Constipation, Intestinal Functional Disorder
Conditions
Keywords
Bifidobacterium animalis subsp. lactis
Brief summary
The objective of this study is to evaluate whether the TCI604 probiotics has the potential to enhance human gut function and alleviate constipation.
Interventions
DIETARY_SUPPLEMENTTCI604 probiotics
TCI604 probiotics sachet
DIETARY_SUPPLEMENTPlacebo
Placebo sachet
Sponsors
TCI Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or non-pregnant female subjects aged 18 to 65 who are willing to sign the informed consent form; * Diagnosed with functional constipation as assessed by a physician; * Non-pregnant females who agree to use physical contraceptive methods during the study period (e.g., condoms, intrauterine devices); * No history of organ transplantation, epilepsy or seizures, liver or kidney disease, malignancy, psychiatric disorders, alcohol or drug abuse, or other major organic diseases (as determined by medical history).
Exclusion criteria
* Use of probiotics, gastrointestinal health supplements, medications, or antibiotics within 30 days prior to the study; * Presence of chronic gastrointestinal diseases (e.g., irritable bowel syndrome \[IBS\], inflammatory bowel disease \[IBD\], Crohn's disease, celiac disease, bowel control problems/fecal incontinence, pancreatitis, peptic ulcers, colorectal cancer, short bowel syndrome, ulcerative colitis); * History of gastrointestinal or major surgery; * Lactose intolerance; * Chronic diarrhea; * Pregnant or breastfeeding women; * Known allergy to any components of the study product.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change of stool form | Week 0 (Baseline), Week 2, Week 4 | 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). |
| The change of bowel movement and gastrointestinal discomforts | Week 0 (Baseline), Week 2, Week 4 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change of serum Interleukin-8 level | Week 0 (Baseline), Week 4 | A fasting blood sample will be collected for Interleukin-8 (IL-8) testing using an Enzyme-Linked Immunosorbent Assay kit. |
| The change of serum Interleukin-10 level | Week 0 (Baseline), Week 4 | A fasting blood sample will be collected for Interleukin-10 (IL-10) testing using an Enzyme-Linked Immunosorbent Assay kit. |
| The change of serum Interleukin-17A level | Week 0 (Baseline), Week 4 | A fasting blood sample will be collected for Interleukin-17A (IL-17A) testing using an Enzyme-Linked Immunosorbent Assay kit. |
| The change of intestinal microbiota | Week 0 (Baseline), Week 4 | Collect participant's feces for bacterial analysis. Intestinal microbiota will be assessed by Next Generation Sequencing (NGS). |
| The change of serum Lipopolysaccharide binding protein level | Week 0 (Baseline), Week 4 | A fasting blood sample will be collected for Lipopolysaccharide testing using an Enzyme-Linked Immunosorbent Assay kit. |
| The change of serum neopterin level | Week 0 (Baseline), Week 4 | A fasting blood sample will be collected for neopterin testing using an Enzyme-Linked Immunosorbent Assay kit. |
| The change of intestinal fecal loading | Week 0 (Baseline), Week 4 | Intestinal fecal loading will be evaluated using abdominal X-ray imaging. |
| The change of blood High-sensitivity C-Reactive Protein level | Week 0 (Baseline), Week 4 | Venous blood samples will be collected to measure concentrations of High-sensitivity C-Reactive Protein. |
| The change of serum Interleukin-6 level | Week 0 (Baseline), Week 4 | A fasting blood sample will be collected for Interleukin-6 (IL-6) testing using an Enzyme-Linked Immunosorbent Assay kit. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The change of hemoglobin | Week 0 (Baseline), Week 4 | Venous blood will be sampled to measure the hemoglobin. Unit: g/dL |
| The change of hematocrit | Week 0 (Baseline), Week 4 | Venous blood will be sampled to measure the hematocrit. Unit: % |
| The change of Body weight | Week 0 (Baseline), Week 4 | Body weight will be assessed by Body Composition Analyzer. Unit: kg |
| The change of mean corpuscular hemoglobin concentration | Week 0 (Baseline), Week 4 | Venous blood will be sampled to measure the mean corpuscular hemoglobin concentration (M.C.H.C). Unit: g/dL |
| The change of mean corpuscular volume | Week 0 (Baseline), Week 4 | Venous blood will be sampled to measure the mean corpuscular volume (M.C.V). Unit: fl |
| The change of Body Mass Index | Week 0 (Baseline), Week 4 | Body Mass Index (BMI) level will be assessed by Body Composition Analyzer. Unit: kg/cm\^2 |
| The change of Percent Body Fat | Week 0 (Baseline), Week 4 | Percent Body Fat will be assessed by Bioelectrical Impedance Analysis (BIA) method. Unit: Percent |
| The change of Visceral Fat Level | Week 0 (Baseline), Week 4 | Visceral Fat Level will be assessed by Bioelectrical Impedance Analysis (BIA) method. Unit: arbitrary unit |
| The change of waist and hip circumference | Week 0 (Baseline), Week 4 | Waist and hip circumference will be assessed by measuring tape. |
| The change of blood pressure | Week 0 (Baseline), Week 4 | Systolic pressure and diastolic pressure will be assessed by sphygmomanometer. |
| The change of blood lipids profiles | Week 0 (Baseline), Week 4 | Venous blood will be sampled to measure concentrations of total cholesterol, High Density Lipoprotein Cholesterol, Low Density Lipoprotein Cholesterol, and triglyceride. |
| The change of blood liver function biomarkers (AST, ALT) | Week 0 (Baseline), Week 4 | Venous blood will be sampled to measure concentrations of liver function biomarkers. |
| The change of blood renal function biomarkers (creatinine, BUN) | Week 0 (Baseline), Week 4 | Venous blood will be sampled to measure concentrations of renal function biomarkers. |
| The change of blood fasting glucose level | Week 0 (Baseline), Week 4 | Venous blood will be sampled to measure concentrations of fasting glucose level. |
| The change of blood cells counts | Week 0 (Baseline), Week 4 | 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 |
Countries
Taiwan
Contacts
Primary ContactPing Lin, Ms.
Outcome results
None listed