for 4 consecutive weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TCI604 probiotics | Dietary Supplement | TCI604 probiotics sachet |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change of stool form | The stool type will be assessed by The Bristol Stool Form Scale (BSFS). The BSFS is a scale that classifies stools, ranging from the hardest (type 1) to the softest (type 7). | Week 0 (Baseline), Week 2, Week 4 |
| The change of bowel movement and gastrointestinal discomforts | The Gastrointestinal Symptom Rating Scale (GSRS) will be utilized to assess the bowel movement and gastrointestinal discomforts. The GSRS consists of 15 items, each rated on a 7-point Likert scale. A higher score indicates more severe and frequent symptoms.The total GSRS score is calculated by taking the average score of the five symptom categories- Reflux, Abdominal Pain, Indigestion, Diarrhea, and Constipation- summing them up, and then dividing the total by five to obtain the overall mean score. | Week 0 (Baseline), Week 2, Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| The change of intestinal microbiota | Collect participant's feces for bacterial analysis. Intestinal microbiota will be assessed by Next Generation Sequencing (NGS). | Week 0 (Baseline), Week 4 |
| The change of serum Interleukin-6 level |
| Measure | Description | Time Frame |
|---|---|---|
| The change of Body weight | Body weight will be assessed by Body Composition Analyzer. Unit: kg | Week 0 (Baseline), Week 4 |
| The change of Body Mass Index | Body Mass Index (BMI) level will be assessed by Body Composition Analyzer. Unit: kg/cm^2 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ping Lin, Ms. | Contact | +886-87977811 | candice.lin@tci-bio.com |
| Name | Affiliation | Role |
|---|---|---|
| Jaw-Shiun Tsai, Doctor | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Recruiting | Taipei | 100 | Taiwan |
Not provided
| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Dietary Supplement | Placebo sachet |
|
A fasting blood sample will be collected for Interleukin-6 (IL-6) testing using an Enzyme-Linked Immunosorbent Assay kit.
| Week 0 (Baseline), Week 4 |
| The change of serum Interleukin-8 level | A fasting blood sample will be collected for Interleukin-8 (IL-8) testing using an Enzyme-Linked Immunosorbent Assay kit. | Week 0 (Baseline), Week 4 |
| The change of serum Interleukin-10 level | A fasting blood sample will be collected for Interleukin-10 (IL-10) testing using an Enzyme-Linked Immunosorbent Assay kit. | Week 0 (Baseline), Week 4 |
| The change of serum Interleukin-17A level | A fasting blood sample will be collected for Interleukin-17A (IL-17A) testing using an Enzyme-Linked Immunosorbent Assay kit. | Week 0 (Baseline), Week 4 |
| The change of blood High-sensitivity C-Reactive Protein level | Venous blood samples will be collected to measure concentrations of High-sensitivity C-Reactive Protein. | Week 0 (Baseline), Week 4 |
| The change of serum Lipopolysaccharide binding protein level | A fasting blood sample will be collected for Lipopolysaccharide testing using an Enzyme-Linked Immunosorbent Assay kit. | Week 0 (Baseline), Week 4 |
| The change of serum neopterin level | A fasting blood sample will be collected for neopterin testing using an Enzyme-Linked Immunosorbent Assay kit. | Week 0 (Baseline), Week 4 |
| The change of intestinal fecal loading | Intestinal fecal loading will be evaluated using abdominal X-ray imaging. | Week 0 (Baseline), Week 4 |
| Week 0 (Baseline), Week 4 |
| The change of Percent Body Fat | Percent Body Fat will be assessed by Bioelectrical Impedance Analysis (BIA) method. Unit: Percent | Week 0 (Baseline), Week 4 |
| The change of Visceral Fat Level | Visceral Fat Level will be assessed by Bioelectrical Impedance Analysis (BIA) method. Unit: arbitrary unit | Week 0 (Baseline), Week 4 |
| The change of waist and hip circumference | Waist and hip circumference will be assessed by measuring tape. | Week 0 (Baseline), Week 4 |
| The change of blood pressure | Systolic pressure and diastolic pressure will be assessed by sphygmomanometer. | Week 0 (Baseline), Week 4 |
| The change of blood lipids profiles | Venous blood will be sampled to measure concentrations of total cholesterol, High Density Lipoprotein Cholesterol, Low Density Lipoprotein Cholesterol, and triglyceride. | Week 0 (Baseline), Week 4 |
| The change of blood liver function biomarkers (AST, ALT) | Venous blood will be sampled to measure concentrations of liver function biomarkers. | Week 0 (Baseline), Week 4 |
| The change of blood renal function biomarkers (creatinine, BUN) | Venous blood will be sampled to measure concentrations of renal function biomarkers. | Week 0 (Baseline), Week 4 |
| The change of blood fasting glucose level | Venous blood will be sampled to measure concentrations of fasting glucose level. | Week 0 (Baseline), Week 4 |
| The change of blood cells counts | Venous blood will be sampled to measure the blood cells counts, including white blood cell (WBC) count/automated differential, red blood cell (RBC) count, platelet count. Unit: count/uL | Week 0 (Baseline), Week 4 |
| The change of hemoglobin | Venous blood will be sampled to measure the hemoglobin. Unit: g/dL | Week 0 (Baseline), Week 4 |
| The change of hematocrit | Venous blood will be sampled to measure the hematocrit. Unit: % | Week 0 (Baseline), Week 4 |
| The change of mean corpuscular volume | Venous blood will be sampled to measure the mean corpuscular volume (M.C.V). Unit: fl | Week 0 (Baseline), Week 4 |
| The change of mean corpuscular hemoglobin concentration | Venous blood will be sampled to measure the mean corpuscular hemoglobin concentration (M.C.H.C). Unit: g/dL | Week 0 (Baseline), Week 4 |